Author name: Robert Packard

Which Countries Require CE Marking of Medical Devices?

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28 Member States 2013 Which Countries Require CE Marking of Medical Devices?

This blog serves as a reference guide with a discussion of information resources for, and a list of which countries require CE marking of medical devices.

You can locate the current list of countries that require CE Marking of medical devices by visiting the list of Competent Authorities (CAs) on the following Europa webpage (http://bit.ly/ContactPoints). That page has 33 national CAs identified. CAs are the US FDA equivalent in the European Union (EU). In addition to member states in the EU, the CAs list also includes signatories (i.e., – countries that have signed the 1985 Schengen Agreement to allow people to pass between countries with no border controls) and EU candidate member states. For the most current status of candidate member states and potential candidate member states, you can visit the following Europa webpage: (http://bit.ly/EuropaCountries). As of September 21, 2013, the status of the 33 CAs is categorized in the list at the end of this blog posting.

Australia-EU Mutual Recognition Agreement

In addition to the 33 countries listed below, the Australia Therapeutic Goods Administration (TGA) has a mutual recognition agreement with the EU—the EC MRA (http://bit.ly/TGA-EU-MRA). This agreement, however, has limitations. The agreement includes a rule of origin clause which excludes products manufactured outside the EU and Australia. Other restrictions include:

  • Radioactive medical devices
  • High-Risk, Class III devices
  • Excluded barrier contraceptives, including condoms
  • Devices, including medicinal and those of biological origin
Kingdom of Saudi Arabia

In the Kingdom of Saudi Arabia (KSA), you can begin the medical device registration process if your company has regulatory approval from one of the founding members of the Global Harmonization Task Force (GHTF). The five founding members are: 1) the USA, requiring a 510(k) or PMA; 2) Canada, requiring a Medical Device License; 3) Europe, requiring CE Marking; 4) Australia, requiring Australian Register of Therapeutic Goods (ARTG); and 5) Japan, requiring Japanese Pharmaceutical Affairs Law (JPAL) certification or approval. The next step is to select an Authorized Representative in the KSA and submit a Medical Device Marketing Authorization (MDMA) application. For low and medium risk device classifications (i.e., – Class I, IIa, and IIb), you may begin marketing your device in the KSA before obtaining formal regulatory approval (this regulation is subject to potential change). For higher-risk devices (i.e., – Class III), you must first obtain MDMA certification before distribution of the device in the KSA. The medical device regulations for the KSA are interim regulations. You can verify the current regulations by visiting the Saudi Food and Drug Authority (SFDA) website (http://bit.ly/SFDAMedicalDevices).

Other Countries

Many other countries have alternate, abbreviated processes similar to Australia and the KSA if your medical device is already approved by one of the GHTF countries. Often, this is stated as “country of origin approval.” Countries recognizing country of origin approval that offer an abbreviated approval process include Argentina, Singapore, China, etc. These countries do not merely “rubber stamp” the approval, but the approval process is less rigorous.

If your product is manufactured in the US, but you do not have a PMA or 510(k) issued by the US FDA, a CE certificate is not enough. Your company must establish a country of origin status in Europe to take advantage of the abbreviated approval processes. This is sometimes done by establishing a facility in Europe, but the CE certificate must be issued to the European facility. Other workarounds have been developed, but that is beyond the scope of this blog.

2 EU Candidate Member States with Competent Authorities

These two countries below are candidate member states for joining the EU. These countries are not signatories, but both countries have established a competent authority for reporting recalls and vigilance related to medical devices distributed within their borders. Turkey has also has established four Notified Bodies.

  1. Iceland
  2. Turkey

3 EEA Signatories with Competent Authorities

For a long time, Switzerland was neither a member of the EU nor a signatory. However, in 2008, Switzerland became the 25th country to sign the Schengen Agreement, which allows people to pass between countries with no border controls. All three countries below have established a competent authority. Switzerland has established five Notified Bodies, and Norway has two.

  1. Liechtenstein
  2. Norway
  3. Switzerland

28 EU Member States with Competent Authorities

The list below identifies the 28 members of the EU. The date in parenthesis is the year that each member joined the EU. All of these countries have competent authorities that regulate medical devices, and many of these countries have established Notified Bodies. Germany, Italy and the UK have the greatest number of Notified Bodies.

  1. Austria (1995)
  2. Belgium (1952)
  3. Bulgaria (2007)
  4. Croatia (2013)
  5. Cyprus (2004)
  6. Czech Republic (2004)
  7. Denmark (1973)
  8. Estonia (2004)
  9. Finland (1995)
  10. France (1952)
  11. Germany (1952)
  12. Greece (1981)
  13. Hungary (2004)
  14. Ireland (1973)
  15. Italy (1952)
  16. Latvia (2004)
  17. Lithuania (2004)
  18. Luxembourg (1952)
  19. Malta (2004)
  20. Netherlands (1952)
  21. Poland (2004)
  22. Portugal (1986)
  23. Romania (2007)
  24. Slovakia (2004)
  25. Slovenia (2004)
  26. Spain (1986)
  27. Sweden (1995)
  28. United Kingdom (1973)

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EU Takes Next Step in Approving Proposed Medical Device Regulations

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Brussels, September 24-25, 2013

EC Press Release EU Takes Next Step in Approving Proposed Medical Device Regulations

This article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations.

Today, the EU Parliament Committee on the Environment, Public Health and Food Safety (ENVI) approved~900 amendments; estimated by Amanda Maxwell (http://bit.ly/AmandaMaxwell) in today’s Clinica article; to the proposed EU medical device regulations. Today’s approval by the ENVI Committee should be a warning sign that the new regulations will ultimately be approved, and this will be the most significant change in the medical device industry since the implementation of the QSR (http://bit.ly/QSRpreamble) in the 1990s.

The EU Commission originally released the amendments on September 26, 2012 (http://bit.ly/EUProposal).

