The U.K. has finalized and adopted legislation that will shape the post-Brexit future of medical device regulation.
Through the new law, the U.K. government has established powers to update regulations on medical devices and other health products. The legislation also supports the creation of databases, information flows and sanctions related to medical devices.
- Government politicians have framed the legislation as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh, which has been the subject of lawsuits, regulatory scrutiny and investigations around the world in recent years amid reports of adverse events.
The document underwent many changes between being introduced in February 2020 and finalized a year later. Notable amendments include the addition of a section mandating the creation of a patient safety commissioner and stipulations on when U.K. authorities can share information with foreign entities.
In the medical device section, the big change is the addition of 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 require information to be provided to the Health and Social Care Information Centre. The requirements apply "to any person who provides services, or exercises any powers or duties, relating to medical devices."
Lawmakers added provisions for the creation of the medical device database ahead of the release of an independent report into the handling of safety problems of products including pelvic mesh. The report recommended the creation of a "central patient-identifiable database ... by collecting key details of the implantation of all devices at the time of the operation." The government said the new chapter on information systems addresses the recommendation.
The rest of the finalized section on medical devices hews closely to the draft version introduced one year ago. After multiple debates in both houses of Parliament, the other changes are largely limited to the thinking that should guide the creation of new medical device regulations.
The final text states "safeguarding public health" must be the "overarching objective" of regulatory changes, a stipulation absent from the original document. In assessing whether a regulation meets that criteria, officials must consider the safety and availability of medical devices, as well as the likelihood of the U.K. being seen as a favorable place to perform certain work.
Lawmakers tweaked the favorability requirement during their debates, resulting in a final document that specifies authorities should consider the impact of new regulations on the likelihood of the U.K. being seen as a good place for medical device research, development and manufacturing.