Medical devices can be placed on the market through 2030 even without a UKCA mark
Brexit has even more impositions in store for the medical device industry. As regulations which only apply directly in EU member states, the MDR and IVDR do not apply for the placement on the market and distribution of IVDs in Great Britain (England, Scotland and Wales). They do apply in Northern Ireland, in accordance with the Northern Ireland Protocol.
exception for Class I medical devices
The above deadlines do not apply for Class I medical devices and general IVDs subject to Directives for which conformity assessment does not require the involvement of a notified body. They also do not apply for custom-made devices conforming to the MDD or IVDD. In cases involving these devices, an assessment must be made on a case-by-case basis.
deadline extension does not apply for other “special” regulatory requirements
Based on current information, the proposed deadline extension for use of CE marking will have no impact on the other special requirements for placement of medical devices on the British market, particularly the need to appoint a UK Responsible Person, as well as the registration, post-market surveillance and vigilance requirements.
Medical device manufacturers are therefore compelled to subject their products to an additional conformity assessment procedure and to comply with new labelling guidelines and regulatory requirements in order to sell their products on the British market – unless they want to discontinue operations in the UK altogether. It was originally expected that acceptance of CE markings for the placement of medical devices on the British market would end on 30 June 2023.
This deadline has been discussed several times since then and is now apparently “off the table.” In order to counteract the foreseeable shortages in the supply of medical devices, the British government is planning to extend the approval of CE-marked medical devices on the British market beyond 30 June 2023. The relevant legislation will instead be implemented as of 1 July 2025.
Specifically, the following deadlines are mentioned:
- Medical devices which conform to the EU Medical Device Directive (MDD) or the EU Active Implantable Medical Devices Directive (AIMDD), and which have a valid Declaration of Conformity, CE marking and a valid certificate from a notified body, may be placed on the British market through 30 June 2028 or until the certificate expires, whichever comes first.
- In-vitro diagnostics conforming to the EU In-Vitro Diagnostics Directive (IVDD), and which have a valid certificate from a notified body, may be placed on the British market through 30 June 2030 or until the certificate expires, whichever comes first.
- Medical devices which conform to the MDR, including custom-made devices , an IVDs which conform to the IVDR, may be placed on the British market through 30 June 2030.
Securing access to the British market continues to be a challenge for medical device manufacturers. While the new deadlines make this task somewhat easier, the numerous and inconsistent official communications from the UK government and the MHRA mean that it will have to be determined on a case-by-case basis which regulations apply in each specific case. Please let us know if we can help you in this regard.back