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UK announcement on UKCA delay causes confusion for MedTech

  • Posted by: inetika
  • Category: GLOBAL NEWS

The announcement by the UK Government Department for Business and Trade (DBT) on 1 August 2023, that a broad acceptance of CE marks instead of the UKCA mark for the forseeable future, briefly caused confusion among the medical device community, considering that only weeks before had the transition deadlines for legacy medical devices been extended by several years. That is until it was noticed that ‘Medical Devices’ were not included on the list of the affected 18 Regulations.

This was clarified by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in a follow-up communication later in the day, titled ‘CE marking recognition for medical devices and in vitro diagnostics’. In this, it is clarified that the earlier communication concerned only those regulations for which the DBT exercised control, and that medical devices were under the control of the Department of Health (DOH). The MHRA pointed instead to its webpage on which is described the ‘Implementation of medical devices future regime’, which was last updated only four days before the DBT announcement.

The MHRA also provided a timeline infographic on the gov.uk website, providing the newly extended transition timescales for medical devices and IVDs.

So the conclusion is that medical devices are benefitting from an extended legacy device timeline, while products under the other 18 regulations no longer have to worry about a UKCA marking deadline if they have a CE mark.