Clear some space on your regulatory bookshelf! You’re going to need room for your copy of the UK’s newly-adopted post-Brexit medical device legislation.
The new law grants the U.K. government the power to establish regulations on medical devices and other health products.
This legislation furthers the effort to fix systemic failures that delayed regulatory responses to safety problems seen with products such as pelvic mesh, which has been plagued with reports of adverse events in recent years.
The legislation also supports the creation of databases, information flows and sanctions related to medical devices.
The medical device section includes a new chapter on the establishment of information systems relating to post-market safety and performance, the safety of individuals and the improvement of “safety and performance through advances in technology.”
Another part of the new chapter states officials may that “any person who provides services, or exercises any powers or duties, relating to medical devices” provide information to the Health and Social Care Information Centre.
This post-Brexit medical device legislation won’t be quite as weighty a tome as the MDR, but will still contain enough headache-inducing detail and small print to have you reaching for the ibuprofen.
Link to the original article: https://www.medtechdive.com/news/uk-adopts-medical-device-legislation-setting-stage-for-new-databases-and-s/
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