Regarding medical devices of EU origin that want to be sold in the British market (GB), the dates have been updated on the products that will continue to be marketed with EU conformity certificates that are valid and had been issued before Brexit. A Responsible Person must also be appointed in the UK for those EU companies, not established in the UK, that wish to market new or old products with CE marking that are no longer valid, and therefore must apply for the UKCA British marking.
A) The general rule will be that new certificates of conformity issued by the EU will not be valid in the UK and will require the "UK equivalent certificate of conformity", the UKCA marking, in order to be marketed in the UK from January 1, 2021.
- Manufacturers wishing to place medical devices on the UK market have a new route and marking (the UKCA marking).
- All medical devices, including in vitro diagnostic devices (IVDs), custom-made devices and systems or equipment for procedures, have to be registered with the MHRA before being placed on the market. New registrations or changes to existing registrations cost a standard fee of £100 per application.
- Manufacturers based outside the UK who want to place a device on the UK market must appoint a UK Responsible Person, who will act on their behalf to carry out tasks such as registration.
B) Exemptions for those products that had a CE marking/certificate, prior to Brexit, and it has not yet expired, it is in force.
A transitional period has been established for placing CE marked medical devices on the market according to the following deadlines:
- Medical devices that comply with the Medical Devices Directive (EU MDD - 93/42/EEC) or the Active Implantable Medical Devices Directive (EU AIMDDD - 90/385/EEC) with a valid declaration of conformity and CE marking can be placed on the UK market until their certificate expires or until June 30, 2028, whichever is earlier.
- In vitro diagnostic medical devices that comply with the In Vitro Diagnostic Medical Devices Directive (EU IVDDD - 98/79/EC) may be placed on the UK market until their certificate expires or until June 30, 2030, whichever is earlier, and
- Medical devices, including custom-made or personalized devices, that comply with the Medical Devices Regulation (EU MDR - EU Regulation 2017/745) and in vitro diagnostic medical devices that comply with the In Vitro Diagnostic Medical Devices Regulation (EU IVDR - EU Regulation 2107/746) can be placed on the UK market until June 30, 2030.
If medical devices are placed on the UK market under these transitional measures, manufacturers will not be able to do so on the basis of expired certificates (unless these have been deemed valid by the EU).
If third party conformity assessment is required for UKCA marking, a UK Approved Bodies is required. The EU does not recognize UK Notified Bodies and UK Notified Bodies cannot issue CE certificates.
C) Responsible person (EU manufacturer's representative in UK)
Manufacturers based outside the UK who wish to place a device on the UK market must appoint a UK Responsible Person. This person must provide written proof that they have the manufacturer's authorization to act as such. Importers and distributors do not have to appoint a Responsible Person.
Authorised Representatives based in Great Britain who did not upgrade their role to Responsible Person on the MHRA Register were suspended on January 1, 2022. The Responsible Person acts on behalf of the overseas manufacturer to carry out certain tasks related to their obligations, such as registration with the MHRA before devices can be placed on the UK market.
Their responsibilities are defined in the Medical Device Regulations 2002, and in addition to registration, they have among other duties:
- Ensure that the declaration of conformity and technical documentation have been prepared and, where applicable, that the appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments or supplements for inspection by the MHRA.
- At the request of the MHRA, provide the necessary information and documentation demonstrating the conformity of a device.
- If they have samples of devices or access to devices, comply with the MHRA's request to provide the sample or access to the device.
- If they do not have samples or access to the device, they shall communicate to the manufacturer the MHRA's request to provide it, and shall communicate to the MHRA whether the manufacturer will comply with their request.
- Cooperate with MHRA on preventive or corrective measures to eliminate and, if not possible, mitigate risks from a device.
- Immediately inform the manufacturer of complaints or reports from healthcare professionals, patients and users about suspected incidents involving a device for which they are designated.
- If the manufacturer acts contrary to their obligations under the regulations: terminate the contractual relationship with the manufacturer and inform MHRA and if applicable the authorized body of the termination.
Nothing prevents an importer or distributor from also acting as a Responsible Person in the UK. In cases where the UK importer is not the Responsible Person in the UK, the importer must inform the manufacturer or the Responsible Person of its intention to import the device. The Responsible Person must provide MHRA with the details of the device importers.
The name and address of the Responsible Person in the UK must be included on the product labeling, either on the outer packaging or on the instructions for use. The details of the UK Responsible Person do not have to be included on the labeling of CE marked devices, unless it bears both CE and UKCA markings.
The name and address of the importer or distributor need not appear on the label unless they are acting as a Responsible Person in the UK for UKCA marking purposes.
For more information, access the Medical Devices Guide of the Spanish Economic and Commercial Office in London.