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Are MEDDEVs Required or Optional for CE Marking of Medical Devices?

Posted by Rob Packard on April 8, 2014

This blog answers the question of whether compliance with MEDDEV guidance documents is required or optional for CE marking of medical devices.

MEDDEVs are guidance documents (http://bit.ly/Whats-a-MEDDEV) written by competent authorities—not law. As it states on the Europa website (http://bit.ly/MEDDEV), “The guidelines are not legally binding.” However, the Competent Authorities (http://bit.ly/ContactPoints) take an active role in developing these guidance documents. Therefore, enforcement of the guidance documents by Notified Bodies depends upon which competent authorities helped to develop the specific MEDDEV. MHRA. For example, is the competent authority for the United Kingdom (UK). MHRA has taken an active role in developing many of the MEDDEVs. Therefore any manufacturer that uses a Notified Body in the UK is more likely to consider the MEDDEVs that MHRA helped create to be “required” rather than “recommended”. The following Notified Bodies are under the jurisdiction of MHRA, but each member states’ competent authority has Notified Bodies that could be affected, including:

British Standards Institute (BSI) – NB # 0086
Lloyd’s Register Quality Assurance (LRQA) – NB # 0088
SGS United Kingdom Limited (SGS) – NB # 0120
AMTAC Certification Services – NB # 0473
UL International (UK) LTD – NB # 0843

There are 32 MEDDEVs divided into 15 categories. The most recent revision to a MEDDEV was in January 2013 when MEDDEV 2.12/1, Medical Device Vigilance System, was updated. This particular MEDDEV is the European equivalent to 21 CFR 803 for Medical Device Reporting, but reporting of adverse events is called “vigilance” in the EU. It is essential to keep current with changes to MEDDEVs (http://bit.ly/New-Revised-EU-Regulations) because Competent Authorities require vigilance reporting using the most current version of the MEDDEV form. In the case of the vigilance MEDDEV, the guidance is de facto law. However, the French Competent Authority recently indicated that trend reporting requirements will be required in the future for high-risk devices, and the French Competent Authority refused to accept the form associated with MEDDEV 2.12/1. Instead, France has its form that is preferred for vigilance submissions.

MEDDEV Enforcement

Other MEDDEVs are not as consistently enforced. For example, MEDDEV 2.5/10 (http://bit.ly/ECREPMEDDEV) provides guidance with regard to the roles and responsibilities of European Authorized Representatives. In some cases, Competent Authorities audit Authorized Representatives for compliance with this MEDDEV. Notified Bodies are also auditing agreements between manufacturers and Authorized Representatives. Unfortunately, many manufacturers still rely upon European distributors that are not compliant with MEDDEV 2.5/10, and Notified Body auditors are merely verifying that an Authorized Representative agreement exists.

Another example of inconsistencies between Notified Bodies is demonstrated by how MEDDEV 2.7/1 (http://bit.ly/ER6aMEDDEV) is enforced. This document guides manufacturers on how to perform clinical evaluations. Some Notified Bodies, especially the Notified Bodies under MHRA’s jurisdiction (see the list above), are systematically reviewing the content of clinical evaluations against the MEDDEV guidance. However, other Notified Bodies continue to verify only that a clinical evaluation exists. Differences between Notified Bodies in how they enforce this MEDDEV is less pronounced for Class III devices, where clinical studies are expected. However, this may be due to the lack of clinical expertise at some Notified Bodies.

The European Commission began a pilot program in 2013 for conducting joint audits by Competent Authorities of Notified Bodies to ensure that there is consistency between the Notified Bodies, and how the Competent Authorities enforce regulations (http://bit.ly/Europa-press-release-24-9-2013). Some of the other changes, such as conducting unannounced audits of manufacturers and their supply chains, are being implemented this year (http://bit.ly/Unannounced-Audits).

Due to the ongoing debate between the European Council and the European Parliament over the draft of the proposed European Medical Device Regulations (http://bitly.com/EMDR-Frankenstein), the issuance of new and revised MEDDEVs has essentially stopped. When the European Medical Device Regulations (EMDR) are finally approved, the medical device industry can expect to see the content of the MEDDEV guidance documents to be superseded by new requirements in the EMDR.

