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Focus on Regulation

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”).

The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR will apply from 26 May 2020 and under the IVDR from 26 May 2022. During the transition period, devices can comply with the requirements under either the current EU medical device directives (MDD) or the new Regulations, but not a hybrid of both. After the transition period, devices placed on the market in the EU must comply with the new MDR/IVDR, unless they benefit from the extended CE certificate provisions which allow CE certificates issued within the transition period under the MDD to remain valid for up to four years (MDR) or two years (IVDR) from the date of issue (subject to certain conditions, for example, the certifying notified body must be designated under the new Regulations).

The guide includes:

  • an overview of the transition periods for the application of the new Regulations;
  • examples of the new classification categories of medical devices and in vitro diagnostic devices in the Regulations, as well as of previously unregulated “products without an intended medical purpose” (such as non-corrective contact lenses and brain stimulation equipment), which will be regulated under the MDR;
  • a summary of the classes of devices for which a conformity assessment by a notified body will be required under the Regulations;
  • an overview of the steps that manufacturers must take in order to comply with the MDR/IVDR before placing their device on the market, including assigning a unique device identification (“UDI-DI”) number and entering information in the Eudamed databank;
  • a summary of the obligations that apply to different operators in the medical device supply chain, depending on whether they are a manufacturer, importer, distributor or authorised representative; and
  • an overview of the new, more rigorous post-market surveillance requirements.

The full guidance is available here: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr.