This blog discusses the “scrutiny process” of the proposed EU medical device regulations, whereby authorities can take a 2nd look at audit findings…
For those of you that are not familiar with the “Scrutiny Process,” I am referring specifically to Article 44 of the proposed EU regulations for medical devices. This process is first alluded to at the end of section 3.5 in the “Explanatory Memorandum” (i.e., the 13 pages preceding the proposal for the regulation of medical devices).
The U.S. already has a pre-market approval process that we fondly refer to as the PMA process. In response to the PIP scandal, the European Parliament’s ENVI Committee (Committee on the Environment, Public Health, and Food Safety) proposed a pre-market approval process as part of a press release issued on April 25, 2012. In response to this political pressure, the Commission has proposed a “Scrutiny Process” that involves the preparation of a Notified Body “Summary Evaluation Report,” and verification that the conformity assessment was adequate by the Coordinating Competent Authority.
A similar process is outlined in MEDEV 2.11/1 rev. 2, a guidance document regarding animal tissues, and the Commission Regulation (EU) No 722/2012 of August 8, 2012. The proposed scrutiny process allows competent authorities to take a “second look” and review the findings of the Notified Body that would be issuing a CE Certificate for these high-risk devices. The review process is supposed to be concluded within 60 days, but the review time limit is suspended if the Competent Authorities request additional information or product samples within the first 30 days.
In section 3.5 of the Explanatory Memorandum, the Commission states that this scrutiny process “should be the exception rather than the rule and should follow clear and transparent criteria.” The criteria for invoking the scrutiny process are defined in five points 5a) through 5e) of Article 44. The five points leave room for interpretation by Competent Authorities, and the medical device industry is concerned that the review process for Class IIb and Class III devices will be delayed by at least 60 days regularly. The process could easily be delayed by as much as six months when there are requests for additional information and samples.
The “Legislative Financial Statement” (i.e., – the 19 pages immediately following the proposal for the regulation of medical devices) defines a monitoring process for the scrutiny process in the “Indicator of results and impact” (Section 1.4.4). The risk of delaying access to the market for innovative devices is also identified in the “Risk(s) identified” (Section 2.2.1). Therefore, the need for a control mechanism is recognized in “Control method(s) envisaged” (Section 2.2.2). This will be the responsibility of the Commission to draft a guidance document to define the control method(s). Until industry has an opportunity to review such a guidance document, executives will continue to voice their concerns and apply their own political pressure to the European Parliament.