13485cert

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

In Authorized Representative, CE Mark, Recast on September 14, 2012 at 4:41 pm

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.

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