Brexit’s MHRA guideline for medical devices
The British competent Authority MHRA has published a guideline on their website on the Brexit, that is constantly updated: “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal”.
In particular, a section was published during the latest update on 4th January 2019 regarding the registration of medical devices marketed in the United Kingdom.
As of 29th March 2019, ale medical devices, active implantable medical devices, IVDs and custom-made medical devices needs to be registered at the MHRA before being marketed in the United Kingdom.
As this is an extension of the registration requirement in force, there will be a grace period to comply with the new registration process, in particular:
- 4 months → class III medical devices, class IIb implantable medicinal devices, active implantable devices, IVDs included in the Annex II list A;
- 8 months → class IIb non implantable medicinal devices, class IIa medical devices, IVDs included in the Annex II list B, self-diagnostic IVDs;
- 12 months → class I medical devices, other IVDs
In case a manufacturer is not located in the UK, the registration of products at MHRA shall be made through a ‘UK Responsible Person’ located in the UK.
The UK Responsible Person will be responsible for the products marketed in the UK.
Written By: Felisiano Cipressi
