MHRA shelters orphaned manufacturers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has moved to offer a degree of protection for companies whose situation has been compromised by the withdrawal of their notified body from the medical device sector at short notice.

In the absence of any specific provisions under the current legislation regarding the ongoing validity of CE certificates in such a scenario, MHRA has acted to ensure that companies are able to continue placing products on the EU market while they search for a new notified body. For eligible companies, this grace period will hopefully provide sufficient breathing space for them to carry on doing business with their EU customers.

Decisions on company eligibility will be made on a case-by-case basis and will be dependent on a number of conditions being met. This includes the company providing regular updates to enable MHRA to monitor progress made in transferring to a new notified body and status of CE certification. MHRA will withdraw permission in the event of a failure to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements.

Manufacturers requiring assistance should contact MHRA (devices.regulatory@mhra.gov.uk).