Tags: CE marking of medical devices, MEDDEV

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How to Identify New and Revised European Medical Device Regulations

Posted by Rob Packard on February 11, 2014

This blog offers tips and information for locating the latest European medical device regulations for your next management review meeting.

There are two primary websites to check for new and revised European Medical Device Regulations. The first location is the Europa website, where the three “New Approach” directives and proposed European Medical Device Regulations (EMDR) can be found. There is also a webpage on the Europa website for guidance documents. The following website is managed by Team-NB–a group of Notified Bodies.

Europa Website for Locating European Medical Device Regulations

When you check the Europa website for new and revised medical device regulations, the three most important pages to check are:

http://bit.ly/EUrevisions – On-going revision of the medical device directives.
http://bit.ly/EU-current-legislation – Current medical device directives
http://bit.ly/MEDDEV – Guidance MEDDEVs

The first page provides periodic updates on the status of the proposed EMDR. The most recent update on this page was September 26, 2012. If you are following this carefully, and you understand the European legislative process, then you know that there was a vote by the ENVI committee reviewing the EU Commission’s proposal in September 2013. You also would know that the Plenary Vote on the proposal occurred in October 2013. Now, the European Parliament has mandated that the rapporteurs negotiate a final text with the Council–which is going slower than Parliament would like.

The second page has the current legislation. It is not always obvious if amendments have been made. Therefore, you need to review each of the directives to see if it is applicable. The last significant change to the MDD was the M5 version on March 21, 2010 (i.e., amendment 2007/47/EC to 93/42/EEC). There was a commission implementing regulation on September 4, 2013. Two amendments were released in 2012: 1) electronic instructions for use, and 2) medical devices manufactured with tissues of animal origin.

Finally, the third page lists each of the guidance MEDDEV documents. This list also identifies the date of the most recent version for each MEDDEV. The most recent change was to the vigilance reporting guidance document in January 2013.

Team-NB Website

The website for Team-NB is http://bit.ly/Team-NB. On the home page, there is a navigation bar listing archived documents by year. In 2012, there were nine documents released. Several of these documents are related to the PIP Scandal (http://bit.ly/MHRAReport), which is now old news, but there was one guidance document discussing the transition plans for IEC 60601-1. There were another 12 documents released in 2013. The four most recent documents are confidentiality statements, and five are auditor attestations. Therefore, there are only three new documents of importance to manufacturers:

http://bit.ly/Team-NB-eIFU – guidance on the implementation of electronic Instructions For Use (eIFU)
http://bit.ly/CoCNBV3 – 3rd version of the Notified Body Code of Conduct
http://bit.ly/Team-NB-IEC62304 – FAQs for the implementation of EN 62304

The first document explains two positions from Team-NB. The first position identifies labeling requirements and the use of harmonized symbols for companies implementing eIFUs. The second position indicates that implementation of eIFUs is considered a significant change in the QMS that requires:

Notified Body notification before implementation, and
a list of documents needed by Notified Bodies as objective evidence of readiness for implementation.

The code of conduct includes important details about how the Notified Bodies plan to change the auditing process and qualification of certification auditors to address concerns of the European Council. This includes specific interpretations as to the duration of audits, the duration of an initial Design Dossier review, and the initial plan for unannounced audits by Notified Bodies.

The third document contains 73 frequently asked questions and the response to these questions by Team-NB. There are also four annexes. The 73 questions are organized into the following seven sections:

Scope of EN 62304
Placing Software as a MEDICAL DEVICE on the Market
Life-cycle Processes
Risk Assessment and Risk Management
Classification and Segregation
Specifications, Testing, and Tools
SOUP and Legacy Software

Next Steps

Review each source of information and determine if the document impacts your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

initiate specific changes to existing procedures
create new procedures, or
initiate a quality plan for more substantial changes to your quality system

If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review slide deck.

Tags: european medical device regulations, new european medical device regulations, revised european medical device regulations

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How Declaration of Conformity (DoC) templates are created

Posted by Rob Packard on January 15, 2014

This article about the declaration of conformity for medical device CE Marking identifies three possible sources for creating a template and includes recommendations for making the transition to the proposed EU Medical Device Regulation (EMDR).