Also, last night the EU Commission announced the adoption of two new stricter rules regarding Notified Bodies (NBs) and their role in CE Marking of medical devices. The lack of resistance to controversial elements within the proposal was shocking, and the coordinated release of new Notified Body requirements should be a warning sign to the medical device industry. The European CE Marking process will be changing soon.

Click here to download the above documents from the Medical Device Academy website.

EU Commission Press Release

The Commission’s press release announced two new documents. The first is regulation for NBs. The regulation is dependent upon four things: 1) formation of a Medical Device Advisory Committee (MDAC), 2) formation of a Medical Device Coordination Group (MDCG), 3) identification and qualification of Special Notified Bodies (SNBs), and 4) formation of an Assessment Committee for Medical Devices (ACMD). These new entities were passed in the compromise amendment, but these groups and committees will consist of representatives from multiple member states and multiple NBs. This type of matrix organization will require extensive planning and preparation. Until an implementation plan is well-defined, I don’t expect a plenary vote. For now, we have a compromise that was voted on by a committee.

The second document released by the Commission is the recommendation concerning NBs performing conformity assessments. The recommendation is not limited to just unannounced audits. There are three Annexes:

  1. Annex I – Product Assessment
  2. Annex II – Quality System Assessment
  3. Annex III – Unannounced Audits

You should also note that Annex II includes a section specific to “General advice in case of outsourcing of the production via subcontractors or suppliers.” This requirement will challenge companies that have outsourced manufacturing, and the wording of this section can easily be misinterpreted by an auditor and the NBs. Annex III also includes a requirement regarding the contractual arrangement between the NB and the manufacturer. This will force NBs to revise and execute new contracts with all of their clients to allow these new conformity assessment procedures to be fully implemented.

Eucamed’s Political Positioning

On January 30, 2013, Eucamed released an industry position paper on the proposed regulations (http://bit.ly/EucamedPositionPaper). In general, the position paper supported the proposal. However, the position paper also states that it is in support of regulations that:

  • ensures timely access to the latest innovative technologies, and
  • maintains an environment that encourages and keeps research and innovation in Europe.

On September 12, 2013, Eucamed released the results of an industry survey (http://bit.ly/CostofEURegs) stating that the cost of the proposed regulations would be 17.5 Billion Euros. The details of the survey indicate that the implementation of the Unique Device Identifier (UDI) system, improved labeling, and clinical performance data will require a 7.5 billion Euro investment. Also, industry survey respondents indicated that an additional 2.5 million Euro investment would be needed for each new Class III device that is required to undergo the proposed Scrutiny process in Article 44. The release of the Eucamed survey was only six days before the rescheduled ENVI vote on September 18, 2013—which was delayed for the third time until today.

Next Step in the Proposed Medical Device Regulations Approval Process

Now that the amended proposal has passed the vote, the next step is the plenary vote. This is scheduled for October 22, 2013, but there is some discussion as to whether the plenary vote should occur within 21 days of the ENVI vote to comply with a previous legal ruling. October 22 does not give Parliament adequate time to make any significant revisions to the compromise amendments—let alone 21 days. Therefore, I DO NOT expect the plenary vote to pass. I do not expect a vote. I expect Eucamed and industry lobbyists to be busy during the next few weeks. Opponents of the regulations will focus on three failures of the compromise amendment:

  1. the implementation cost is not acceptable during a European economic crisis
  2. the scrutiny mechanism in Article 44 of the proposal has the potential to delay CE Marking of Class IIb and Class III device by an additional 3-6 months, and the scrutiny process is guaranteed to result in more conservative NB recommendations
  3. the Europeans do not want to hear a great sucking sound as research and clinical study dollars are rapidly moved from Europe to more favorable nations
Why is there a Rush?

European elections were in 2014. The government officials in the office want to approve the regulations before the elections, but it’s not going to happen. To address the public concern related to the PIP scandal (http://bit.ly/MHRAReport) where industrial silicone was fraudulently used for breast implants, the EU Commission has finally taken actions they promised:

  1. NBs are being re-evaluated according to far more stringent regulations (download Commission Implementing Regulation IP-13-854 from our website),
  2. Two NBs are no longer allowed to issue new certificates, and
  3. Recommendations for conducting unannounced inspections are released (yesterday), and NBs are conducting unannounced inspections (11 so far, and 19 by the end of the year).

This is significant progress, but the regulations are missing a mechanism from the scrutiny process resulting in CE Marking delays that would impact future investment in Europe and timely access to the latest medical devices. Parliament also needs time for a rebuttal of the Eucamed industry survey claiming high costs of implementation.

My prediction is that we will not see a vote for approval in Parliament on October 22. However, today’s approval by the ENVI Committee should be a warning sign. The new regulations will ultimately be approved, and this will be the most significant change in the medical device industry since the implementation of the QSR (http://bit.ly/QSRpreamble) in the 1990s.

Medical companies should be paying more attention to the proposed regulations. To comply, you will need to make significant changes to your supplier quality agreements and your Technical Documentation (i.e., – Technical File/Design Dossier). You should be drafting a quality plan for the implementation of these changes to your quality system now because it will take you more than a year to achieve compliance with these changes.

For additional information, visit the Europa website: http://bit.ly/ECUpdates.

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8 success tips for the first 30 minutes of an FDA inspection

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fda30min 300x156 8 success tips for the first 30 minutes of an FDA inspectionThe author presents an 8 item action plan and discussion for getting your FDA inspection off to a good start, beginning when the FDA enters your facility. When an FDA inspector arrives at the reception desk of your facility, the last thing that you want is a Keystone Kops scenario with people running around in a panic and keeping the inspector waiting. This is your first opportunity to make a professional impression, and you never want to give an inspector the impression that you have something to hide. What happens during the first 30 minutes of arrival is critical. While medical device inspections are often announced several days in advance, there is no obligation for the Agency to do so. Therefore, your team needs training and a plan. This training should involve more than just reading the Quality System Inspection Technique (QSIT) manual (http://bit.ly/QSITManual), and conducting a mock FDA inspection. Last year, Rob Packard wrote a blog about “10 FDA Inspection Strategies that Don’t Work” (http://bit.ly/QSITmistakes), but the following activities need to be executed in the first 30 minutes to ensure your next inspection starts smoothly.

