New Medical Device Regulations Knowledge Bites Part 3:

How does the new scrutiny procedure look?

The new Medical Device Regulations, whose final drafts were published by the Council of the European Union last week, will result in an additional layer of review of technical documentation for certain manufacturers of medical devices. If you manufacture implantable class III devices (e.g. pacemakers) or class IIb active devices intended to administer and/or remove a medicinal product (e.g. drug delivery systems), you will need to be prepared for two additional layers of review of your technical documentation. The new review procedure will look as follows:

Please see link for original article's diagram

KEY ASPECTS TO NOTE

  • Class D IVDs will be subject to a similar procedure which also involves reference laboratories.
  • The MDCG and Commission can only initiate Step 2 (the scrutiny procedure) if they have "reasonable concerns" in relaton to safety and performance of the device.
  • The NB is only required to give "due consideration" to the EP scientific opinion. If the NB does not follow the advice, it will be required to present a justification.
  • EP scientific opinions and advice will be publically available via Eudamed subject to confidentality.
  • Manufacturers and NB's may pay fees for EP scientific advice. SME discounts will be available.