Procedure template for ISO ISO 13485:2016 quality systems

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This 12-part procedure template for your medical device QMS can result in writing shorter, more effective documents that facilitate training.%name Procedure template for ISO ISO 13485:2016 quality systems

Procedure Template

We all have a standard template for our quality system procedures. Typically, we begin with purpose, scope, and definitions. This 12-part procedure template for your medical device QMS  can result in shorter, more effective documents that are easier to train personnel on.

1. Purpose. Often I read something like, “This purpose of this document is to describe the CAPA procedure.” That necessary information is the reason why we title procedures. A better statement of purpose would be, “The purpose of this procedure is to provide a process for identifying, preventing and eliminating the causes of an actual or potential nonconformity, and using risk management principles.” The second version gives readers a better indication of the purpose of the procedure.

2. Scope. This section should identify functions or situations that the procedure applies to, but it is even more critical to identify which situations the procedure does not apply to.

3. References and Relationships. Reference documents that apply to the entire quality management system (e.g., – ISO 13485 and 21 CFR 820) only need to be listed in the Quality Manual. This reduces the need for future revisions to the procedures. I list here any procedure-specific external standard (e.g., – ISO 14971) in the applicable procedure. The relationship between procedures is more important than the references. Therefore, I prefer to use a simple flow diagram, with inputs and outputs, similar to the one below for a document control process.

sys 001 Procedure template for ISO ISO 13485:2016 quality systems

4. Document Approval. Who must sign off on the procedure? Keep this list short. Ideally, just the primary process owner and Quality Manager (to ensure consistency and integrity across the quality management system).

5. Revision History. A brief listing of each revision and a brief description of what was changed in the procedure.

6. Responsibilities and Authorities. A listing of the main areas of responsibility for each role. Remember to include the title of managers who may be required to approve forms, or make key decisions.

7. Procedure. I prefer to create a detailed flowchart outlining each step of a process before writing the procedure. Each task box in the flowchart will include a reference number. If you organize the reference numbers in an outline format, then you can write the text of your procedure to match the flowchart—including the numbering of the flowchart task boxes.

example Procedure template for ISO ISO 13485:2016 quality systemscapa Procedure template for ISO ISO 13485:2016 quality systems

8. Monitoring and Measurement. An explanation of how the process is monitored and measured, who does it, how often, format, method of communicating the analysis, and what process that analysis will be input into, e.g., Management Review.

9. Training/Retraining. Tabulated, which roles need to be trained in this procedure, and to what level? The example below is also from a Document Control procedure.role Procedure template for ISO ISO 13485:2016 quality systems

10. Risk Management. This section identifies risks associated with each procedure and how the procedure controls those risks. As well as complying with the requirement to apply risk management throughout product realization (i.e., Clause 7 of ISO 13485), including a section specific to risk management forces the author of the procedure to think of ways the process can fail and to develop ways to avoid failure. Risks can also be a starting point for training people on the procedure.

11. Records. Tabulated, form number and names, a brief description of its purpose, and a column for retention and location. This column also allows for reference to compilations if the record becomes part of, e.g., the Design History File, Device Master Record, or the Risk Management File.

12. Flowcharts. Step-by-step through the process, saying who performs the step when it isn’t apparent. I keep task shapes simple: rectangles for tasks, rounded rectangles for beginnings and endings, diamonds for decision boxes, and off-page reference symbols.

When the task needs supporting text, e.g., guidance or examples, put a number in the box and a corresponding number in the table in (7) above.  Ideally, the flowcharts are placed in the document with the Notes table on the same page or the opposite page. In practice, I often put them at the end to simplify the layout. One of my clients loves her flowcharts and puts them on the front page.

Benefits of this Approach

Information is well structured and presented consistently across procedures, more so than can be achieved through narrative.

  • The flowchart is the primary means of documenting the procedure.
  • Tables provide details that are not clear in the flowchart.