The FDA Inspection: 8 Immediate Actions to Take

1. Receptionist-Personnel Contacts  (Time Zero)

I once witnessed a receptionist sarcastically comment to an inspector that people must be thrilled when they walk in the door. That was not a great start to the inspection. Ensure that your receptionist and additional personnel who may sit at the desk are trained, understand what to do, and know-how to behave when an FDA inspector(s) arrives. This exercise should not cause panic. You need a simple work instruction located at the reception desk and a list of key staff members to contact immediately. The head of the Quality department, or Management Representative, is usually the first call.

2. Have Chain of Command in Place (Time = 1 minute)

DO NOT keep the inspector waiting in the lobby. Have a communication chain in place to ensure that other appropriate personnel is available in the event that the first point of contact cannot be reached. It is reasonable to ask the inspector to return at a later date ONLY if all individuals with the technical expertise to participate in the inspection are not on-site, or are out of the country. The agent will decide whether to honor this request, but the expectation is that there is always someone with whom they can work with. Never make this request to put off the inevitable.

3. Ask To See Inspector Credentials (Time = 2 minutes)

Ask to see the inspector’s credentials, and ensure that you give them more than a cursory glance. This is important to avoid allowing an imposter posing as an Agency employee from gaining access to your business. While a rare occurrence, it has been known to happen. Some investigators are officers of the Public Health Service and may be in uniform. However, even these officers are not required to wear a uniform for all visits. Note:  Section 5.1.1.2 of the FDA Investigations Operations Manual (http://bit.ly/FDAIOM) instructs inspectors to provide their credentials to top management, but copying of official credentials is not allowed.

4. Escort Inspector to Inspection Room (Time = 5 minutes)

Make sure that you can have the inspector escorted to a suitable room with the respective hosts within five minutes of arrival. This will involve ensuring that it is clearly understood by all administrative staff and key management that any other meeting may need to be curtailed, or moved immediately to another location to provide an appropriate space for the inspection. Providing substandard accommodations, such as a very cold or warm room, is not a good strategy for shortening the inspection time, and is a ploy easily recognized by the Agency, though not appreciated. Note:  Rob Packard taught an audio seminar earlier this year, where the use of inspection war rooms was covered in more detail—including a diagram with a proposed layout for the room (http://bit.ly/FDAInspectionSeminar).

5. Ready the FDA Inspection War Room (Time = 10 minutes)

Immediately after your inspection room is identified, you need to prepare your backroom or “war room.” This room should be located near the inspection room and set up at a moment’s notice with staff who can expertly execute their respective roles. You will need a mode of communication between the inspection and war rooms, runners to retrieve documents and records in the shortest time possible, as well as a technical individual to review these documents to ensure that they are appropriate and accurate before being provided to the inspector. This room should be ready within ten minutes of arrival.

6. Ensure You Have Emergency Supplies & Copies (Time = 15 minutes)

Your war room will need supplies. You should have a mobile cart equipped with inspection supplies ready and waiting at all times. Suggestions for the contents of your war room cart include a laptop, projector, staplers, staples, pens, blank folders, a label maker, and a stamp for “uncontrolled copies.” Your supplies need to make it to the war room within 15 minutes of arrival.

7. Ready the Frequently Requested Documents (Time = 25 minutes)

Don’t wait for the inspector to tell you which documents are invariably requested at the outset of any inspection. This includes, but is not limited to, the organizational chart, an index of all procedures, CAPA log, and your nonconformance logs for medical devices—all dating back to the last inspection. This doesn’t mean that you should offer these documents to the inspector. You want to prepare these before they are requested so that they can be provided quickly, but you should keep the copies in the war room until the inspector requests each document and record. Copies of these records and documents should be stamped and ready within 25 minutes of arrival.

8. Relax (Time = 30 minutes)

It sounds as though this process is a race against time. It is not. No one engaging with the inspector should be running in and out of the room, gasping for breath, or sweating profusely from the effort. Keeping the inspector waiting can be perceived as a stall tactic, perhaps arousing suspicion that you are creating records “on the fly” in the war room (definitely not a strategy that I recommend), or that you are having difficulty locating the requested documents, and are not in control of your Quality Management System (QMS). The most important aspect is to manage your QMS so that you are always ready for an inspection at a moment’s notice. If you prepare in advance, you shouldn’t need to do anything more than ask if the inspector would like coffee before the inspection begins.

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What Does the CE Mark Mean, and What is its Purpose?

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CE Marking Examples What Does the CE Mark Mean, and What is its Purpose?

The author answers the question of what does the CE Mark means, what its purpose is related to medical devices and regulatory requirements, if applicable.

To facilitate trade throughout the European Economic Area (EEA), products need to be identified as compliant with regional and national regulations. In the EEA, this identification is the CE Mark. “CE” is not an acronym. The mark indicates compliance of your product with the essential requirements in the applicable directive. In the case of medical devices, there are three directives:

  1. Medical Device Directive, 93/42/EEC (http://bit.ly/M5MDD),
  2. Active Implantable Medical Devices Directive, 90/385/EEC (http://bit.ly/AIMDDirective)
  3. In Vitro Diagnostics Directive, 98/79/EC (http://bit.ly/currentIVDD).

Prior to the existence of these three directives, medical devices were compliant with the regulations of individual member states. These regulations were extremely detailed and created a barrier to the transport of products between the member states. With the implementation of the new approach directive (http://bit.ly/Resolution85), companies were able to CE Mark medical devices in accordance with one of the three device directives, and medical device products began to flow smoothly throughout the EEA.

