MHRA to amend Medical Device Regulations

Following the UK’s exit from the EU, the Medicines and Healthcare products Regulatory Agency is to amend the Medical Devices Regulations 2002 and introduce a new regulatory framework. It will extend the scope of regulations to capture certain non-medical products with similar risk profiles to medical devices.

The MHRA says that the new regulations will provide greater assurance on both the performance and safety of the highest-risk medical devices, such as those which need to be implanted.

To signify products have met the new standards, they will carry the UK conformity assessment marking, replacing the CE mark.

In the response to a consultation last year, which asked for views on how devices are assessed before being placed on the market including importer and distributor obligations and post-market safety monitoring, Health Secretary Sajid Javid said:

“I am also determined to eradicate bias, however inadvertent, when it comes to medical devices, and I have appointed Dame Margaret Whitehead to establish the extent of this issue and recommend what action can be taken.”

Engaging with industry and stakeholders, the MHRA plans to gradually phase in new requirements with transitional arrangements to provide enough time to adapt to the changes.