BREXIT: Medical Device/Combination Products – Key changes

PharmaLexperts – taking a pragmatic approach to Brexit….

On 01 September 2020, MHRA laid out the future requirements for placing devices on the UK market after the end of the Brexit transition period at the end of 2020. Our team, which includes SMEs from the UK and the EU, is here to work with you to map out the impact for your operations and offer cohesive, practical solutions to assist you with a smooth transition.

Key Changes for Medical Device/Combination Products:

• UK Conformity Assessed (UKCA) Mark: CE marking will continue to be recognised until the end of June 2023, when a new regulatory framework will be introduced for the UK, resulting in the UK Conformity Assessed (UKCA) mark. However, as the MDR and IVDR enter into force after the end of the transition period, these will not automatically apply in the UK. It is important to note that any UK Notified Bodies designated under the current directives (MDD/AIMDD/IVDD) will not have to undergo a new designation process.
• Device Registration: Devices placed on the UK market will need to first be registered with the MHRA. Non-UK manufacturers must also assign a UK Responsible Person (UKRP). There is a grace period for these notifications based upon classification, but the highest risk products need to be registered by April 2021 (NB. the grace period only applies to products that would not need to be registered with the MHRA under the current requirements).
• UK Responsible Person (UKRP) Legal Responsibilities: The UK Responsible Person’s role is to ensure the technical documentation and declaration of conformity have been drawn up and keep copies on file. They are expected to respond to any requests from the MHRA and forward such requests to the manufacturer to facilitate provision of samples of the medical device. Additionally, the UKRP must immediately inform the manufacturer of any complaints or reports received about the devices for which they are designated. Finally, the UKRP must terminate the legal relationship with the manufacturer if they act contrary to its obligations under the regulations and inform the MHRA and any involved notifying body accordingly.

We will follow up with additional details/clarifications as more information becomes available, and in the meantime, please feel free to contact us at brexitsupport@pharmalex.com.