In this blog post I will try to briefly talk about the implementation of the new European Medical Device Regulation and the implication it has for manufacturers of medical devices operating within the European Union.

The new EU Medical Device Regulation is a legal text that has been publicly preoccupying both the medical device regulatory community and those with medical devices on sale in the European market since its adoption in May 2017.

Since that date, I have been managing the MDlaw Platform. It is a resource hub created by European regulatory experts for manufacturers of medical devices operating or selling within the European union. It is stocked with all the relevant documents and information on the new European medical devices law with the aim of increasing the understanding of MDR 2017/745 and, consequently, allowing manufacturers to become better prepared for the new EU requirements.

For 3 years, I have been closely following the European Commission’s publications (implementing acts, decisions, fact sheets) and optimistic forecasts about its implementation; MedTech Europe’s position papers, often full of concerns expressed by their members; discussions among medical device regulatory experts, with still many open questions, and manufacturers aiming to get ready for May 2021.

It is almost impossible to summarize how to implement the new Regulation – without writing dozens of pages. I will therefore only enlist the most essential actions to take –  before MDR becomes fully applicable (in 12 months!):

  •  Read and re-read the legal text or check one of the e-books;
  •  Review your Quality Management and Risk Management Systems in light of MDR Article 10 and ISO 13485:2016 (manufacturers of Class I devices are not exempted from this requirement!);
  •  Re-asses the portfolio of your devices in view of classification changes and availability of sufficient clinical evidence;
  •  Review your technical documentation for your devices to align them with Annex II and III of the MDR;
  •  Review your clinical evaluation report (CER) in light of MDR Article 61 and Annex XIV;
  •  Implement a UDI system and assign basic UDI-DI to your devices; by 26 May 2021;
  •  Check accreditation status of your Notified Body under the MDR;
  •  Ensure you have a professional Authorised Representative (if based out of EU);
  •  As soon as EUDAMED becomes public, register yourself and obtain a SRN!
  •  Plan the recruitment of a Person Responsible for Regulatory Compliance;
  •  Envisage changes to the labelling, IFUs, promotional materials of your devices;
  •  Comply with post-market surveillance requirements specified in MDR Articles 83-92;
  •  Contract liability insurance;

Ajda Mihelcic Content Manager

DPM of Publications department at Obelis

April 29, 2020

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