The MHRA updated their guidance documents to clarify their position reflecting an intended extension to acceptance of CE-marked medical devices on the Great Britain market beyond June 30th, 2023. Last week, one release followed another:
- On April 27th, the Implementation on the Future Regulations standard is updated with new transitional arrangements.
- On April 28th, the Regulating medical devices in the UK guidance is updated to describe the meaning of the intention to extend the acceptance of CE-marked devices on the Great Britain market.
On April 28th, guidance is published presenting practical scenarios for manufacturers and UK Responsible Persons to implement these updates: Guidance on registration of certain medical devices which are reusable Class I devices, up classified Class I devices, and/or reliant on expired/expiring CE certificates is the government’s intention to put in place legislation for this extension in Spring 2023, being subject to parliamentary approval. This will contribute to the ongoing safe supply of medical devices into the UK market. As published in the guidance documents, the timelines will not apply to Class I medical devices and general IVDs under the EU directives, where the conformity assessment under the relevant directive and under the EU MDR or EU IVDR does not involve a notified body.
What else can we expect?
- Legislation to strengthen post-market surveillance requirements. In light of the new future regulatory framework, this type of legislation is expected to be introduced later in 2023. These post-market surveillance requirements are expected to apply from mid-2024.
- Amendments that will put the future reliance on CE certificates in perspective of the Great Britain market. It is expected that the new regulatory framework fully applies from 1 July 2025. EU MDR and EU IVDR CE certificates that are renewed after the reformed regime is implemented are subject to UKCA certification. These devices can no longer rely on the CE mark to be placed on the Great Britain market.
Qserve continues to update you on the developments in the UK landscape through news flashes, blogs, white papers, and webinars. Next up, an interpretation of the timelines, reliance on CE certificates and what it means for different types of devices.