Out-Law News 1 min. read
28 Oct 2022, 3:42 pm
New UK medical device regulations are to be brought into force by July 2024 – a year later than originally anticipated, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed.
The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimise the risk of supply disruptions for UK patients.
The delay means manufacturers whose medical devices have a ‘CE’ marking, which certifies their compliance with EU medical device regulations, will be able to continue placing their devices on the Great Britain market up until 30 June 2024, not 30 June 2023 as previously indicated by the UK government.
Last year the UK government and MHRA consulted on options to proposed changes to the regulatory framework for medical devices in the UK. In June this year, the response to the consultation was published in which the government confirmed (155-page / 1.25MB PDF) the new UK medical device regulatory framework will be built on five pillars – one of which is setting world leading standards, including by building the UKCA mark, the UK equivalent to the CE mark, as a global exemplar.
The new regime is also to be built on strengthened MHRA powers on patient safety, a renewed focus on innovation, addressing health inequalities and mitigating biases throughout the medical device product lifecycle, and proportionate regulation that supports businesses.
In its June publication, the government had said it hoped the new medical device regulations would come into force in 2023, though transitional arrangements will apply before the new rulebook has effect. The latest announcement means that the transitional arrangements are now scheduled to apply from 1 July 2024.
The government is intending to introduce legislation by spring 2023 that will bring into force the transitional arrangements, as well as the post-market surveillance requirements it announced in its June response paper, according to the MHRA.
Life sciences expert Louise Fullwood of Pinsent Masons said: “Combined with the Retained EU Laws Bill, it's a continuously moving platform for the medical devices industry. This further delay takes away the impetus for manufacturers to get UKCA-ready as the can continues to be kicked down the road with no certainty on what the eventual position will be.”
“A contributing factor to the announced delay is likely to be the relatively small number of UK approved bodies for carrying out conformity assessments – Dekra was appointed last month as just the third UK approved body. A further six organisations are currently going through the approval process and the MHRA is in discussions with several other potential candidates,” she said.
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