Feb 4, 2020

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new policy whereby British medical device manufacturers may qualify for grace periods as they transfer to new Notified Bodies in order to ensure smoother European market access.

According to an update to its guidance on Notified Bodies and medical device companies, MHRA will provide grace periods on a case-by-case basis to manufacturers either based in the UK, or whose Authorized Representatives are based in the UK, and that hold valid CE Mark certificates under one or more of the current European Medical Devices Directives (MDDs).

How the MHRA grace period will work for qualifying manufacturers

MHRA’s new policy acknowledges significant challenges concerning Notified Body capacity faced by manufacturers seeking to maintain access to European markets during the transition to the Medical Devices Regulation (MDR) in May 2020 (with Brexit adding an additional layer of complexity in terms of necessitating transfers from British to European Union-based Notified Bodies).

Key components and conditions of the regulator’s new policy include:

  • Qualifying manufacturers may continue marketing their devices in the EU until they partner with a new Notified Body;
  • Manufacturers must provide regular updates on efforts to find new Notified Body partners as well as to maintain valid CE Marking;
  • Companies failing to meet MHRA condition, or whose devices fall out of compliance with safety requirements will be disqualified;
  • Obtaining CE Mark certification will formally end the grace period, as the manufacturer in question will no longer fall under MHRA jurisdiction.

No guidance or provisions on how manufacturers should deal with Notified Body withdrawals from the European market exist in the current Directives, prompting MHRA to amend its approach. However, the EU has previously issued its own procedures regarding grace periods for so-called “orphaned devices” in 2017.

Related UK and European medical device regulatory resources from Emergo by UL:

Author

  • Stewart Eisenhart

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