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Medical Device CE Mark: Is ISO 9001 Certification Required?

For the medical device CE mark: is ISO 9001 certification required? The advantages and dangers of focusing too much on ISO certification are also reviewed.

ISO 9001 is a general quality management system standard, and ISO 9001:2008 is the most recent revision. The focus of that ISO 9001 is customer satisfaction and continual improvement. For medical devices, the applicable international Standard is ISO 13485:2003. This Standard is based upon the ISO 9001 standard, but clauses were added for the specific needs of medical device regulations. Also, the focus of the Standard was changed:

table faq 6 Medical Device CE Mark: Is ISO 9001 Certification Required?

For CE Marking of medical devices, there is a European National version of the Standard: EN ISO 13485:2012 (http://bit.ly/ENISO13485-2012). This is the official harmonized version of the Standard, and certification to EN ISO 13485 presumes compliance with the applicable European New Approach Directives (http://bit.ly/PlenaryVoteBlog). It is not, however, “required” to be ISO certified to either Standard for CE Marking.

If a company chooses not to be certified to a harmonized standard, then the company must:

  1. Be audited to one of the New Approach Directives by their Notified Body, and
  2. Demonstrate how the quality management system they have created complies with the requirements of the applicable Directive(s).

Advantages of ISO certification

The primary advantage of ISO Certification is that your quality system is standardized. Standardization makes it easier for auditors to do their job, and for companies to implement “off-the-shelf” solutions for routine issues that most medical device companies are faced with. Your customers will recognize international standards, and this increases consumer confidence. It has been a considerable benefit to the European Union (EU), because the EU Member States (http://bit.ly/CECountries) have been able to rely heavily upon international standards, instead of having legal debates over nuances between technical Standards developed by each member state.

Another advantage of using harmonized ISO standards is that regulators can establish minimum requirements for all companies. In my experience, the ISO standards are more burdensome for low-risk devices than is probably necessary. However, the ISO standards are often less burdensome for high-risk devices than is perhaps necessary. For the CE Marking process to work effectively, manufacturers must be the experts for their specific device and know when it is required to do more than the minimum. For example, there is an ASTM test specification for cyclic testing of orthopedic implants. Still, recent experience with metal-on-metal (MoM) implants has demonstrated that the ASTM test method is not an adequate predictor of long-term safety and performance. If manufacturers do not develop this expertise, then technical reviews for CE Marking can be quite painful and drawn out as the reviewer is forced to educate the manufacturer on the “State of the Art.”

Dangers of focusing too much upon ISO certification

I find that most medical device company managers are well aware of the ISO 13485 requirements today, but I also believe that many are less aware of the requirements of 21 CFR 820 (http://bit.ly/21CFR820-25) than they were before ISO 13485:2003. Some consulting clients have managers that believe certain regulatory requirements are “just an ISO thing.” It concerns me when the Top Management of a company doesn’t understand basic differences between ISO certification, compliance with 21 CFR 820, and other regulatory requirements. It is the responsibility of the Management Representative to promote awareness of regulatory requirements throughout the organization (i.e., ISO 13485, Clause 5.5.1c). Still, the Management Representative needs the support and commitment of Top Management to promote awareness effectively.

CAPAs, Internal Audits, and Management Reviews are core processes of the ISO 13485 standard. Still, these are also regulatory requirements for the US FDA, Health Canada and CE Marking medical devices in Europe. ISO 13485 Certification, however, is only a mandatory requirement for Canadian Medical Device Licensing (http://bit.ly/FindCMDR). Companies need to focus on the core processes of the quality system and get these right first. In many ways, I would prefer to see companies develop their quality system architecture that best fits their needs. One company I audited did this. Their company has “Leadership Principles.” You can map all of the clauses of ISO 13485 to a specific “Leadership Principle” at that company, but there are requirements included in their principles that exceed the requirements of ISO 13485. If there were no ISO standards, we might see more creative thinking and innovation in the area of quality management systems. Therefore, I encourage every Management Representative to challenge the status quo and to think of ways to improve beyond ISO standards AND meet regulatory requirements.