Notified Body Numbers

The images at the top of this blog posting are examples of CE Marks from two of the largest medical device Notified Bodies. The four-digit numbers identify the Notified Body (NB) that issued the CE Certificate for the medical device. This number is only used for medical devices requiring NB involvement. Therefore, non-sterile Class I medical devices that do not have a measurement function are required only to have the “CE” on their labeling. All other medical devices are required to have the “CE” with the NB four-digit number. If one of the Competent Authorities (CAs), the equivalent to the U.S. FDA in each member state, wants to determine which Notified Body is authorizing the CE Marking of a medical device, the CA will look-up the four-digit number on the following NB database (http://bit.ly/NBDatabase).

How to Reproduce the Mark

It is the legal manufacturer’s responsibility to design their labeling with the CE and NB number—if applicable. This labeling is included in the company’s Technical File, and the NB reviews the Technical File for compliance with the essential requirements in one of the three device directives. For medical devices, the instructions for CE Marking are defined in Annex XII of 93/42/EEC. For active implantable devices, the requirements are found in Annex 9 of 90/385/EEC. For in vitro diagnostic devices, the requirements for CE Marking are found in Annex X of Directive 98/79/EC.

These three Annexes are identical and provide a graduated drawing showing the exact proportions of the “C” and “E” relative to one another. These Annexes also state that “”The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.”” You can obtain a free download of the mark on the Europa website (http://bit.ly/DownloadCE).

The four-digit NB number is intended to be the same boldness and font as the “”CE”” characters. Therefore, NBs have interpreted the requirement to specify numbers that are at least half the height of the “C” and “E”—or at least 2.5 mm. Each NB also provides instructions to legal manufacturers on how to present the CE characters with their four-digit NB number. Usually, there are a couple of different orientations that are allowed by the NB. For small products, it may not be possible to mark the device with a “C” and “E” that is at least 5 mm. Therefore, the directives waive this minimum dimension for small-scale devices. Most companies, however, will place a “C” and “E” on their labeling that is at least 5 mm in height, instead of marking parts with a “CE” that is illegible.

Use and Misuse of CE Marking

Most companies want to use CE Marking on all product labeling, even for products sold outside the EEA, because other countries recognize it and associate it with safety and performance. It is also acceptable to use the “CE” in product literature. However, it is important that it appears next to product images or descriptions that have a valid CE Certificate. It is not acceptable to use the “CE” in a way that it might imply that other products have a CE Certificate when the products do not. It is also not acceptable to use the “CE” in a way that it might imply a corporate entity is “CE Marked.” CE Certificates are for products—not for companies.

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Risk Classification Process for Health Canada Device Licensing

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Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents.

Last week, I was visiting a client who was told that their device is a higher risk device classification (i.e., – Class IV) in Canada than it is in Europe (i.e., – Class IIa). Although Canada has its own device classification rules, there are many similarities with European Classifications for CE Marking. A few months ago, I posted a gap analysis (http://bit.ly/gapanalysiscmda) comparing the classification rules in the current MDD (http://bit.ly/M5MDD) to the new classification rules in the proposed European Device Regulations (http://bit.ly/EUProposal). Now, let’s review the Canadian classification rules versus the current European classification rules.

Overview of the European and Canadian Medical Device Classification Rules

There are four European and Canadian medical device classifications. Class I, IIa, IIb, and III are the European classifications, while Class I, II, III, and IV are the Canadian classifications. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR).

canada class blog Risk Classification Process for Health Canada Device Licensing

There are 16 risk-based classification rules, with a similar format and organization to the 18 risk-based classification rules in the MDD. Just a glance at the table above reveals that the classification rules for Europe and Canada are similar. However, a closer comparison between the two regulations shows that Rules 1-14 in the CMDR match-up with part or all of a corresponding European classification. Only rules 15 and 16 do not have a corresponding European classification rule.

How to Write a Classification Rationale for Health Canada

Two weeks ago, I wrote a blog (http://bit.ly/riskclass) on how to write a classification rationale for CE Marking of Medical Devices. That blog made use of the European guidance document for the classification of medical devices (http://bit.ly/EUClassification). For Canadian Medical Device License Applications, there is a different guidance document (http://bit.ly/CMDRClassificationGuidance). However, if you already have a European device classification, I recommend the following strategy:

  1. Identify the equivalent classification rule in the CMDR
  2. Write a classification rationale using the rule you identified in the CMDR
  3. Send your classification rationale to the Canadian Medical Device Licensing Division for verification (http://bit.ly/CanadianMDL)

If you have any trouble with step 1, you might try doing a keyword search of an electronic version. For example, the word “gases” in rule 2 of Annex IX in the MDD only appears once in the CMDR classification rules—in rule 5. An alternate approach to identifying the classification is to search Health Canada’s MDALL (http://bit.ly/CanadianMDALL) medical device licensing database for a competitor’s equivalent product. If you don’t know the name of competitor products, you can also use Health Canada’s keyword index (http://bit.ly/CanadianKeywordIndex).

Get Health Canada’s Input

Once you have written your classification rationale, then you should email the classification rationale to Health Canada’s licensing division (http://bit.ly/CanadianMDL). Help with identifying the proper device classification in the CMDR does not require paying a consultant thousands of dollars, because Health Canada will not charge you for this service, and they typically respond within 7-10 days. Their response will confirm you have identified the correct classification for your product, or you will receive an explanation of why another rule is a better choice.

Regulatory Pathway Identification

Medical Device Academy offers a standardized service for identifying the regulatory pathway for device submissions to the United States, Europe, and Canada. We recommend that companies prepare a regulatory pathway document during the initial design planning stage (ISO 13485, Clause 7.3.1) because the harmonized standards identified will become your design inputs (ISO 13485, Clause 7.3.2). The Canadian pathway is always the easiest and least expensive of the three markets mentioned.