The procedure structure described above facilitates a consistent training approach built around the document. Purpose and scope are presented first, and then the Risk section is presented to explain what is essential in the procedure and why. The flowchart, the table, and the formwork together describe each step of the procedure. Finally, a PowerPoint template can be used to guide process owners in developing their training.

And to make it even easier, you have already spelled out who needs to be trained and to what level.

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What is the IEC 60601 Scope?

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This blog explains the IEC 60601 scope to help you determine if and how IEC 60601-1 applies to your medical electrical equipment.60601 300x274 What is the IEC 60601 Scope?

The first question to ask about IEC 60601 Scope

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery-operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

The title of IEC 60601-1:2005 (3rd edition) is Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The IEC 60601-1 Standard itself states, “This…Standard applies to…MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS…referred to as ME EQUIPMENT and ME SYSTEMS.”

*Note: ALL CAPITAL LETTERS identifies a defined term for the IEC 60601 series of standards within this blog. “IEC” is an acronym for the International Electrotechnical Commission. IEC is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic, and related technologies.

All clause references in this blog are to both IEC 60601-1:2005 (3rd edition) and IEC 60601-1:2005 (3rd edition) + Amendment 1:2012, or the consolidated version IEC 60601-1:2012 (edition 3.1), but the actual text comes from edition 3.1.

Definitions 

The ME EQUIPMENT definition (sub-clause 3.63) is:

“…equipment…

a)    provided with not more than one connection to a particular SUPPLY MAINS, and

b)    intended by its MANUFACTURER to be used:

1)    in the diagnosis, treatment or monitoring of a PATIENT; or

2)    for compensation or alleviation of disease, injury, or disability.”

and “…having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT….”

Note: The above definition aligns well with the description of medical electrical devices in the European Medical Device Regulation.

From the definition above, we know that a device can have up to one power cord, or be hard-wired to the building’s power by one power line, and/or be battery powered.

We also need to understand the term APPLIED PARTS (sub-clause 3.8): “Part of…ME EQUIPMENT…in NORMAL USE necessarily comes into physical contact with the PATIENT for…” the device “…to perform its function.” Classification of the different types of APPLIED PARTS and other classifications (there are eight different classification criteria in the IEC 60601 Standard) need to be completed early in the process of setting up a test plan for design verification to determine the applicable testing requirements, and to develop an appropriate test plan.

Examples within Scope of IEC 60601-1:2005

Examples of electrical medical products fitting the definition above are broad and include battery-operated thermometers, gamma imaging systems, endoscopic cameras, and infusion pumps. IEC 60601-1 may also apply to many ACCESSORIES (sub-clause 3.3) used with ME EQUIPMENT.

Examples not within Scope of IEC 60601-1:2005

The scope of IEC 60601-1 also identifies which devices are not included in the IEC 60601 series:

  • “in vitro-diagnostic equipment…IEC 61010 series;
  • implantable parts of active implantable(s) … ISO 14708 series…;
  • medical gas pipeline systems…ISO 7396-1…”

IEC 60601 & ISO 13485

Design verification must confirm that design outputs (i.e., – product specifications) meet design inputs (e.g., – product must meet IEC 60601-1 requirements).

Many projects don’t identify all the applicable IEC 60601 standards. This could cause multiple nonconformances during an audit by the national regulatory body (i.e., FDA, EU Notified Body), or that you don’t obtain approval to sell and distribute your device from the national regulatory body.

A test plan, with multiple test protocols, is developed from the product specification. This test plan should identify all the requirements of the IEC 60601 series of standards, in addition to any other applicable standards and regulations that apply to the device before performing device testing.

Third-Party Testing

IEC testing can be performed by a third-party test house (i.e., – a safety certification agency, such as a BV, UL, CSA, TÜV SÜD),  an independent test lab (i.e., Medical Equipment Compliance Association), or the manufacturer can conduct the testing if they have the proper equipment, trained personnel and a good understanding (i.e., – used the Standard on several projects, and successfully tested previous similar electrical medical device(s) by a third-party test lab, and been approved by a national regulatory body) of the Standard (s). However, for OSHA compliance in the USA, IEC testing should be performed by an Nationally Recognized Testing Laboratory (NRTL).