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EU Mandates Fast-Tracking Changes to the CE Mark Approval Process

EU Parliament is fast-tracking changes to “New Approach” and the CE Mark approval process. Impact of October 22 plenary vote is reviewed and predictions made.

newapproace2.0 EU Mandates Fast Tracking Changes to the CE Mark Approval Process

The “New Approach” was applied to CE Marking of medical devices in the 1990s when member states adopted three “new approach” directives specific to medical devices:

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

The “Old Approach” Directives were extremely detailed. EU member states introduced national standards and regulations faster than the Commission could finalize the “Old Approach” Directives. These national standards and regulations created trade barriers within the EU. Therefore, on May 7, 1985, the European Council resolution was proposed as “a new approach to technical harmonization and standards” (http://bit.ly/CouncilResolution1985).

Basics of the “New Approach”

The “New Approach” Directives (http://bit.ly/EuropaNewApproach) rely heavily upon International Standards, and the Directives are limited to Essential Requirements for Health & Safety. Implementation of the “new approach” directives allows for medical devices to be CE Marked by the manufacturer if the manufacturer completes one of the conformity assessment procedures identified in the applicable Directive.

Typically, Class I devices are self-certified by the manufacturer, while Class IIa, IIb and Class III devices require Notified Body (NB) involvement. Each NB interprets the Directives slightly differently, and the competent authority presiding over each NB audits the NB for compliance with the Directives. These differences are not ideal, but the process enables rapid approval of CE Marking applications because there is no centralized review process—unlike the US FDA.

The Council Resolution of 1985 states that the EU Commission shall review new International standards to determine if the standards are harmonized with the requirements of the applicable Directive (s). If not, the Commission may identify the shortcomings of those standards. A list of the harmonized standards is maintained on the Europa website. The following is a link to the standards harmonized with the MDD: http://bit.ly/ENHarmonizedStandards. For more information about the implementation of the “New Approach,” you can download a guidance document from the Europa website: http://bit.ly/Resolution85.

Politics of the Plenary Vote

Erik Vollebregt (http://bit.ly/ErikVollebregt) wrote an excellent analysis on October 21 (http://bit.ly/10minutestomidnight) about the flaws in the rapporteur’s (http://bit.ly/DagmarRoth-Behrendt) arguments for the draft legislation. In one of his earlier blog postings, however, he predicted that the EP would vote in favor of the draft legislation. Amanda Maxwell (http://bit.ly/AmandaMaxwell) wrote another article in Clinica on October 18 (http://bit.ly/TwoPossibleOutcomes). She predicted two possible outcomes.

The first possible outcome was a mandate from the EP for the rapporteurs to negotiate a final text for the Medical Device Regulations (MDR, http://bit.ly/DraftMedicalDeviceLegislation) with the European Council (i.e., fast-track procedure).

The second possible outcome was a vote of the text as the first reading position of the EP. Due to the European legislative process (http://bit.ly/EULegislativeProcedure), this outcome would result in a delay of final approval of the MDR beyond the April 2014 elections in Europe. On October 12 (http://bit.ly/EMDR-Frankenstein), I stated that I hoped for outright rejection of the draft legislation. Still, I predicted that we would have the worst possible outcome—an EP mandate to negotiate a final text with the Council.

Flawed Interpretations by the EU Commission

Instead of relying heavily upon International Standards, the EU Commission is identifying minor differences between the Directives and the International Standards. In the past, these differences would be resolved when competent authorities issued a guidance document (i.e., MEDDEVs). However, now the Commission is proposing to adopt new Common Technical Specifications (CTS) instead. This provision for adopting a CTS is found in Article 7 of the proposed regulations. The compromise amendments retained the provision in Article 7 for adopting a CTS, but Amendment 7 now indicates that a CTS shall only be adopted when harmonized standards do not exist, are not likely to be adopted within a reasonable period, “have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data.”

The seven deviations identified in the EN ISO 14971:2012 Standard (http://bit.ly/riskblogs) are an example of how the EU Commission is using literal interpretations of the Directives to subjugate the CE Marking process to a corrupted version of the ground-breaking “New Approach.” The details of the EP changes are not yet available, but I suspect Amendment 7 will not change. What is also unclear is if the Commission will continue to insist that International Standards do not meet the letter of the law and therefore are inadequate. It is quite scary to think that politicians and lawyers believe they know better than a committee of international subject matter experts.

