Two more notified bodies – unnamed – have been recommended for designation by the European Commission's Medical Devices Coordination Group (MDCG) under the EU Medical Device Regulation (MDR), Medtech Insight understands from reports of the MDCG's May 20 meeting.
The next step is for a final decision on designation to be taken by the designating authority; this is understood to take between one and two weeks. The notification process is then complete, and the notified bodies’ details are published in the Nando database.
That will bring the number of bodies notified under the new MDR (EU 2017/745) to four, compared with the 58 currently notified under the current Medical Devices Directive.
There is still no indication of when the first body will be designated under the IVDR (EU 2017/746). The IVDR is fully applicable two years after the MDR, on 26 May 2022. Nevertheless, the proportion of companies impacted in a major way by its changes is vast, and this will put an immense pressure on IVD notified bodies - so the sooner they are able to start work the better.
Also, at the 20 June meeting, the MDCG:
Endorsed the Manufacturer Periodic Safety Report (MPSR form).
Endorsed the implant card guidance.
Endorsed the guidance on Person Responsible for Regulatory Compliance (PRRC).
Made good progress on the guidance on Summary of Safety and Clinical Performance (SSCP), with publication foreseen this summer.
The implant card guidance (13 pages long) and PRRC guidance (just five pages long) are now available on the European Commission’s website. The MPSR report form is still awaited.
The implant card guidance makes it clear that the basic implant card design should be simple. The document deals with topics including: legal considerations of the design of the implant card; information to be provided by the manufacturer on the card, and information to be added by the health institution; use of symbols; language requirements; and information on implant cards for implantable systems. It even gives examples for designs of implant cards and leaflets.
The guidance lists the purpose of the implant card as enabling:
The patient to identify the implanted devices and to get access to other information related to the implanted device (e.g. via EUDAMED, and other websites).
Patients to identify themselves as persons requiring special care in relevant situations e.g. security checks.
Emergency clinical staff or first responders, for instance, to be informed about special care/needs for relevant patients in case of emergency situations.
The PRRC guidance, meanwhile, which applies to products covered by the scope of both the MDR and the IVDR, makes it clear that organizations with more than one legal manufacturer under the parent company would need to ensure that each legal manufacturer has its own PRRC.
When it comes to the location of the PRRC, the guidance says that 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 in the EU.
For micro or small enterprises located in the EU, the document also emphasizes that any person permanently and continuously at their disposal should be also located in the EU.
The document also deals with roles and responsibilities of the PRRC within a manufacturer, and within an authorized representative (AR).
More recently, another MDCG document has been published, MDCG 2019-6 Questions and Answers: Requirements Relating to Notified Bodies. The questions include: whether a conformity assessment body (CAB): can provide pre-certification services; accept applications prior to being notified (the short answer is "no"); and what should be the criteria for auditing suppliers and subcontractors.