There are a range of changes for companies wishing to sell their medical device/IVD products in the UK post Brexit. To complicate matters, Northern Ireland is now regarded as part of the EU and here separate rules apply.
St Gilesmedical is offering a service to medical device manufactures based outside of the UK who wish to continue selling in the UK, or plan to introduce new devices here. In the first instance, they need a local ‘Responsible Person’ (RP) to register product details with the Medicines and Health products Regulatory Agency (MHRA) and manage correspondence. There is a timescale for registration depending on the degree of product risk e.g. by May 2021 in the case of a Class 3 device such as a heart valve and by December 2021 for an external limb splint. Where products involves chemicals or substances e.g. surgical lasers, manufactures may need to transfer their registration to UK-REACH.
For now, the CE Mark is accepted in the UK but needs to be replaced by the UKCA Mark before June 2023. For more risky products (Class 1s, 2a, 2b and 3) this may require review by a UK Notifiable Body (yet to be appointed). For UK manufactures wishing to trade in the EU, they will need both a UK-awarded UKCA and a EU-awarded CE Mark. This means extra cost and paperwork for all concerned.
The regulations are currently awaiting UK governmental approval and may change.
St Gilesmedical Ltd is now registered with the MHRA as a RP and can advise non-UK manufactures and manage all the necessary paperwork. EU companies may like the fact that we have a Berlin office, can work in both English and German and bring added value though our medical writing, research, film and education activities.