Current declaration of conformity requirements

Each of the three “New Approach” Device Directives requires that manufacturers create a Declaration of Conformity (DoC). For the Medical Device Directive (MDD), this requirement is found in Annex II, IV, V, VI, and VII. The “Declaration of Conformity” is part of the title for each of those Annexes. A DoC is required for each CE Marked product family, but the MDD does not guide the format or content. Manufacturers need a controlled template.

Three sources of declaration of conformity examples

There are three possible sources for creating a declaration of conformity template:

Copy another company’s declaration of conformity
Authorized Representatives
Annex III of the proposed European Medical Device Regulations

Most companies are using option number 1—often without knowing it. The problem with this approach is you have no regulatory reference to justify the basis for the content and format of your Declaration.

The second option is to ask your Authorized Representative (AR). The AR is supposed to verify that you have a DoC for each product family and that the company has the required technical documentation for each product family. The AR must provide a DoC for each product they represent to the Competent Authority upon request. Therefore, some ARs provide manufacturers with a template for the DoC to ensure that your DoC meets requirements. This approach gives you a reference of external origin, and you can be sure that the template will meet current requirements.

My new recommendation for Creating A declaration of conformity

Option 3 is my new recommendation for companies. The proposed European Medical Device Regulation (EMDR) was released on September 26, 2012. The proposal provides a prescriptive template for the content of a DoC. This will eventually be required for every DoC. Annex III is only one page long, and there are only ten requirements:

Name of the Manufacturer and the AR
A declaration that DoC Issued under Sole Responsibility of Manufacturer
Unique Device Identifier (UDI)
Product Name and Catalog Numbers
Risk Classification
Declaration Statement of Conformity
Reference to Harmonized Standards and Common Technical Specifications (CTS)
Notified Body Name and Number, Description of Conformity Assessment Procedure and Certificate
Additional Information
Place and Date of Issue, along with the Name and Function of the Person Signing

Instead of waiting for the final approval of the EMDR, I recommend creating a declaration of conformity (DoC) template now that matches the proposed Annex III (you might want to add this to recommendations for improvement in your next management review).

Brigid Glass is the subject matter expert behind most of the conventions that our consulting firm uses for document templates. As with all of our forms, we assign a document control number (e.g., FRM-001), and the revision is “D1” for the first draft. The template is in table format to facilitate easier review by auditors and your AR. The left column of the table lists each of the required elements, and the right column is where the variable data is entered. Variable fields that are examples are in green font, and the content that does not require changing is in black font. There are some comments to explain how to fill in the variable content, and several items that will change when the proposed regulation is approved are identified. The following harmonized symbols from ISO 15233-1 are used in the template, as well:

Please click here to download the Medical Device Academy’s declaration of conformity (DoC) template.

Tags: CE marking, declaration of conformity for medical devices, declaration of conformity for medical devices template, how to create a declaration of conformity for medical devices

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CE marking 4 digit number for medical devices

Posted by Rob Packard on November 24, 2013

This article explains the purpose and use of a CE marking four-digit number for medical devices, minimum size requirements, and other considerations.

CE marking a four-digit number

The CE marking four-digit number that is displayed next to the CE mark on some medical devices is the Notified Body (NB) number. If there is no CE marking four-digit number, this means that the medical device is a Class I device that does not require NB involvement (i.e., self-declaration). If the device is a Class I device, and there is an NB number next to the CE mark, then the device either has a measuring function or is sterile.

Requirements for CE marking a four-digit number

The Medical Device Directive is divided into Articles and Annexes. Section 1 of Article 16 indicates that the European Commission is responsible for the assignment of NB numbers. In Article 17, ¨CE Marking,¨ it states: ¨[The CE] shall be accompanied by the identification number of the notified body responsible for the implementation of the procedures set out in Annexes II, IV, V, and VI.¨ Annex XII defines the minimum size (i.e., 5 mm) of the CE. The requirements for the size of the NB identification number is not included in Annex XII, but NBs interpret the requirements for size as half the height of the ¨CE.¨

Companies are responsible for reproducing the CE Mark on their labeling and the product–including the 4-digit number. However, if the space available on the product is too small to allow a 5 mm ¨CE,¨, then the company is not required to reproduce it on the product. Instead, it is sufficient to reproduce the CE Mark on product labeling and the Instructions For Use (IFU). One source of the artwork for the ¨C¨ and ¨E¨ is the Europa website.