Design verification reports generated from the test process are either the applicable IEC 60601, and IEC 80601 series of standards test report forms or the manufacturer’s generated test reports.

The Author

Leo Eisner 2024 What is the IEC 60601 Scope?If your company needs help with IEC 60601-1 gap analysis, preparation of the risk management file for the third edition, or training on the Standard, please contact Leo Eisner (the “60601 Guy”). Leo also created a training webinar series on IEC 60601-1, 3rd edition.

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TGA Joint Registry Report

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Therapeutics Goods Administration (TGA) published an assessment of Australia’s national joint replacement registry report.%name TGA Joint Registry Report

TGA Joint Registry Report

Annually the Therapeutics Goods Administration (TGA) publishes its assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report. This data is crucial to orthopedic companies as a recent source of post-market surveillance for their products and competitors and the development of Post-Market Clinical Follow-up (PMCF) study protocols.

You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.

2013 Annual Report

  • Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages

2013 Supplementary Reports

  1. Analysis of State and Territory Health Data All Arthroplasty – 19 pages
  2. Cement in Hip & Knee Arthroplasty – 15 pages
  3. Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
  4. Demographics and Outcome of Ankle Arthroplasty – 11 pages
  5. Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
  6. Demographics of Hip Arthroplasty – 28 pages
  7. Demographics of Knee Arthroplasty – 23 pages
  8. Demographics of Spinal Disc Arthroplasty – 11 pages
  9. Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
  10. Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
  11. Mortality following Primary Hip and Knee Replacement – 10 pages
  12. Revision of Hip & Knee Arthroplasty – 21 pages
  13. Unispacer Knee Arthroplasty – 6 pages
Post-Market Clinical Data

The requirement to conduct PMCF studies is not new. The release of MEDDEV 2.12/2 rev 2 in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex XIV of EU MDR. It states that “PMCF shall be understood to be a continuous process that updates the clinical evaluation.” 

Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls, and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster, a former Notified Body specialist at TUV SUD, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.”

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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 and a list of which countries require CE marking of medical devices.

You can locate the current list of countries requiring CE Marking of medical devices by visiting the list of Competent Authorities (CAs) on the 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: (https://european-union.europa.eu/principles-countries-history_en). 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 deal includes a rule of origin clause that 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.

A CE certificate is insufficient if your product is manufactured in the US but you do not have a PMA or 510(k) issued by the US FDA. 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 European facility, 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 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, allowing people to pass between countries without 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. 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 most significant 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 an 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 (https://www.linkedin.com/in/medtechamandamaxwell/?originalSubdomain=uk) 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.

The Commission’s press release announced two new documents. The first is regulation for NBs. The regulation is dependent upon four things: 1) the formation of a Medical Device Advisory Committee (MDAC), 2) the formation of a Medical Device Coordination Group (MDCG), 3) the 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 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 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 proposed regulations cost 17.5 Billion Euros. The survey details indicate that implementing 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 Eucamed survey was released 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 about 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 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 the CE Marking of Class IIb and Class III devices 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 won’t happen. To address the public concern related to the PIP scandal (https://www.nhs.uk/conditions/pip-implants/), 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 were 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 implementation costs.

I predict 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 must significantly change supplier quality agreements and technical documentation (i.e., technical file/design Dispenser). You should be drafting a quality plan for implementing 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 inspectionHere is 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 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, the Agency is not obligated 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” (https://medicaldeviceacademy.com/fda-inspection-strategies-that-dont-work/), 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 a 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 are available if the first point of contact cannot be reached. It is reasonable to ask the inspector to return later 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 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 (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual) 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)

Ensure you can escort the inspector to a suitable room with the respective hosts within five minutes of arrival. This will involve ensuring that all administrative staff and critical management clearly understand 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. It 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.

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

Immediately after your inspection room is identified, you must prepare your backroom or “war room.” This room should be located near the inspection room and set up immediately 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, and 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 must arrive at 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, a 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

2 Comments / Health Canada / By

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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