The European Union finally agreed late Wednesday Brussels time on a final text for the long awaited European Device regulations. these regulations will replace the current Medical Device (MDD), Active Implantable Device (AIMDD) and In Vitro Diagnostic Device (IVDD) Directives. But agreement is as only can be defined in the byzantine European political process. Agreement actually means that the text has been agreed between the Presidency and the represntatives of the European Parliament. It’s still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee. Hold the champagne a bit longer…
The text has not been publicly released yet but the EU press release emphasises that the text achieves what has been talked about for a long time:
- Stronger rules for placing on the market and tighter postmarket surveillance – including stronger oversight of Notified Bodies and unannounced inspections of manufacturers (of course this is already happening).
- Explicit provisions requiring manufacturer post market monitoring and follow up actions.
- Specifically defined liability of all “economic operators (not just manufacturers but distributors and some other parties) for device failures and responsibilities for actions in the vent of failure.
- Strengthened rules for high risk devices – including an additional premarket review by an expert panel.
- Inclusion of certain cosmetic devices within regulations for the first time.
- A central public database “for all relevant information” (not defined) intended to provide comprehensive information on available devices.
- Requirement for a unique identification number (i.e. implementation of UDI).
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