Who’s Afraid of the Proposed European Scrutiny Process?

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).

I was looking for a video that matched up with my title and when I saw this TECHNO music video.

The US 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 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 8 August 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 on a regular basis. 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 market for innovative devices is also identified in the “Risk(s) identified” (Section 2.2.1). Therefore, the need for a control mechanism is identified 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.

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New Draft EU Regulations may be speculation now, but the crowd knows a secret.

Right now the precise content of the new draft EU regulation is defined but unclear. We know what is going to change, but the final language of the draft is still a “work in progress.”

Therefore, I am using the theory that the “crowd mind” collectively may be more accurate than any one source–at least until the release. I started gathering information from several different regulatory experts throughout Europe and the US.

Essentially what we know is:

1. this will be a regulation instead of a directive

2. the regulation will have a similar structure of articles and annexes, but we can expect the document to grow

3. the device classification section will be a risk-based classification similar to the GHTF guidance (IVD’s are expected to be A, B, C, D)

4. the requirements for Notified Bodies will be stricter, but we expect rotation of lead auditors–not actual Notified Bodies

5. the unannounced audits will probably resemble factory inspections as performed by other GHTF countries

6. the vigilance requirements and post-market-surveillance are expected to become more consistent between Competent Authorities and between Notified Bodies–including the addition of PMCF Protocols and Reports becoming part of the Technical Documentation required for Design Dossiers (the CMC should help achieve this)

7. there will be new requirements for economic-operators (i.e. – importers and distributors)

8. the Authorized representative agreements will become mandatory for the Technical Documentation as well (see the new MEDDEV from earlier this year…I wrote a blog about it on my 13485cert.com website, but Erik Vollebregt wrote a much more thorough blog on this topic)

9. tougher regulation of reprocessed / re-manufactured devices

10. minimum requirements for CE Certificates–including the addition of the GMDN codes to the certificate

11. implementation is expected in 2015/2016

As I gather more information, I am thinking about just editing this posting–instead of posting a new blog.

Please email me or comment on what information you have learned or what you want to know.

If you know of a website with information posted, please share it and I will add it to this posting.