FDAnews Device Daily Bulletin

MHRA Updates Guidance on UK Notified Bodies

July 24, 2017

Prompted by the United Kingdom’s decision to withdraw from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK.

The MHRA and the European Medicines Agency are very intertwined, so it will be especially difficult for the MHRA to make a clean break, and it’s unclear how the UK regulatory system will work within the EU regulatory scheme as the UK government negotiates the terms of its withdrawal from the EU. 

The standards organization BSI said its role as an EU notified body won’t change following the UK decision to leave the EU. The organization is working closely with the MHRA and the Department of Health to ensure “continuity of our full scope designation” as a notified body for medical devices.