Brexit - changes for the medical market

The beginning of a new year seems to be a good occasion to remind you that, apart from upcoming MDR, we will have to face a series of changes caused by Brexit.

These are the most important ones taking effect from 1 January 2021:

• certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
• the EU no longer recognises UK Notified Bodies
• UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland) – and have become UK Approved Bodies
• all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA (Medicines and Healthcare products Regulatory Agency). There is a grace period for registering which depends on the class of the medical device. For further information see:

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible

• if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain.
• the CE marking will be recognized in Great Britain until 30 June 2023. From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA (UK Conformity Assessed ) marking requirements.
• if you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA mark until 1 July 2023 for placement on the UK market.
• devices can have both marks (CE and UKCA) present on the labelling before 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023. However, it is necessary to place the name and address of the UK Responsible Person (where applicable) on product label where the UKCA mark has been affixed (including when devices have been dual marked).

Please remember that from 1 January 2021 placing a medical device on UK market and UKCA marking are based on the requirements of the relevant Annexes to the Directives listed below, which are given effect in UK law through the UK MDR 2002 (as amended):

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).

The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. The provisions contained within those regulations will not be transposed into law in Great Britain and will not be implemented in Great Britain. However, products CE marked under the MDR/IVDR will accepted in the UK until 01 July 2023.  Thereafter, the British legislator intends changes of regulatory regime for medical devices placed on the market in the UK that would prioritise patient safety and take into consideration international standards and global harmonization.

We would like to strongly advise you to review your product portfolio and consider whether your business is likely to be affected by those changes. Please, do not hesitate to contact PCBC with regard to products under Notified Body certification.