The DHSC has issued the below briefing note on the requirements of a responsible person in regards of regulating medical devices from 1st January 2021.
What are the eligibility requirements for a UK Responsible Person?
There are no additional requirements or qualifications needed, other than the need to be established in the UK. UK Responsible Persons need to be able to carry out the responsibilities stipulated in Regulating medical devices from 1 January 2021 guidance (which is based on draft The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020).
When does a UK Responsible Person need to be in place by?
For placing devices on the GB market we strongly recommend that UK Responsible Persons should be in place by 1 January 2021.
For placing devices on the GB market, UK Responsible Persons must be appointed by the dates devices need to be registered with the MHRA.
- Class I devices, custom-made devices and general IVDs must be registered from 1 January 2021. Class I devices, custom-made devices and general IVDs that do not currently need to be registered must be registered from 1 January 2022.
- Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021.
From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark has been affixed.
For placing devices on the NI market, you will need to appoint a UK Responsible Person within the UK by 1 January 2021 if you are an EU or EEA-based manufacturer.
However, EU, EEA and third country manufacturers won’t need a UK RP if they only intend to place a Class I device, custom-made device or general IVD on the Northern Ireland market, which has been registered with an EU Competent Authority.
Also, a third country manufacturer will not need a UK RP for any device class if their Authorised Representative is based in Northern Ireland.
When does an EU or NI based Authorised Representative need to be appointed by for GB manufacturers placing devices on the NI market?