EMERGO SUMMARY OF KEY POINTS:

• We are now halfway through the transition to the European Medical Devices Directive (MDR).
• Questions regarding issues such as Notified Body designations, Eudamed specifications and Common Specifications remain open.
• Compliance preparations by medical device manufacturers should be well underway by now.

November 26,2018 marks the halfway point in the transitional period for medical device industry to move from the current Medical Devices Directive (MDD) to the new Medical Devices Regulation (EU) 2017/745 (MDR), with a set deadline of May 26, 2020.

The European Commission, Competent Authorities, Notified Bodies and other formal bodies appear busy with this transition. Their progress is reported, although not all is sufficiently clear:

• Notified Bodies are being audited, and in the European Parliament a European Commission official declared that the first designations can be expect by the end of 2018. So far, however, Emergo has not seen any indication confirming this.
• Eudamed is said to be on track, although no specifications have been published yet.
• The Medical Device Coordination Group (MDCG) has been installed and some guidance documents have been published. Still, timely publication of additional guidance would help industry enormously.
• There is no news regarding the expert groups; will they be ready in time?
• It remains unclear what will be published, and when, regarding Common Specifications, implementing acts, guidance documents, etc.

It may appear that the transition period is mainly intended for the European Commission and the Competent Authorities to set up all that is needed for applying the MDR on May 26, 2020, while industry can do their part in the time that is left.

When asked about this specific challenge, representatives of the European Commission and Competent Authorities state that all that is to know, is in the Regulations and anything that should still be needed will be provided before the MDR date of application.

In conclusion, companies should start working on the transition to the MDR now, and be sensible in understanding the requirements from their own perspective. Of course industry associations, stakeholders’ organizations and consultants may help in providing additional guidance and help. However, all involved should be aware that resources are limited all over the field, so it is recommended to plan the transition to MDR with sufficient time left.

Associated European Medical Devices Regulation compliance resources:

• European CE Marking strategy for medical device companies
• European Authorized Representative in-country representation
• On-site European MDR training for manufacturers
• EU MDR 2017/745 gap assessment and transition strategy
• Whitepaper: Understanding Europe’s MDR