Do Not Ask Your CMDCAS Registrar

Your company’s ISO 13485 registrar should NOT attempt to participate in the above classification process. Health Canada specifically tells all CMDCAS (http://bit.ly/CMDCAS) auditors to instruct companies to contact Health Canada directly. The CMDCAS auditor is only supposed to verify that the company has a documented licensing process and documented classification rationale. Health Canada’s Device Licensing Division assesses the accuracy of the rationale.

You may also be interested in joining the LinkedIn Group I manage on this topic (i.e.,- CMDCAS): http://bit.ly/CMDCASLinkedInGroup.

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CE Marking Routes to Regulatory Approval

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ce marking routes CE Marking Routes to Regulatory ApprovalReviewing the conformity assessment process contained in Annexes VII, II, V, and III related to seeking CE Marking regulatory approval.

CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier)—regardless of the device classification. However, the classification of the device has a significant impact on the regulatory approval pathways available to your company. Therefore, the first step in the process of CE Marking of medical devices is to determine the risk classification (https://medicaldeviceacademy.com/ce-marking-faqs/). There are four device classifications: Class I, IIa, IIb, and III.

Once your company has determined the risk classification of the device, then you must decide which conformity assessment procedure you will follow to receive CE Marking approval. The conformity assessment procedures available for each classification are identified in Article 11 of the Medical Device Directive (http://bit.ly/M5MDD), and additional detail is provided in the various Annexes (i.e., – Annex II, III, IV, V, VI, and VII). The following table below summarizes the options for each classification:

ce marking chart CE Marking Routes to Regulatory Approval

If your product is a Class I device that is non-sterile and non-measuring, then you will not require a Notified Body (NB). However, all other products will require your company to select a NB (http://bit.ly/SelectingRegistrar).

Annex VII – Declaration of Conformity

If your company does not require NB involvement, then you can issue a Declaration of Conformity In accordance with Annex VII. You must also register your product with one of the Competent Authorities (CA) in Europe. CAs are the U.S. FDA equivalent in each EU member state. The following is a list of contact information for all the CAs: http://bit.ly/ContactPoints. If your company has no physical presence in Europe, you must also select a European Authorized Representative (AR). I recommend selecting an AR who is one of the 15 members of the European Association of Authorized Representatives (http://bit.ly/EAARMembers).

Annex II – Full Quality Assurance

Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity and your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls and that your process for establishing and maintaining a Technical File is sufficient. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the Certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.

Annex V – Production Quality Assurance

The Annex V conformity assessment process is the most common route to CE Marking for companies that outsource product design to a third party. If your company outsources design, Clause 7.3 is excluded from your ISO 13485 Certification, and you cannot demonstrate “Full Quality Assurance.” Therefore, the NB will issue an Annex V certificate for “Production Quality Assurance.” Annex IV and Annex VI are alternate conformity assessment procedures, but these are used less frequently for medical devices and are outside the scope of this blog.

Annex III – Type Examination

The Annex III conformity assessment process is a type of examination that is performed for higher-risk devices where the company does not have an Annex II certificate. This type of examination involves a review of your company’s design dossier, and the NB issues a Type Examination CE Certificate. This Certificate cannot be used alone for CE Marking. Type Examination Certificates must be used in conjunction with another CE Certificate, such as the Annex V certification for Production Quality Assurance. This combination would be used for Class IIb and Class III devices instead of an Annex II CE Certificate.

If your company needs help with CE Marking, including training on the medical device directive, please contact Medical Device Academy at rob@13485cert.com. We are also developing a webinar series for this purpose. If you are interested in more services, try viewing the following blog category page: CE Marking.

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Certification Body Selection

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The author reviews the certification body selection process for ISO 13485 certification, MDSAP Certification, and CE Marking.

Cropped Front of Card Certification Body Selection

What is a Certification Body?

A certification body is a third-party company that is accredited by an organization like the ANSI-ASQ National Accreditation Board (ANAB) or Standards Council of Canada (SCC) to perform certification audits against ISO Standards, such as ISO 9001 or ISO 13485. Accreditation bodies verify the conformity of certification audits to the ISO/IEC 17021 Standard. Some certification bodies are not accredited or may be self-accredited. Still, you will need a certification body that is accredited to meet the regulatory requirements of Health Canada and European Competent Authorities.

Certification body selection for your company is a critical step on the journey toward ISO 13485 certification. When I first joined one of my previous companies, I was assigned the task of implementing ISO 13485 to comply with the Canadian Medical Device Regulations (CMDR) under the Medical Device Single Audit Program (MDSAP). First, I discovered that the company already had two certification bodies. The company initially received an ISO 9001 certificate from one certification body, and then a few years later, an ISO 13485 certificate was issued by another certification body. Unfortunately, neither certification body was recognized by Health Canada. Therefore, when I joined the company, and we were seeking a Canadian Medical Device License, we had to find a third certification body. This time, I selected a registrar recognized by Health Canada. Then I was able to transfer our ISO 9001 certificate to the new registrar and eliminate the other two certification bodies.

