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Membership NewsMembership News Archive

MHRA has published their response to the ‘future regulation of medical devices in the UK’ consultation

On 26 June, MHRA published their formal response to the consultation on the future regulation of medical devices in the United Kingdom. This has been eagerly anticipated and gives a lot of detail on what can be expected for the new regulatory framework. The document totals 155 pages and has 16 chapters. An executive summary drafted by BIVDA can be…
Ben Kemp
July 1, 2022
Membership NewsMembership News Archive

Update on MHRA restructuring and BIVDA engagement

As many members will know, MHRA has been undergoing a re-structuring to bring all elements of healthcare regulation together. But meanwhile they have lost critical IVD expertise with recent moves by Graeme Tonbridge, Mike Messenger and Camilla Fleetcroft. This week however Dr Penny Wilson, who will be familiar to many of you, took up position as a Deputy Director  and…
Ben Kemp
June 10, 2022
Membership NewsMembership News Archive

Delay to UKCA consultation response

The UK Government has entered into their pre-election period, which means that they are limited on what can and cannot be discussed in relation to policy. Because of this, MHRA have confirmed that there will be a delay to publishing the response to the MHRA UKCA consultation (which closed in November), until this period is over on 9 May. The…
Ben Kemp
April 14, 2022