On December 1st 2014 The European Council took note of the progress report of the Italian presidency on the two proposals for new regulations on medical devices and in vitro diagnostic medical devices.
The report noted that considerable progress has been achieved on these files under the Italian presidency. However, further discussions are needed for the Council to agree its position.
Outstanding issues:
- Aesthetics Devices: the report noted that 15 delegations favoured inclusion of aesthetic devices under the scope of the Medical device Regulation
- Ingested Products: inclusion of certain substances intended to be ingested, inhaled or administered rectally or vaginally (“Ingested products”) into the scope of the Regulation. It further provides that all these devices be classified as high risk devices (“Class III”)
- The Unique Device Identification System (UDI): the Commission proposal contains a requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows for traceability.
- Stricter rules for Notified Bodies. Mechanisms for surveillance and appointment of the Notified Bodies responsible for the conformity assessment.
- Clinical Investigation: the discussion is going in the direction of further aligning the provisions on ethical and methodological principles to those for clinical trials of medicinal products.
Background
The Revision of the Medical Devices Directives is aimed at guaranteeing a higher level of protection for patients and users, while ensuring the free circulation and easier trade of medical devices within the European Union.
On September the 17th 2014, the European Parliament appointed Glenis Wilmott – UK member of the Labor Party – as new rapporteur for the ongoing revision of the Medical Devices Legislation.
Professional advice and in-depth expertise will constitute fundamental factors for the manufacturer to be constantly updated and to follow-up on the upcoming regulatory changes. The consultancy of Professional and knowledgeable European Authorized Representative will constitute a remarkable competitive advantage for non-European manufacturers.
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