Obelis European Authorized Representative Center (O.E.A.R.C.), 24 years in business and operating as one of the largest regulatory centers in Europe today, providing CE marking advisory services and European Authorized Representative services – officially welcomes the new proposals for new regulations on medical devices and in-vitro diagnostics medical devices as presented during the press conference, by the EU Commissioner for Health and Consumer Policy, John Dalli.
The revision proposal by the European Commission comprised of 2 proposals:
- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC covering active implantable medical devices and Directive 93/42/EEC covering medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
Among the many changes to be imposed on manufacturers, importers & distributors, notified bodies and competent authorities, Obelis welcomes such changes and specifically in reference to the role, functions and responsibilities of the authorized representative.
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