If an NB number is required, usually, there are a couple of different orientations that are allowed by the NB. Most NBs specify that the NB number shall be to the right or beneath the “C” and “E.” However, most NBs have specific instructions available for the reproduction of the CE Mark and the proper orientation of their NB number. Often, the NB will also provide artwork for downloading that includes the NB number in one or more orientation.

Product Failure Investigations

Identification of the NB may not seem important; however, the NB number can help caregivers to identify the NB that approved CE Marking of a product when there is an investigation of product failures with an unknown manufacturer. In that case, the NB will then share this information with the appropriate manufacturer to facilitate an investigation. The NB number is also used to differentiate when the oversight by one NB stops, and a new one begins, after transferring from one NB to another.

If someone wants to know which NB is associated with each NB number, the EU Commission operates the NANDO information system as a database, allowing you to search each of the 60+ NBs by CE marking 4 digit number. The database also allows searching by country, annex/article, product, and horizontal technical competence.

If your company is selecting an NB, you can search the product and technical competency categories to identify which NBs are able to issue CE certificates for your product. There are ten possible technical competencies to use as search criteria. For example, if your company manufactures absorbable sutures (i.e., competency, MDS 7009), there are only 32 NBs (shrinking every day) that have the technical competence to assess your Design Dossier for conformity with the MDD.

If your company is developing porcine-based collagen implants (i.e., competency, MDS 7010), then there are only 24 NBs (shrinking every day) able to issue a Design Examination Certificate for CE Marking. If your company needs additional guidance on how to select an NB, you might consider reading a blog on certification body selection.

Tags: CE Marking for medical devices, CE marking for medical devices-4 digit number, Notified Body

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Medical Device CE Mark: Is ISO 9001 Certification Required?

Posted by Rob Packard on November 2, 2013

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:

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:

Be audited to one of the New Approach Directives by their Notified Body, and
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.

Tags: CE Marking for medical devices, ISO 9001, ISO 9001 certification, medical device CE mark: is ISO 9001 certification required?

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

Posted by Rob Packard on October 23, 2013

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.

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:

Medical Device Directive, 93/42/EEC (http://bit.ly/M5MDD),
Active Implantable Medical Devices Directive, 90/385/EEC (http://bit.ly/AIMDDirective), and
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)?

Tags: CE mark approval, CE marking, european proposed medical device regulations, medical device regulations

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

Posted by Rob Packard on October 19, 2013

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.

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:

Unhappy auditors are being lured away from one Notified Body by another
Notified Bodies are using recruiters and advertising open positions with high pay
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

Posted by Rob Packard on October 12, 2013

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:

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.
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)
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:

Existence of a Medical Device Advisory Committee (MDAC)
Existence of an Assessment Committee for Medical Devices (ACMD)
Direct Involvement of the Commission in the CE Marking Process
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:

Regular Notified Bodies will no longer be allowed to approve CE Marking of high-risk devices.
High-risk devices will be expanded beyond Class III devices—as indicated above.
The role of the EMA will be expanded to include oversight of Special Notified Bodies.
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?

Posted by Rob Packard on October 5, 2013

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: 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:

Applicability to your device,
The method used to demonstrate conformity with the ER,
Reference to the method(s) used, and
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).

Tags: CE marking, Essential Requirements, essential requirements for medical device CE marking, Medical Device

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Which Countries Require CE Marking of Medical Devices?

Posted by Rob Packard on September 27, 2013

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.

Iceland
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 25^th 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.

Liechtenstein
Norway
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.

Austria (1995)
Belgium (1952)
Bulgaria (2007)
Croatia (2013)
Cyprus (2004)
Czech Republic (2004)
Denmark (1973)
Estonia (2004)
Finland (1995)
France (1952)
Germany (1952)
Greece (1981)
Hungary (2004)
Ireland (1973)
Italy (1952)
Latvia (2004)
Lithuania (2004)
Luxembourg (1952)
Malta (2004)
Netherlands (1952)
Poland (2004)
Portugal (1986)
Romania (2007)
Slovakia (2004)
Slovenia (2004)
Spain (1986)
Sweden (1995)
United Kingdom (1973)

Tags: CE Mark, CE marking, medical devices, which countries require CE marking of medical devices

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