Medicines and Healthcare products Regulatory Agency

MHRA publishes guide to new EU medical device laws

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an introductory guide for manufacturers to make sure their medical devices meet new European Union (EU) legislation.

The guide, designed as an , concerns new EU laws which will apply to medical devices, including digital devices, which are due to be introduced in May 2020. The guide also applies to changes in the law which will affect in vitro diagnostic devises from May 2022.

“We live in an increasingly digital world, and the way we provide our guidance is changing,” said John Wilkinson, MHRA’s director of medical devices.

“We want to help manufacturers to comply with the new regulations as easily and as early as possible.”

Under the new regulations, some products which have previously escaped regulation now fall under the EU legislation. These include dermal fillers, non-corrective lenses and brain stimulation devices.

The interactive document produced by the UK’s medicines safety watchdog is intended to support new and experienced manufacturers alike. The three- and five-year transition periods for implementing the changes are already underway having started on 25 May 2017.

The EU changes include making the supply chain more transparent and the introduction of a unique device identification (UDI) system and new standards for clinical evidence.

More rigorous reporting requirements, including new deadlines, are also being introduced and manufacturers will be given a clearer idea of their post-marketing surveillance responsibilities.

Citation: The Salvadore DOI: 10.1211/PJ.2017.20203476

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