When conducting certification body selection, you will find that there are different names for the term, depending on the country to which you are seeking your certificate. For some of the biggest markets, they are named as follows:

  • Europe – notified bodies
  • Canada – registrars
  • Japan – registered certification bodies
  • Australia – conformity assessment bodies

8 Points to Consider When Selecting a Certification Body

  1. Refer to the official Europa page that helps you identify the complete list of “possible” Notified Body candidates based on the product category.
  2. The size and reputation of the notified body can have an impact on your customer’s confidence in your QMS. If they are savvy, they know who the key players are, and who has the more credible reputations in the medical device field. Before transitioning to BSI, I experienced “eye-rolling” during customer audits when asked for the name of our notified body.
  3. Consider the level of risk associated with the classification of the medical devices that are currently marketed and those that may be planned for future distribution. The EU Commission and Competent Authorities (US FDA equivalent in European member states) throughout Europe are currently re-evaluating all the Notified Bodies to determine if they will continue to be allowed to issue CE Design Examination Certificates (Annex II.4) and CE Type Examination Certificates (Annex III) for the highest risk devices (i.e., – Class IIb and Class III).
  4. Identify all your regulatory needs unless you want to contract multiple certification bodies (not recommended). Certification bodies are not created equal, and some may not be qualified to provide all the services needed. A certification body qualified to issue a certificate for ISO 13485 may not be able to provide a CE certificate for CE Marking required by the EU, and only 15 certification bodies are recognized by Health Canada as MDSAP Auditing Organizations. To avoid the need for additional certification bodies in the future, you need to identify your long-term certification requirements for the international markets you will be distributed in.
  5. Compare price quotes from each certification body you are considering and make sure that you provide the same criteria to each potential certification body to ensure that you are getting a fair quote. This is also the time to determine ALL costs associated with audits, certificates, and any other fees. Be sure to include any travel costs, as they are part of the fees that will be included in the contract. If you have multiple sites, consider the benefit of utilizing the same auditor for each site for consistency. However, using one auditor can also incur higher travel costs.
  6. Evaluate each certification body’s customer service before the initial certification audits by asking for “360-degree” evaluations by everyone in your organization that will interact with the certification body directly. This includes planners scheduling the certification audits, the accounts receivable department handling invoices for the certification body, and your sales team that may be able to represent a customer’s opinion of the various certification bodies you are considering. Responsiveness is one of the best criteria to evaluate this customer service against. If the certification body is difficult to work with before certification, it won’t get better.
  7. What is your regulatory strategy? Are you looking for a certification body that will conduct an audit that barely meets requirements? Or maybe you want a certification body that will work with you as a partner to build a QMS made up of best practices. I recommend a “picky” certification body. This will ensure that you choose a partner that forces you to improve your QMS and remain competitive with other medical device companies that have embraced the principles of an ISO QMS.
  8. Finally, if your medical devices or the manufacturing process is complex or innovative, you should select a certification body with auditors that have the technical expertise to understand your product and processes. For example, if your company makes special plastic implants that require “gas plasma,” or vapor-hydrogen peroxide sterilization, you want to ensure that the certification body has auditors that understand this sterilization process.

Strategic Decision-Making

For certification body selection, a spreadsheet may help keep track of information. However, the best practice for making this type of strategic supplier decision is a “Proposal A3 Report”. This special type of A3 Report is explained in Dan Matthew’s workbook. Rob Packard, the founder of the Medical Device Academy, used this approach for the certification body selection of a new Notified Body to transfer to for a recent client.

If you need assistance with ISO 13485 Certification or are interested in training on medical device regulations for the United States, Europe, or Canada, please email the Medical Device Academy at rob@13485cert.com, or contact Rob Packard by phone @ +1.802.258.1881.

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How to write a CE Classification Rationale

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%name How to write a CE Classification RationaleThis article explains how to write a CE classification rationale for medical devices compliant with Annex VIII of the EU MDR.

Note: Blog page is under construction

 CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier). One of the requirements of this technical documentation is to establish the risk class of a device in accordance with the classification rules in Annex IX. The requirement to include this classification rationale in the Technical File is not well defined in Article 9, Classification, of the Medical Device Directive (http://bit.ly/M5MDD), but the guidance document for Technical Documentation (http://bit.ly/NBMED251Rec5) clearly defines this requirement in Section 3.2 (viii). Establishing a classification rationale is the first step to establishing the regulatory pathway that will be required to CE Mark your medical device.

What are the CE Marking device classifications?

There are four different classifications of medical devices in Europe: Class I, Class IIa, Class IIb and Class III. These four classifications are also referred to as “risk class.” The lowest risk classification is Class I, and the highest risk classification is Class III. Class IIa is considered a “medium risk,” while Class IIb is considered a “high risk” medical device. Notified Body involvement and a CE Certificate from the Notified Body is required for almost all medical devices distributed in Europe, however, Class I devices that are non-sterile and do not perform a measurement function do not require Notified Body involvement. Class I devices that are sterile are often referred to as “Class I-S,”but this is not a term used in the Directive. The same is true of “Class I-M” for Class I devices with a measurement function.

Applying the classification rules for medical device CE Marking

In order to apply the classification rules as defined in Annex VIII of the MDR, the following questions must be answered for the device or device family:

  1. Is the device invasive? –  Invasiveness of a device is an important criterion, because non-invasive devices are generally Class I, and there is typically no Notified Body involvement required for these devices.
  2. Is the device surgically invasive, or invasive with respect to body orifices?  If a device is surgically invasive with respect to a body orifice, Rule 5 is the most likely classification rule. For all other devices that are surgically invasive, the duration of use is important
  3. How long is the device used inside the body? The primary difference between Rules 6, 7 and 8 is the duration of use. In general, permanent implants are subject to Rule 8, and are Class IIb devices. The other surgically invasive devices are generally Class IIa devices. Devices under Rule 6 are for “transient” use (i.e., – intended for continuous use for less than 60 minutes). Devices under Rule 7 are for “short-term” use (i.e., – intended for continuous use for between 60 minutes and 30 days.). There are multiple exceptions to each rule, and these exceptions should all be considered.
  4. Is the device electrically powered (i.e., – an active device)? Active devices are subject to rules 9, 10, 11 and 12.
  5. Do any of the “Special Rules” apply? It is recommended to actually start with Rules 13-18 to ensure that one of the special rules do not apply. For example, if you are making blood bags, there is no need to read anything in Annex VIII except Rule 18.

