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Actions manufacturers can build into their regulatory planning as UK nears new regime
As the medical device industry prepares to enforce new rules post-Brexit, Maetrics, a global life sciences consulting firm, unveiled a 10-task guide that consolidates the requirements of the new UK government and suggests areas that manufacturers should focus on. This includes information relevant to the UK Conformity Assessment certification (UKCA mark), a symbol that the UK government says covers most goods that previously required the CE (Conformité Européenne) marking, which could be found on many products in the European Economic Area (EEA).
Manufacturers, who are working diligently to stay within the rules laid out by both the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), need to also be mindful of the fact that businesses that have products on the UK market will need to follow the rules presented under this new leadership. It’s worth noting that that these companies have additional time—the EU MDR date has been pushed to May 2021.
For efficiency purposes, one of the initial priorities for impacted companies will be to track the commonalities between these EU and UK regulations. They should monitor developments as the situation progresses.