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Volume: 4 Issue: 9
(September 2017)

mhr issues guidance assist firms mdr ivdr regulation compliance uk medicines healthcare products regulatory agency (‘mhr published 29 august


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MHRA issues guidance to assist firms with MDR and IVDR regulation compliance

The UK Medicines and Healthcare products Regulatory Agency (‘MHRA’) published on 29 August 2017 guidance on the new EU Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746) (collectively, ‘the Regulations’), in order to assist medical device and in vitro device manufacturers in understanding their obligations under the Regulations. The MHRA’s guidance includes an interactive introduction to the Regulations.

The Regulations entered into force on 25 May 2017, with the transition periods until full application to last until 26 May 2020 and 26 May 2022 respectively. The MHRA notes that most requirements under the Regulations will not apply until the Regulations apply fully, and also explains that during the transition period, devices can be placed on the market under the current EU directives or under the new Regulations if they fully comply.

The MHRA makes a number of recommendations to manufacturers, for example on the need to ensure that the increased requirements for clinical evidence found in both regulations are met, as well as ensuring that requirements are met in terms of general safety and performance, for example in regards to labeling. Further, it emphasises the new requirements for IVD manufacturers, which include a requirement for manufacturers to produce more performance evidence and to keep such evidence updated throughout the device’s lifecycle, and changes to classification rules, which will result in notified bodies having to conduct a conformity assessment on between 80 and 90% of IVDs.

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