An EP Improvement? – New Approach v2.0

The Plenary vote today introduced some new regulations that did not exist in the draft legislation, and the EP mandated negotiation with the Council. Early reactions to the vote were published by Eucomed (http://bit.ly/EPImprovement) and Clinica (http://bit.ly/Clinica-EUFast-Track). These reactions were more positive than I expected, but I fully expect Eucomed to return to its position of criticizing the EP version of regulations before the holidays arrive.

The European Parliament (EP) is rewriting the strategic plan for medical device regulation in Europe. Eliminating the European Medicines Agency from the mix (Article 44a) and replacing it with an “improved” scrutiny process (Article 44, rev 2?) will not substantially accelerate approval of CE Marking applications for high-risk devices. Companies are already frustrated by delays at Notified Bodies and multiple rounds of questions during the review process. The addition of scrutiny by the proposed Medical Device Coordination Group (MDCG), established in Article 78 of the proposal, will increase the costs and delays associated with the CE Marking process. Instead of a streamlined process that allows innovative medical devices to get to market quickly, the EP has created a Frankenstein of regulatory bodies that will result in skyrocketing healthcare costs and bring the flow of innovative devices to a screeching halt.

The EP has mandated that the rapporteurs negotiate a final text with the Council. The EP knows that the member states cannot afford this “stricter” process, and medical device companies cannot afford it either. I predict this will be an ugly political war between the Council and the EP. I also have zero confidence that the EP approach to the MDR will prevent scandals and unsafe products from getting to market. Scandals (http://bit.ly/MHRAReport) and safety issues associated with Metal-on-Metal (MoM) hip implants (http://bit.ly/MoMImplantLessons) are post-market problems—not weaknesses in the CE Marking approval process. I hope that the Council’s counter-proposal to the rapporteurs will be different, but what if it’s worse?

Is anyone interested in learning about Canadian Medical Device Licensing (http://bit.ly/ClassificationforHC)?

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Unannounced Audits: When will your Notified Body’s next audit be?

The author reviews details of the European Commission’s recommendations for medical device auditing by Notified Bodies–including unannounced audits, joint audits of Notified Bodies, and the likelihood of Notified Body mergers.

Were Back 300x146 Unannounced Audits: When will your Notified Body’s next audit be?

On September 25, I posted a blog about the release of the EU Commission’s recommendation on medical device audits and assessments performed by Notified Bodies (http://bit.ly/ENVIVotepasses). You can download the final released version of the recommendation directly from the Official Journal of the European Union (http://bit.ly/ECRecommendation). The most talked-about component of the recommendation is Annex III, which is specific to unannounced audits. I had the pleasure of being invited and attended a TUV SUD.

Training session two weeks ago in Boston (post-RAPS). Hans Heiner Junker (http://bit.ly/Hans-Heiner-Junker) reviewed the recommendation with attendees line-by-line, and there were several items where he said we don’t know what this means, or how this would be implemented. Notified Bodies that are part of Team-NB have met to discuss the interpretation of earlier drafts of the announcement, and each member state is expected to adopt the EC recommendation. For more details about the Team-NB position on the EC recommendation, you can download an article written by Gert Bos of BSI (http://bit.ly/UnannouncedAuditPrep).

Below are the more notable aspects of the EC recommendation.

Annex II – Quality System Assessment

#15 in the list states that “Notified bodies should check the coherence between the quantity of produced or purchased crucial raw material or components approved for the design and the number of finished products.” This recommendation is a direct response to the PIP scandal (http://bit.ly/MHRAReport), but how would an auditor perform a physical inventory during a quality system audit?

At the end of Annex II, the Commission makes recommendations regarding subcontractors. It states that “Notified bodies should refrain from signing arrangements with manufacturers unless they receive access to all critical subcontractors and crucial suppliers and thus to all sites where the devices or its crucial components are produced, regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.” Does your supplier quality agreement have this provision?

If you think the above recommendation is unreasonable, items a, b, c, and d at the end of the section, stretch credibility to the limit. My personal favorite is item (b), “Notified bodies should note that manufacturers…do not fulfill their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system.” If your supplier has confidential processes and trade secrets, your company has no choice but to reference the subcontractor’s documentation. Therefore the requirement to have full technical documentation will need to be addressed by the use of supplier agreements, which allow Notified Bodies access to the Technical Documentation. This requirement will also need to be clarified by the Commission.

Annex III – Unannounced Audit

#1 in the list recommends that unannounced audits shall be conducted once every three years, and more frequently for high-risk devices. The recommendation also states that at least two auditors shall conduct the audits. This represents a 25-50% increase in the number of QMS audit days in a three-year certification cycle. I wonder where Notified Bodies will find 25-50% more auditors to perform these unannounced audits?

This annex includes a requirement that Notified Body contracts with manufacturers would require the manufacturer to inform the Notified Body of the period when devices will not be manufactured. The rationale behind this requirement is so that Notified Bodies will know when they can visit and observe manufacturing actually in progress. However, most Notified Body auditors are scheduled for their audits at least 90 days in advance. Therefore, auditors will have great difficulty ensuring that unannounced audits coincide with the timing of manufacturing lots.

The recommendations also call for unannounced audits of critical suppliers. How will Notified Bodies find the resources to perform these audits when there is already a shortage of qualified auditors?

Notified Body Consolidation is Coming Soon

You may have noticed Notified Bodies are already making a few changes to address the need for qualified auditors:

  1. Unhappy auditors are being lured away from one Notified Body by another
  2. Notified Bodies are using recruiters and advertising open positions with high pay
  3. Sub-contractors are being offered part-time jobs as 3rd party auditors

The compromise amendment 44a to the proposed European Medical Device Regulations (http://bit.ly/EMDR-Frankenstein), creates a new class of Notified Body—the “Special Notified Body” (SNB). This will eliminate the most profitable business for any Notified Body that is not deemed “Special.” This may create an opportunity for larger SNBs to hire the key employees away from smaller Notified Bodies more rapidly.

Competent Authorities have also started performing joint inspections of Notified Bodies this year as a pilot program. There were 11 joint audits performed earlier this year, and eight more are scheduled for the remainder of 2013. As a result of these audits, two Notified Bodies are no longer able to issue new certificates until issues are resolved. This will increase the pressure further for smaller Notified Bodies to merge with larger SNBs.

Will the EC Commission Achieve its Goal?

The EC Commission began pushing for the unannounced audits and increased scrutiny of Notified Bodies in response to the Poly Implant Prosthèse (PIP) breast implants scandal (http://bit.ly/MHRAReport). This was a case of fraud—not neglectful auditing. Some of the solutions proposed by the EC Commission, such as unannounced audits and performing physical inventories, are intended to prevent fraud. In 2014 we will see if these methods are effective. Still, I suspect auditors will remain a step or two behind companies committing fraud, and the only impact will be higher operating costs for medical device manufacturers.

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European Medical Device Regulations: A Bureaucratic Frankenstein

Author reviews details of the latest proposal for medical device CE Marking regulations in Europe–including recommendations and predictions for the plenary vote by the European Parliament.

The Future of Medical Device CE Marking European Medical Device Regulations: A Bureaucratic Frankenstein

Who will approve medical device CE Marking in the future?

Last year we were concerned about the potential for delays caused by the “Scrutiny Process”—Article 44 of the proposed European Medical Device Regulations (EMDR). Two weeks ago, we reported on the vote by the EU Parliament Committee for the Environment, Public Health and Food Safety (ENVI). The EVNI vote was in favor of the compromise amendments to the EMDR. This vote eliminated Article 44 and replaced it with Article 44a. Article 44a is a “case-by-case” assessment procedure for certain high-risk devices.

