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

By July 1, 2022July 5th, 2022No Comments

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 found here.

Importantly, this sets out that there will be a transition period to allow manufacturers and economic operators to ensure compliance to the new system. This transition will be 5 years for IVDs, but there can be no significant changes made to the products in that time and the post-market requirements must be met. This is similar to the transitional arrangements which were introduced for the IVDR in January.

The planned regulatory route is reasonably aligned to the requirements in the IVDR, with some national divergences.

Ben Kemp