Published on:
28. January 2021
Brexit and its implications for CE marking of medical devices and in vitro diagnostics
A very eventful year lies behind us. The Corona pandemic had a massive impact on all areas of life and is still not over yet. Beyond this it has also affected the medical device sector in many ways.
Who would have expected in February 2020 that the long announced date of application of the Medical Device Regulation (MDR) would be postponed by one year? Who would have thought 8 months ago that audits could also be conducted as remote audits? Beyond this also Brexit continues to present us with large challenges.
Distribution of devices in the UK market will be more difficult. The new EU Medical Device Regulation (Regulation 2017/745, MDR) as well as the In Vitro Diagnostics Regulation (Regulation 2017/746, IVDR) will not be adopted to UK regulatoins. Due to Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA), as the responsible authoriy in the UK, has published newly adopted rules for the UK market that will apply for placing of medical devices on the UK market from 2021 on. The guidance on regulating medical devices in the UK provides details on the changes starting January 1, 2021, and the transition periods that will apply in the future.
The most important information at a glance:
UKCA marking: as of January 1, 2021, the new UKCA mark was introduced to replace the CE marking in the medium term. Within the risk class-specific transition periods (at the latest by June 30, 2023), the marking can already be used voluntarily. From July 1, 2023, the UKCA label will be mandatory for all products in the UK market (with the exception of Northern Ireland). The current requirements for UKCA labeling are based on the requirements of the European Directives (MDD and IVDD). Nevertheless manufacturers should expect a higher administrative burden.
- Conformity assessments by Notified Bodies based in the EU, however, will continue to be valid during the transition periods for market access in the UK.
- Registration of all medical devices: Staggered by risk class, registration of all medical devices with the MHRA will be mandatory from January 1, 2021. Registration of all devices from January 1, 2021 is therefore recommended. You will find all relevant deadlines here.
- Designation of a Responsible Person: manufacturers without a subsidiary in the UK are required to designate a Responsible Person. However, it is possible for importers or distributors to take on this role in consultation with the manufacturer.
- Special status for Northern Ireland: In Northern Ireland, the EU medical device regulations continue to apply with all known transition periods. Thus, both the Directives and MDR and IVDR will be applied in Northern Ireland, although these regulations will no longer be valid in Great Britain. For the Northern Ireland market, the use of the CE marking will therefore also continue.
The new regulations that have come into force for the UK market are currently posing new challenges for all parties involved. mdc is intensively dealing with the requirements necessary in Europe and is examining the necessary steps and possibilities in order to also be able to offer such certification. We will inform all mdc customers in due time.
Stay healthy!
Your mdc team