MEDDEV

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

Excuse me. Are you sure this MEDDEV is required Are MEDDEVs Required or Optional for CE Marking of Medical Devices?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.

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

What is a MEDDEV?

The author defines what a MEDDEV is, recent updates, and information resources to learn more.

The most important part of my website is “Helpful Links.” These are the links that I use most in Regulatory Affairs. It started as an auditor’s toolbox, but now I am morphing it into a place to review updates to regulatory requirements and external standards. The MEDDEV’s are on the top of my list. These are the guidance documents written by Competent Authorities. Still, most of the Notified Bodies treat them as requirements and often write nonconformities against at least one of them: MEDDEV 2.12/1 – Medical Device Vigilance System.

Many companies rely on RSS feeds to keep them current on the latest external standards, but this doesn’t work for a MEDDEV. For MEDDEV’s, your best bet is to go to the source. Sure, you can hire a consultant that will try and keep you current. You can also wait until your NB auditor lets you know the hard way (i.e.,. – time to write another administrative CAPA).

For those of you who don’t know the source, it is my #1 “Helpful Link”:

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm 

When asked how to keep current, my advice is to have a systematic process for checking various sources of external documents. At a minimum, you should be checking all of the possible sources just before each Management Review. This will give you something to include for the requirement in clause 5.6.2h) of the ISO 13485:2003 Standard. “More preferably,” as lawyers would say, check out the website link above at least once per month. For those of you that are completely out of touch, and those that just fell off the University hayride, the following explains why you can’t get away with saying:

“There haven’t been any new or revised regulatory requirements since the last Management Review.”

MEDDEV Updates

There were several updates to the MEDDEVs released as supporting documents for the M5 version of the MDD (93/42/EEC as modified by 2007/47/EC). Specifically, there were four in December 2009 and one in June 2010. Then there were two more MEDDEVs released in December 2010 related to clinical study requirements in Europe. In January 2012, another six MEDDEVs were released, and one more was released in March. Not all of these updates apply to every company, but every RA professional working on CE Marked products has been busy readying themselves to sleep at night.

I could spend some time here telling you a couple of sentences about each of these new MEDDEVs, but someone already did that for me:

http://www.eisnersafety.com/eu-medical-device-meddevs-guidance-docs-newly-rlsed-or-updated/#.T8Oml7Dy-So

One fellow blogger indicated that the MEDDEV 2.5/10, about Authorized Representatives (ARs), was disruptive:

http://medicaldeviceslegal.com/2012/02/09/new-meddev-on-authorised-representatives-everything-you-know-is-wrong/

I don’t agree with Erik Vollebregt about it being disruptive. Erik feels that we can all expect substantial revisions in the AR contracts, but I think the Germany AR’s I have worked with were already moving in this direction. Emergo has been a strong AR all along—with a distinctly more friendly Dutch style to their processes. In the end, I just don’t see Notified Bodies (NBs), making these contracts a priority initiative. I think we’ll see more auditors verifying that contracts are in place and current, but I don’t expect auditors to receive guidance on how to review contracts anytime soon.

The real changes will be in the smaller AR’s that are not European Association of Authorized Representatives (EAAR) members. The Competent Authorities (CAs) have been knocking on the door of various “wannabee” AR’s for a few years now. I think they have done an excellent job of shutting down illegitimate representatives, and the member companies of EAAR (http://www.eaarmed.org/) have done well in raising awareness. The next logical step was to provide some guidance so that there is more consistency among the ARs. I see this as just the beginning of the CA’s moving toward one approach.

Erik wrote another article about MEDDEV 2.12/2 on the subject of Post-Market Clinical Follow-up (PMCF):

http://medicaldeviceslegal.com/2012/01/17/new-eu-guidance-on-post-market-clinical-follow-up-studies-published-and-other-meddev-guidance-announced/

Erik just touched on this MEDDEV briefly, but if your company is a manufacturer of a Class III device that is CE Marked—YOU NEED TO READ THIS MEDDEV!

MEDDEV Whitepaper

As in all things post-market related, BSI has taken the lead by publishing an article that is almost as long as the original MEDDEV. This white paper was written by Dr. Hamish Forster, BSI’s Orthopedic & Dental Product Expert, and the document is called “The Post-Market Priority.” I think you can only obtain a copy of this white paper by requesting it from BSI online, but the customer service person that follows up is quite polite.

BSI’s leadership role in PMCF is not new, either. Gert Bos gave a presentation that highlighted the importance of PMCF back on March 31, 2010:

http://www.bsigroup.nl/upload/Presentatie%2031%20maart%20-%20Gert%20Bos.pdf

My advice for anyone that has a Class III device that is CE Marked is to read this MEDDEV a few times, Annex X 1.1c of the MDD, read the whitepaper, and review these presentations by Gert Bos. This will help you prepare for what is coming. For those of you that think you know something about PMCF and have justified why your company doesn’t need to do it, think again. You should review the 16 bullet points in the MEDDEV on pages 14 and 15 (17 bullets in the whitepaper, but one was just split into two parts). Identify how many of these points apply to your Class III device. The more points that apply to your product, the more extensive the NB’s will expect your PMCF plans to be.

 

What is a MEDDEV? Read More »

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