ABPI response to MHRA future Medical Device Regulation implementation extension
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance informing industry of a twelve-month extension to the current enforcement date of the future medical device regulations.
It is important that companies have as much certainty as possible about the future regulatory framework in the UK, and the Government should look to finalise these arrangements as soon as possible. David Watson, ABPI Executive Director, Patient Access
The extension will mean industry will have until July 2024 to ensure their medical devices meet the new regulations.
Commenting on the guidance, ABPI Executive Director, Patient Access David Watson said:
“We welcome this extension as it will allow industry more time to make the necessary changes without disruptions to the safe supply of medical devices in the UK.
“The Government now has additional time to finalise the legislation and confirm the transitional arrangements for UKCA marking after July 2024 with further guidance for industry to follow.
“It is important that companies have as much certainty as possible about the future regulatory framework in the UK, and the Government should look to finalise these arrangements as soon as possible.”
Read the MHRA guidance.
- MHRA
Last modified: 20 September 2023
Last reviewed: 20 September 2023
