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New medical devices regulation – a liger in the EU legislative jungle

The recent vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI) has created a lot of concerns for the medical device industry in Europe. The main fear is that the proposed amendments will do little to improve patient safety and that we are now witnessing a grotesque political compromise in the making that will only add more layers of regulation and bureaucracy. The chief executive officer of Eucomed, Serge Bernasconi, stated in a press release 1,

“Let it be clear that this is a [premarket approval] PMA in disguise carried out on a case-by-case basis and will deal a blow to patient access and medical device innovation in Europe.“

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