June 12, 2013 – The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments to the regulations last month. Not only were there more than 900 amendments; there were also several different amendments to the same clauses in some cases, according to life science lawyer Erik Vollebregt. In addition, Roth-Behrendt and IVD regulation Propel Rapporteur Peter Liese added amendments to each other’s proposals. It seems that the only thing everyone can agree on is that there needs to be more oversight over notified bodies.
Erik Vollebregt offers detailed insight into these developments on his blog medicaldeviceslegal.com. Despite Roth-Behrendt’s call for a PMA system for innovative medical devices in her report, the likelihood that such a system will be approved is small, said Vollebregt. Many ENVI members openly objected to such a system during the debate, even though some argued for it.
The fate of the final version of the new medical device regulations will start to clear on 10 July when ENVI votes on the amendments. The Parliament will vote on the new regulations in November.
The upcoming changes to the European medical device regulations will be discussed at a conference session at the MD&M East trade show later this month. MD&M East takes place 17 to 20 June 2013 in Philadelphia, PA, USA.
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