The MHRA have announced a delay to the introduction of the future regulations in the UK. The updated guidance now states that the aim is for the new regulations to apply from 1 July 2025 – a further one year delay to what had already been announced.
The acceptance for CE marked medical devices on the GB market will also be extended from the current date of 30 June 2023. The intention is for the government to introduce legislation before this date to extend the date these devices will be accepted for up to 5 years for medical devices and IVDs CE marked under the EU MDR or EU IVDR respectively – bringing the date that these will be accepted to 30 June 2030. There will also be up to 3 years for medical devices CE marked under the MDD and up to 5 years for IVDs CE marked under the IVDD or until the expiry of the device certificate. Any devices that would be classified as Class I medical devices or Class A IVD’s must be CE marked under the EU MDR and EU IVDR respectively to be placed on the market during this transition period.
It is also confirmed that the additional post-market surveillance requirements will be introduced later in 2023 and are expected to apply from mid-2024.
Whilst this still needs to be approved by Parliament and there is still no clarification on the details of what the new future regulations will look like, this is welcome news to manufacturers.
For the full announcement see the link below: Implementation of the Future Regulations – GOV.UK (www.gov.uk)
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