Regulation (EU) 2023/607, which gives manufacturers more time for the certification of certain medical devices under Regulation (EU) 2017/745 on medical devices (MDR) will be reflected in updated guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), so that there will be no scarcity of medical devices on the market.
Like in the EU, in the UK extension of the transition period for class III and certain class IIb implantable devices (like pacemakers) will lead to a new legacy products deadline of 31 December 2027. The transition period for other class IIb devices, class IIa, class Im, Is and certain class I devices (e.g. reusable surgical instruments) will be extended to 31 December 2028.
The move will mean that European manufacturers can continue to provide the UK market with medical products without requiring an exceptional use authorisation. No exact timings were divulged for the upcoming statutory instruments yet.
Source: Medtech Insight (an Informa product)