Phase-in of New Device Regulations Extends Beyond Brexit

UK regulators have outlined the schedule for phasing in new European Union regulations on medical devices — although the UK will no longer be in the EU by the time the regulations take full effect.

The UK triggered the two-year Brexit process on March 29, setting the UK’s departure from the EU for March 29, 2019. Negotiations are ongoing between the UK and EU about the post-Brexit regulatory structure.

The new EU regulations for medical devices and in vitro diagnostic medical devices regulations debuted on May 25, meaning that as of that date, devices can enter the market provided they comply with the new regulations, the UK’s Medicines and Healthcare products Regulatory Agency said.