Comparison of Article 44a with the US FDA’s pre-market approval (PMA) process was made (http://bit.ly/EucomedSep25PressRelease), but the compromise amendment is unique. Three things differentiate the EMDR from any other system used in the World:

  1. Instead of a centralized regulatory authority like the US FDA, CE Marking will continue to use Notified Bodies. Still, we will now have two distinct classes: Regular Notified Bodies and Special Notified Bodies.
  2. The proposed “case-by-case” assessment process will involve the most complicated bureaucratic maze of three and four-letter acronyms in the World:
    1. Medical Device Advisory Committee (MDAC)
    2. Medical Device Coordination Group (MDCG)
    3. Special Notified Bodies (SNBs)
    4. European Medicines Agency (EMA)
    5. Assessment Committee for Medical Devices (ACMD)
  3. This insane process will be expanded to a broader range of devices than just Class III devices:
    • Class III devices,
    • Implantable devices,
    • Devices utilizing non-viable tissues/cells of human/animal origin or their derivatives,
    • Devices incorporating a medicinal, and
    • Devices for delivery of a medicinal.

What Will the Future CE Marking Process Be?

I started to draft a process flow chart for the case-by-case process, but others have already done this, and I have zero confidence that the current draft will be adopted. I hope that the following elements of the compromise proposal are eliminated:

  1. Existence of a Medical Device Advisory Committee (MDAC)
  2. Existence of an Assessment Committee for Medical Devices (ACMD)
  3. Direct Involvement of the Commission in the CE Marking Process
  4. Independent review of CE Marking in parallel with Notified Bodies, special or otherwise

The following elements of the compromise proposal are probably here to stay:

  1. Regular Notified Bodies will no longer be allowed to approve CE Marking of high-risk devices.
  2. High-risk devices will be expanded beyond Class III devices—as indicated above.
  3. The role of the EMA will be expanded to include oversight of Special Notified Bodies.
  4. The proposed MDCG will be created to interpret regulations and recommend changes, but the Commission will control the MDCG.

The following element is missing from the draft legislation: a lack of emphasis on post-market monitoring of device safety and performance. Post-market monitoring is critical because no regulatory process will ever be perfect. Regulators need a mechanism for efficiently identifying unsafe devices that are on the market and removing them quickly.

Predictions for the Plenary Vote on October 22

The Plenary vote by the EU Parliament is the next step of the legislative process. As I stated in my earlier blog (http://bit.ly/ENVIVotepasses), I do not expect a vote in favor of these amendments on October 22. There are currently too many unanswered questions about the details, and the cost will be great for implementing the ill-conceived compromise. European politicians need time to develop a plan for creating each of the new organizations, time to clarify the compromises, and time to quantify the economic impact of implementing the EMDR—especially in a fragile European economy.

The failure to pass accept the draft legislation and send it on to the Council for adoption would be bad. Still, other legal experts (i.e., Erik Vollebregt) believe that the actual situation is worse. In his October 1 blog posting, Erik suggested that Parliament would not amend the draft legislation further and would approve it. This forces the Council to accept the Frankenstein-like compromise that rapporteur Dagmar Roth-Behrendt has facilitated (http://bit.ly/DraftLegislation), or the Council must see past the political circus of the EU Parliament and draft a new proposal that makes sense.

If you want to learn more about the European legislative process, the procedure is explained in the following infogram: http://bit.ly/EULegislativeProcedure. I hope for outright rejection of the draft legislation in the Plenary, but Erik is probably right. Insanity will probably win, and we will be forced to watch in horror as the legislative process proceeds to the European Council.

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What are the Essential Requirements for Medical Device CE Marking?

ER Table1 What are the Essential Requirements for Medical Device CE Marking?

The author reviews the essential requirements for medical device CE marking. Common mistakes to avoid, and the proposed EU regulations are also discussed.

Essential Requirements (ERs) are the requirements for safety and performance specified in Annex I of the three medical device directives. ERs are divided into Part I (i.e., – general requirements) and Part II (i.e., – requirements for design and construction). Evidence of conformity must be provided for all general requirements in Part 1 for all devices—regardless of risk classification, design, or construction. The Design and construction requirements in Part 2 may be not applicable, depending upon your device.

When a Notified Body reviews your Technical File or Design Dossier for CE Marking, the auditor must verify that you have addressed each ER. This is typically demonstrated by providing an ER Checklist (ERC). You can find a template for an ERC on the International Medical Device Regulators Forum (IMDRF) website (http://bit.ly/IMDRFDoc) in Appendix A (see example in Figure 1 below) of the GHTF Guidance document explaining the use of a Summary Technical Document (STED) to demonstrate conformity with the principles of safety and performance (http://bit.ly/GHTFSTEDGuidance).

