The MHRA last week opened their consultation on Medical Devices Regulations for routes to market and in vitro diagnostic devices. This relates to the proposed pre-market Statutory Instrument which is planned to be laid before parliament next year.
The MHRA are seeking views as a number of changes have occurred since they previously consulted last year. Areas are:
– International reliance as a route to market, in addition to UKCA.
– Removal of UKCA marking, if unique device identification (UDI) is in place
– Amendment of classes for IVDs.
– Removal of sunset date for assimilated EU law from 2025. Assimilated EU law will continue until UK Medical Device Regulations are in place.
Regulatory Affairs Manager, Neil Plumridge, says “BIVDA are broadly supportive of these proposals, and welcome the MHRA’s revisions following earlier BIVDA feedback. In a global market, international reliance is a sensible step, as is removing unnecessary UKCA marking.”
BIVDA will collate member views and submit a response via our UKCA group. The UKCA Subgroup will be meeting virtually to discuss the consultation on 26th November, and tickets are available via Eventbrite.
The consultation, which closes on 5 January 2025, can be found here.
