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Focus on Regulation

MDR and IVDR: the European Commission published some guidance documents

In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The documents which are available on the European Commission website include the following practical guides:

  • Factsheet for manufacturers of medical devices
  • The factsheet is intended to provide a general overview of the consequences of the MDR on medical devices manufacturers.
  • Implementation model: medical devices
  • The document is described as a step by step guide for the implementation of the MDR.
  • Exhaustive list: requirements for medical devices manufacturers
  • The document which was prepared by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on 23 February 2018 includes what is presented as an exhaustive list of requirements applicable to medical devices manufacturers.
  • Factsheet for manufacturers of in-vitro diagnostic medical devices
  • The factsheet is intended to provide a general overview of the consequences of the IVDR on medical devices manufacturers.

For manufacturers which have not yet started to work on their preparation for the new Regulations, the above documents could be really useful as a starting point. For manufacturers which have already started to prepare for the new Regulations, the MHRA list of requirements applicable to manufacturers could constitute a useful checklist to determine if all appropriate requirements have already been considered by the company.

Our team remains available to address any question in relation to these new guides.