Figure 1 ERC Example What are the Essential Requirements for Medical Device CE Marking?

Figure 1: Example of an ERC

To demonstrate compliance with the ERs, you must provide the following information by filling in the four columns of the ERC:

  1. Applicability to your device,
  2. The method used to demonstrate conformity with the ER,
  3. Reference to the method(s) used, and
  4. Reference to the supporting controlled documents.
Subparts & Common Mistakes

Completing the ERC would be easy if there were only 13 ERs, but eight of the 13 ERs have multiple requirements. For example, ER 13.3 has 14 subparts (i.e., – 13.3a through 13.3n). Each subpart must be addressed when you complete the columns of the ERC table. If any of the parts in ER 7-13 do not apply to your device, you need to provide a justification. For example, ER 11 and its subparts do not apply to devices that do not emit radiation. This justification must be documented in the ERC for each subpart.

When you write your justification for the non-applicability of an ER, you need to be careful to provide a justification for each part of the requirement. For example, there are three sub-parts to ER 7.5. Each part is a separate paragraph, but these are not identified by a letter, as is done in ER 13.3 and 13.6. Instead, each subpart is a separate paragraph. Within those paragraphs, there is further room for confusion. For example, the third paragraph states that if you use Phthalates in a product that is intended for women or children, then you must provide a justification for its use in the technical documentation, in the instructions for use, within information on the residual risks for these patient groups (i.e., –women and children) and, if applicable, on appropriate precautionary measures.

Proposed EU Regulations

The proposed EU Medical Device Regulations (MDR) are organized into Articles and Annexes–just like the current EU Directives, and the ERs will still be the first Annex of the MDR. However, there will be 19 ERs instead of 13. The early reviews of the proposed regulations indicated that there were no significant changes. Still, I have learned the hard way that you should always go to the source and verify the information for yourself. The general organization of the Essential Requirements is still the same. Nevertheless, several significant changes will require providing additional documentation in your Technical File or Design Dossier for CE Marking. Most companies will probably submit a revised ERC to address the new requirements, but you may want to read Medical Device Academy’s review of the new ERs (http://bit.ly/NewERCGap) and prepare accordingly.

Essential Principles Checklists

Health Canada has an Essential Principles checklist (EPC) that is similar to the European ERC, and Australia has a similar document (http://bit.ly/EPCTGA) with only a few minor differences. The Global Harmonized Task Force (GHTF) created an earlier version in 2005 (http://bit.ly/EPSafetyPerf). Health Canada will typically accept your ERC developed for the European Medical Device Directive (MDD), but a gap analysis should be performed against the Australian Regulations.

Now that the ENVI vote has passed (http://bit.ly/ENVIVotepasses), I asked a new consultant working for me to create a template for the new Essential Requirements in the new EU MDR regulations. You can download the MDD ERC Template and the new EU MDR Template. This new template also indicates the items that were recently modified (see the red lines).

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Which Countries Require CE Marking of Medical Devices?

 

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

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

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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CE Marking Routes to Regulatory Approval

ce marking routes CE Marking Routes to Regulatory ApprovalThe author reviews the conformity assessment process contained in Annexes VII, II, V, and III related to a company 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 (http://bit.ly/riskclass). 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 determine 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 will be able to issue a Declaration of Conformity In accordance with Annex VII. You will also need to 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 does not have a physical presence in Europe, you will also need to select a European Authorized Representative (AR). My recommendation is to select an AR that 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 also reviews 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 adequate. 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 in place 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 interested in more services, try viewing the following blog category page: http://bit.ly/CEMarking.

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Medical Device CE Marking: Writing a Classification Rationale

%name Medical Device CE Marking: Writing a Classification RationaleThe author reviews considerations in “how to” write a classification rationale for medical device CE marking (i.e., questions for applying classification rules).

 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 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 Rules for Medical Device CE Marking

In order to apply the classification rules as defined in Annex IX of the MDD, 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 IX 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 systemmeans 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.

Proposed EU Regulations

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 VII. 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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