Guidance Document for Classification

Annex IX defines the classification rules for Europe, but there is also a guidance document (http://bit.ly/EUClassification) published that helps to explain the classification rules with examples. This guidance document is extremely important, because it provides clarification of rules based upon interpretations that have been made by Competent Authorities with Notified Bodies and companies. For example, critical anatomical locations are defined in Section 3.1.3: “For the purposes of the Directive 93/42/EEC, ‘central circulatory system’ means the following vessels:…”.

When you write a classification rationale for your technical documentation, it is important to reference this document—as well as Annex IX of the MDD. Your rationale should address each of the questions above for applying the classification rules. In addition, your rationale should indicate that none of the “Special Rules” (Rules 13-18) are applicable to your device or device family.

Mixed Classifications

It is possible to have a device family, contained within one Technical File or Design Dossier, that has more than one Classification. For example, you could choose to group a family of vascular grafts together in one Technical File that are permanent implants and non-absorbable. Normally, these devices would be Class IIb in accordance with Rule 8. However, if one or more of the grafts is intended for vessels included in the central circulatory system, then these grafts would be Class III devices. If a graft can be used for either indication, then the higher classification should be applied.

EU MDR – Regulation (EU) 2017/745

On September 26, 2012, the European Commission released a draft proposal for a new medical device regulation. The expected implementation transition period for these proposed regulations is 2015-2017. In Annex II of the proposed regulations (http://bit.ly/EUProposal), it specifies that the risk class and applicable classification rationale shall be documented in the technical documentation. This appears as item 1.1e) under the heading of “Device description and specification.”

The MDD defines the classification rules for medical devices in Annex IX, while in the proposed EU regulations classification, rules are now in Annex VIII. The MDD also has 18 rules, while the proposed regulations have 21 rules. In order to download a Gap Analysis of the Classification Rules for CE Marking, please visit the following page on this website: http://bit.ly/gapanalysiscmda.

If you need assistance with medical device CE Marking, or you are interested in training on CE Marking, please contact Medical Device Academy at: rob@13485cert.com. Medical Device Academy is developing a webinar series specifically for this purpose. You can also call Rob Packard by phone @ 802.258.1881. For other blogs on the topic of “CE Marking,”please view the following blog category page: http://robertpackard.wpengine.com/category/ce-marking/

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ALARP vs As far as possible – Deviation #3

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This third blog in a seven-part series reviews deviation #3, ALARP vs. “As far as possible,” with regard to risk reduction.

chart dev 3 ALARP vs As far as possible Deviation #3In 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised, but there was no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the 14971 Standard and the requirements of three device directives for Europe. This seven-part blog series reviews each of these changes individually and recommends changes to be made to your current risk management policies and procedure.

Note: This is 2013 blog that will be updated in the near future, but the following link is for our current risk management training.

Risk reduction: “As Far As Possible” (AFAP) vs. “As Low As Reasonably Practicable” (ALARP)

The third deviation is specific to the reduction of risk. Design solutions cannot always eliminate risk. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). However, Essential Requirement 2 requires that risks be reduced “as far as possible.” Therefore, it is not acceptable to only reduce risks with cost-effective solutions. The “ALARP” concept has a legal interpretation, which implies financial considerations. However, the European Directives will not allow financial considerations to override the Essential Requirements for the safety and performance of medical devices. If risk controls are not implemented, the justification for this must be on another basis other than financial.

There are two acceptable reasons for not implementing certain risk controls. First, risk control will not reduce additional risk. For example, if your device already has one alarm to identify a battery failure, a second alarm for the same failure will not reduce further risk. The redundant alarms are often distracting, and too many alarms will result in users ignoring them.

The second acceptable reason for not implementing a risk control is that there is a more effective risk control that cannot be simultaneously implemented. For example, there are multiple ways to anchor orthopedic implants to bone. However, there is only enough real estate to have one fixation element at each location. If a femoral knee implant is already being anchored to the femur with metal posts and bone cement, you cannot also use bone screws at the same location on the femur to anchor the implants in place.

ALARP does not reduce risk “As far as possible”

Annex D.8 in ISO 14971, recommends the ALARP concept in Clause 3.4 of the 14971 Standard. Therefore, the risk management standard is contradicting the MDD. This contradiction is the primary reason why medical device companies should discontinue the use of phthalates and latex for most medical devices. Even though these materials are inexpensive solutions to many engineering challenges presented by medical devices, these materials present risks that can be avoided by using more expensive materials that are not hazardous and do not pose allergic reactions to a large percentage of the population. The use of safer materials is considered “state-of-the-art,” and these materials should be implemented if the residual risks, after implementation of the risk control (i.e., – use of a safer material) are not equal to, or greater than, the risk of the cheaper material.

Recommendation for eliminating ALARP

Your company may have created a risk management procedure that includes a matrix for severity and probability. The matrix is probably color-coded to identify red cells as unacceptable risks, yellow cells that are ALARP, and green cells that are acceptable. To comply with EN ISO 14971:2012, the “yellow zone” should not be labeled as ALARP. A short-term solution is to simply re-label these as high, medium, and low risks. Unfortunately, renaming the categories of risk high, medium, and low will not provide guidance as to whether the residual risk is reduced “as far as possible.”

Resolution to this deviation

As companies become aware of this deviation between the 14971 Standard and the Essential Requirements of the device directives, teams that are working on risk analysis, and people that are performing a gap analysis of their procedures will need to stop using a matrix, like the example above. Instead of claiming that the residual risks are ALARP, your company will need to demonstrate that risks are reduced AFAP, by showing objective evidence that all possible risk control options were considered and implemented. Your procedure or work instruction for performing a risk control option analysis may currently state that you will apply your risk management policy to determine if additional risk controls need to be applied, or if the residual risks are ALARP.

This procedure or work instruction needs to be revised to specify that all risk control options will be implemented unless the risk controls would not reduce risks further, or the risk controls are incompatible with other risk controls. Risk control options should never be ruled out due to cost.

