Medical Device Regulatory Updates

by | Mar 28, 2024 | Blog, Medical Devices, MHRA

Those companies manufacturing and handling medical devices should be aware that there are changes to the UK regulatory environment coming. This will hopefully be the final piece in a series of significant changes to the way medical devices are regulated, that started way back in 2015/16. In the period since then UK operators have been in a state of pretty much constant change.

In January the MHRA published a road map for these changes, with indicative timelines. This will hopefully allow companies to plan with more certainty, though you will note that within the document there are dates that may be subject to change.

As a reminder the key areas that are likely to be included in the upcoming UK regulations are:-

  • Significant enhancements in the vigilance requirements for medical devices for all operators within the market
  • Clearly defined requirements/obligations on operators within the market, including distributors/wholesalers
  • Changes to the classification of some devices, with some moving up to categories that require Approved Body involvement

The addition of products not currently included within the definition of a medical device into the scope of the regulation such as some aesthetic products

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