The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance on registering medical devices and IVDs that was published at the end of 2020, adding a new section for IVDs undergoing performance evaluation. These IVDs are now included on the list of devices requiring registration with the MHRA.
The United Kingdom (UK) has left the European Union (EU) on February 1, 2020.From January 1, 2021, the transition period after Brexit ended, and the Medicines and Healthcare products Regulatory Agency (MHRA) took on the role as the UK’s standalone medicines and medical devices regulator.
UK Responsible Person (UKRP) – In order to place a medical device on the Great Britain Market, non-UK manufacturers will be required to designate a UK Responsible Person, physically based in the UK. The UK RP will act on the behalf of the manufacturer to carry out specific tasks. The responsibilities of the UK RP are similar to those of the EU Authorized Representative under the Directives. UK RP must ensure that the Declaration of Conformity and the technical documentation have been drawn up and the conformity assessment performed correctly. UK RP must terminate the contract and inform the MHRA and the relevant Notified Body. The UK RP will register the devices and provide a list of importers to the MHRA. Manufacturers should appoint a UK RP as soon as possible.
Placing a Device on the GB Market after 01 Jan 2021
Great Britain will recognize EU CE marking and EU NB issued CE certificates (both Directives and Regulations) Until 30 June 2023. In parallel from 01 Jan 2021 new route to market and product marking (UKCA) will be available for manufactures.
Requirements for placing IVD products undergoing performance evaluation
As per the Medical Devices Regulations 2002, UK Statutory Instruments 2002 No. 618 PART- IV Regulation 43 statement explains Devices for performance evaluation as follow:
No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or his authorised representative—
(a) has drawn up a statement containing the information required by Section 2 of Annex VIII of Directive 98/79/EC(IVDD) and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;
(b) ensures that—
(i) The device conforms with the documentation mentioned in the said section 2, and
(ii) The relevant requirements of the Directive are complied with as respects that device; and
(c) Undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.
The new section in the guidance consists of the following points:
- An IVD requiring a new UK performance evaluation study should be registered by the time the study commences, and no grace period will be applied.
- For existing on-going performance evaluations that began before December 31, 2020, the grace period provided in the guidance for the type of IVD (List A, List B, or general) remains applicable.
- A UK Responsible Person or Northern Ireland-based Authorized Representative must be appointed by non-UK manufacturers conducting a performance evaluation in the UK in order to register with the MHRA.
- For all performance evaluation studies a Declaration for performance Evaluation to UK MDR 2002 Regulation 43 statement (Annex VIII of Directive 98/79/EC) or Part A of Annex XIII of EU regulation 2017/746 is required.
Registration through MHRA DORS based online system:
Medical device undergoing performance evaluation will follow the same roadmap of registration as regular device follows (MHRA DORS based online system).
- You need to create an account on the MHRA DORS before you can start registering your devices. If you are already registered with the MHRA you need to confirm the accuracy of the registered information by the grace periods set out in the ‘When you must register’ section.
- During registration process, A Declaration for Performance Evaluation according to UK MDR 2002 Regulation 43 Statement (Annex VIII of Directive 98/79/EC (IVDD)) or Part A of Annex XIII of EU Regulation 2017/746 (IVDR) is required for all performance evaluation studies.
- Registration process section of directive/regulation device comply asked about “clinical investigation has been conducted” as optional part of comply section.
- A fee of 100 British pounds applies for each application. One application may cover up to 100 devices with a cumulative maximum of 20,000 products.
Note: MHRA refers to Global Medical Device Nomenclature (GMDN) and not to the European Medical Device Nomenclature (EMDN) codes needed for Eudamed.