Proposed Medical Device Regulation’s Scrutiny Procedure Onerous for Medtech Industry, Says VollebregtSeptember 26, 2012 – 4:48 pm
Now that the European Commission has published the Medical Devices Directive proposal, I thought I would check in with medicaldeviceslegal.com guru Erik Vollebregt to get his off-the-cuff thoughts. He sees several potential pain points for the device industry but the most onerous, in his opinion, is the so-called scrutiny procedure. “It will delay market entry and increase costs and make the outcome of conformity assessment procedures less predictable. Even if the Notified Body is ready to grant the certificate on solid grounds, the Medical Device Coordination Group (MDCG) may decide otherwise,” notes Vollebregt.
The scrutiny procedure allows the European Commission and member states, acting within the new MDCG committee, to review dossiers for Class III products, explains Vollebregt, adding that the scope may be expanded from time to time for a limited duration.
He describes the process as follows. “First, the Notified Body sends a note to the Commission saying it received an application. This communication includes the draft instructions for use and draft summary of safety and clinical performance and indicates when it plans to sign off on the dossier. The Commission forwards this to the MDCG, which may take a month to decide to request submission of the summary dossier to the MDCG prior to the notified body issuing a certificate. Then the MDCG can take 60 days to review the summary dossier and submit its comments or ask for more information or even a site visit. The Notified Body must give due consideration to any comments received from the MDCG and must explain to the Commission how the comments were taken into consideration—including any rationale for not following the comments—and its final decision regarding the conformity assessment in question.” It’s not an actual PMA as it exists in the United States, adds Vollebregt, but it is a PMA-like procedure. “You can imagine that Notified Bodies will listen to the MDCG comments, even if they are not decisive in terms of the procedure, because they can have their accreditation revoked under the stricter rules for Notified Bodies in the regulation.”
Eucomed has also weighed in on this, calling the move toward a centralised PMA-style system a bad idea that will ultimately harm patients and have a negative impact on small and medium-size companies that make up the bulk of the medical device industry.
“We will need to see if this scrutiny procedure is enough to appease the ENVI committee and, of course, Parliament at large,” says Vollebregt. “The vote for PMA specifically in the ENVI resolution was a narrow one, so I’m keeping my fingers crossed.
“Otherwise I expect some controversy about the new accessory definition, which is so broad that it will suck in a lot of additional software and other products that assist medical devices.”
For more on this, see Vollebregt’s article, New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details, on the medicaldeviceslegal blog.Norbert Sparrow