The NEW proposals for regulations for medical devices and in-vitro diagnostics medical devices, adopted by the European Commission last September (proposal 2012.541 & proposal 2012.542) were discussed at a public workshop held by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), on February 26th 2013.
These NEW proposals are intended to replace the current MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC and to be adopted and accepted by the EU Parliament & the Council of European Union is (under most cases) under an Ordinary Legislative Procedure (OLP).
Obelis’ notification officers, in charge of the pre-market notification of medical devices & in-vitro diagnostic medical devices as European Authorized Representative Center (OEARC) of such Non-EU manufacturers, participated to this workshop to provide a summary of the main topics presented:
- The improvement of the regulatory framework for medical devices in the EU
- The possibility of a pre-market notification
- The necessity of a scrutiny procedure for high risk devices (Class III) The classification of medical devices
- The definition of single-use devices and reprocessing
- The need of a more clarified definition of reprocessed medical devices was expressed along with the necessity of a structured reprocessing procedure
- The role of Notified Bodies
- A more rigid control of Notified Bodies was asked from the MEPs (Members of Parliament)
- Mechanisms in the new regulations were proposed to improve the quality and equality of Notified Bodies
- Unannounced audits from National Competent Authorities are already taking place.
- The EC proposal on IVDs
- The enhanced role of notified bodies
- Systematic clinical evidence
- A new classification system
- The setup of reference laboratories
- Special aspects of DNA testing
The ethical aspects of the medical data in-vitro diagnostic tests provide, were highlighted by the participants.
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