New medical devices laws have been published in the EU's Official Journal.
The two new regulations, on medical devices, and in vitro diagnostic medical devices, were finalised earlier this spring following negotiations between the European Parliament and Council of Ministers. The regulations will officially become law on 26 May. However, the regulations will not actually apply until 26 May 2020 and 26 May 2022 respectively.
Intellectual property law and life science expert Allison Sadick of Pinsent Masons, the law firm behind Out-Law.com, previously said: "The introduction of these new rules not only means that there is tighter regulation of medical devices but recognises that medical devices have made significant technical advances and valuable contributions to the field of medicine such that it warrants attention and a higher level of regulation akin to medicines."
"In light of the new rules and revision to the medical devices framework, this would be an opportune time to ensure there is parity between the regulation and corresponding intellectual property protection of medicines and high risk medical devices so that medical device manufacturers are seemingly not at a disadvantage for bringing innovative devices to market versus their pharmaceutical counterparts," she said.
"This is particularly the case where patent term extensions in the form of supplementary protection certificates are only being granted in respect of medicines and not for high risk, more invasive and more complex medical devices despite these having to demonstrate similar regulatory/conformity assessments," said Sadick.
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