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.

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.