February 23, 2021
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 by a UK-based manufacturer or Authorized Representative in Northern Ireland. No grace period is to be offered for registration of IVDs undergoing performance evaluation.
Contents of guidance for registering IVDs undergoing performance evaluation
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 ongoing 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.
- 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.