Manufacturers can finally plan past the Brexit fog as the British government moves to accept the CE mark for medical devices indefinitely.
The policy shift follows an industry consultation where most participating stakeholders backed the permanent recognition of CE-marked products. Until the formal legislative process wraps up, the existing transitional rules remain active across the market.
Under the updated framework, the UK draws a distinct line between device approvals tied to older EU directives and those governed by newer regulations. Medical devices cleared under the European Union Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) can enter the British market until June 30, 2030, unless their certificates expire earlier.
Products authorized under older EU directives face a stricter cutoff of June 30, 2028. Meanwhile, in-vitro diagnostics approved under the former Directive 98/79/EG share the 2030 deadline. Specific product categories, such as custom-made items or self-declared goods, may encounter entirely different timelines.
Independent of upcoming legislative shifts, manufacturers have been required to register their medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) since January 2021.
Companies without a physical footprint in Great Britain must appoint a locally based responsible person. This designated representative manages product registration, maintains technical documentation and essential conformity records, and acts as the primary contact for the MHRA. Importers and distributors can also step into this role through a direct agreement with the manufacturer.
The domestic UKCA label remains a viable option for businesses operating in the region. That domestic designation currently relies on the exact same technical baseline found in older EU regulations.
