UK: MHRA provides registration requirements for IVDs undergoing performance evaluation

• IVDs subject to new performance evaluation studies in the UK must be registered by the time the study commences (no grace period).

• For existing ongoing performance evaluations (commenced before 31 December 2020), the grace period as per IVD classification applies.

• Non-UK manufacturers conducting performance evaluation in the UK will require a UK Responsible Person or Northern Ireland-based Authorised Representative.

• All performance evaluation studies requires 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.

Source: Register medical devices to place on the market - GOV.UK (www.gov.uk) Contact us at info@arqon.com for more info