UK’s MHRA Issues Guidance on How to Comply With EU MDR

October 26, 2018

Some medical devices that don’t have an intended medical purpose — such as non-prescription colored contact lenses — will be required to comply with the EU’s new regulations for medical devices by May 26, 2020, the UK’s Medicines and Healthcare products Regulatory Agency said in a new guidance on Annex XVI of the EU’s Medical Device Regulation.

Devices on the Annex XVI list are similar to medical devices but the manufacturer claims only an aesthetic or other non-medical purpose.

The groups of products were included in the new regulation to “introduce requirements around the manufacturing and surveillance of these previously unregulated products to protect the health and safety of users,” the agency said.

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