"QP" for Medical Device Manufacturers: Changes in the second Draft of the Regulation

As a result of the PIP scandal the regulatory basis for medical devices is currently being revised. An article from 2012 (QP for manufacturers of medical devices - new EU requirement?) already covered one of the planned changes in the first draft for a EU regulation: The QP for medical devices. The requirements for this person were already listed in § 13 of the first regulation draft. Now there is a second draft that also comprises changes to the "QP for medical devices".

Interestingly, the term "Qualified Person" has been shortened by "qualified" in the second draft of the regulation. However, the draft still comprises qualification requirements, and the scope of activities has even been expanded. According to article 13, medical device manufacturers should have at least one "person responsible for regulatory compliance activities" (so the current name) within their organisation, who is expected to have expert knowledge in the area of medical devices.

Qualification requirements are:
University degree or equivalent degree in natural sciences, medicine, pharmacy, engineering, or other relevant (new: scientific) disciplines and at least two years professional experience in the field of "Regulatory Affairs" or quality management related to "devices" (previously: "medical devices")


five years professional experience in the field of "Regulatory Affairs" (new: related to devices) including (omitted is: or) quality management.

There are exceptions regarding the qualification for manufacturers of custom-made medical devices that now are not generally exempted any more from the obligation to have a "QP". Another new part defines that micro and small enterprises are not supposed to have that person in the company - but they have to have access to such a person permanently and continuously.

In addition to the previously mentioned responsibilities

  • that the technical documentation and the conformity assessment are to be confirmed and kept up to date 
  • that the reporting requirement according to article 61-66 (vigilance) is satisfied 
  • that in clinical trials of medical devices there was a 'statement' to point 4.1 of chapter II of annex 14
    the following part has been slightly modified (changes marked in bold) 
  • that the conformity of the medical device has been checked according to the QM system forming the basis for the manufacture before the product (so far: batch) is released

Entirely new is the responsibility in the second draft of the regulation

  • that the post marketing surveillance obligatiopns are met in accordance with article 8 (7) 

Separate qualification profiles for "QPs" are called for "authorised representatives".

Conclusion: The original "qualified person" person was now renamed in the second draft of the regulation. Perhaps the renaming is supposed to demonstrate a greater difference to the Pharma-QP? The range of tasks has been expanded to post-marketing vigilance activities. The specifications are still just a draft. It will be interesting to see what the actual implementation will look like in the final regulation.
You can find the full text at Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

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