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.
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.
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