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Effective Management Solutions for 10 CAPA Program Blunders

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The author provides effective management solutions for ten real-life CAPA program blunders., (i.e., procedures, root cause analysis, closing CAPAs, etc.)

%name Effective Management Solutions for 10 CAPA Program Blunders
Effective Management Solutions for 10 CAPA Program Blunders

I am always looking for new and creative ways to help people understand the importance of maintaining an effective Corrective and Preventive Action (CAPA) program. If my last dozen CAPA blogs were not convincing enough, maybe this list of suggestions will help.

  • 1. If someone doesn’t follow procedures, just fire them. The employee in question is obviously the root cause. Management cannot be held responsible for the actions of employees. Once, I read a corrective action plan that indicated termination was the correction for a missing training record. The QA Manager clarified this statement by saying that the employee resigned for personal reasons, and there was no opportunity to train the employee. The CAPA record also indicated that 100% of the training records for manufacturing employees were reviewed for completion. There were a few records identified as incomplete, and those employees were trained—not terminated. The company also implemented a tracking tool to monitor training records. As a general rule, termination is not an acceptable corrective action or correction.
  • 2. If CAPAs are open longer than your procedure allows, close the existing CAPAs the day before the CAPAs become overdue, and open new CAPAs. CAPAs are not “closed” until all nonconformities have been corrected, corrective and preventive actions are implemented, and effectiveness checks are done. If the corrective and preventive actions were not completely effective, some companies chose to reopen the record and expand the plan of corrective and/or preventive actions. Other companies chose to open a new CAPA record, and reference the new record in the effectiveness check section of the previous CAPA record. Either approach works, but you cannot close an incomplete record and remain compliant.
  • 3. To verify the effectiveness of corrective actions, just include a copy of your document change order. Documenting changes to procedures meets part of the CAPA requirements, but this verifies implementation—not effectiveness. To verify the efficacy, you need to confirm that a nonconformity, or a potential nonconformity, will not recur. Low-frequency defects are often hard to demonstrate directly. The best approach is to validate the process parameters to demonstrate quantitatively that the process capability has improved. For manual processes, you may need to test the new process to verify that the error will not occur or will be detected.
  • 4. If you can’t finish tasks on schedule, revise your plan. If you still can’t finish tasks on schedule, revise your plan again—and again. It’s appropriate to revise your plan if you discover additional causes that your initial investigation missed. You should not, however, be revising target completion dates—except in rare cases. You also should not need to revise your plan multiple times.
  • 5. When you’re unsure why a problem occurred, identify the root cause as an unclear procedure, and make a minor change to the appropriate SOP. Making changes to procedures is quick and easy to verify. Unfortunately, this approach is seldom effective in preventing recurrence. You need to develop new process controls to make errors impossible. Eliminate variation in raw materials, eliminate subjectivity in inspections, and provide tools and fixtures to make manual processes capable of more consistent results. After you have reduced all three of these sources for process defects, then you are ready to revise your procedures and retrain employees.
  • 6. Whenever an employee fails to follow a procedure, just change the procedure to require another person to verify that they did it right. If one employee fails to follow procedures 100% of the time, a second person manually inspecting will also not be 100% effective. Another method of process control should be used to ensure that your process results in a conforming product. Adding more people provides a false sense of confidence. The use of objective measurement and go/no go fixtures offer a higher degree of certainty.
  • 7. Write a justification for an extension of the implementation timeline if a CAPA is about to become overdue. Justifications for extension provide objective evidence that management is aware that a CAPA plan is not meeting the target completion times. This is necessary on rare occasions, but extensions should never become routine. Also, if the progress of a CAPA is slow, monitoring should be frequent enough that management can release additional resources, or re-prioritize assignments in order to catch-up with the target completion date.
  • 8. Use the “5 Why” technique for root cause analysis to identify a user error to blame for complaints. The “5 Why” technique is effective at investigating the depth of a problem to ensure that the root cause is identified—instead of a symptom. If the reason for a problem is recognized as a supplier, then it is necessary to ask why the supplier’s error was not prevented or detected. Sometimes this requires asking “Why” more than five times, but identifying a cause you have no control over will fix nothing
  • 9. To monitor your CAPA program, conduct weekly CAPA board meetings where a person is asked to explain why the CAPA they were assigned is overdue. Anyone can make an excuse, but excuses will not complete CAPAs. CAPA boards and weekly meetings can be extremely valuable, but your CAPA board should rely on three rules: 1. Managers need to be present to re-allocate resources and re-prioritize tasks. 2. CAPAs that are on schedule or ahead of schedule requires no further discussion. 3. Anyone assigned to a CAPA that is behind schedule should request help and suggest solutions before the CAPA becoming overdue.
  • 10. Do not assign other departments the responsibility for CAPAs, because only QA has the training and competency to conduct an investigation of the root cause, and write a CAPA plan.  One of the most effective CAPA management tools I observed was a visual communication board that used color-coded paperclips, which identified resources assigned to CAPAs. By limiting the number of paperclips to equal the number of resources allocated to CAPAs, the company was able to level the workload of CAPA assignments to match the available resources in each department. You can only achieve this level of efficiency and effectiveness if multiple people in multiple departments are trained and competent to investigate the root cause and write CAPA plans. CAPA should be a core competency for every department because it’s the best process for fixing and preventing problems.

Disclaimer: If you missed my sarcasm, these are ten ways to mismanage a CAPA program. The brief paragraph after each numbered example is intended to provide the actual recommendation for effective management of your CAPA program.

%name Effective Management Solutions for 10 CAPA Program BlundersIf you are interested in learning more about CAPA, please register for the Medical Device Academy’s CAPA Workshop on October 3 in San Diego. Click here to register for the event: http://bit.ly/MDAWorkshops.

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