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European Commission publishes two guidance documents for MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has just released two MDR guidance documents covering the subjects of Article 15, on the ‘Person Responsible for Regulatory Compliance’ (PRRC), and Article 18 on ‘Implant Cards’.

The documents are available from the following links:

  • MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)
  • MDCG 2019-8 Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Interestingly, the guidance on the PRRC conflicts with the advice proposed in a UK MHRA draft guidance circulated in March 2019. Although not officially released, the MHRA draft advises:

“Can the PRRC be located outside the EU?
There is nothing in the Regulation obliging that PRRC [has] to be established in the EU as long as the two part[ie]s have an appropriate contract in place.”

Whereas the Commission document advises:

“Can the PRRC be located outside the EU? As to the location of the PRRC, it is important that a close linkage, of a permanent and continuous nature, is established between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the EU, it must be assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers located in the EU, it must be assumed that the PRRC should also be located in the EU.”

We wait to see if the MHRA guidance on this topic changes between the draft and final versions, or whether the Commission guidance has over-stepped the legal boundary by including a requirement in the guidance that is not in the regulation.

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