MDCG Joint Implementation/preparedness plan on MDR

The MDCG just publicly announced that the Actor registration will be available in EUDAMED by May 2020! This means that manufacturers will be for ex. able to receive their SRN. A related guidance shall soon be issued by the MDCG.

The second priority of the MDCG is Placing safe devices on the market after 26 May 2020 in view of  the lack of Notified Bodies’ capacity for certification or the risk of reduced product portfolios. Further guidance will be published on:

  • Application of the transitional period, notably in relation to the interpretation of conditions concerning “significant changes”;
  • How affected manufacturers of some class I devices can make efficient use of the transitional provisions;

There is also a mention of the option that national derogation could be extended temporarily to the whole EU market by the European Commission (allowing safe MDD compliant device with a Certificate that will expire soon after May to stay on the market to avoid shortage of critical devices), as well as related points on Switzerland and Turkey:

  1. An additional factor to be taken into account by stakeholders is the possibility that the EU – Switzerland Mutual Recognition Agreement will not be updated by 26 May 2020. In such case, in order to place products certified by Swiss notified bodies on the EU market, manufacturers will need to have certificates issued by EU notified bodies. For products of Swiss origin or products from third countries having their authorised representative in Switzerland, EU authorised representatives and registration according to the MDR will be required.
  2. An additional uncertainty is the timing of the inclusion of the new Regulations in the customs union agreement with Turkey.

Clinical evaluation and experts panels are listed as the third area of priority and the following shall be published:

  • Guidance on clinical evidence needed for medical devices previously certified under Directives 93/42/EEC and 90/385/EEC (legacy medical devices) and on equivalence for well-established technologies
  • Expert panels established by May 2020.

Priorities and planning are listed in the MDCG Joint Implementation/Preparedness Plan for MDR.

Leave a Reply

Your email address will not be published.