Which expectations?
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.
Mrs. Willmott will be responsible for guiding the new rules through the European Parliament as well as negotiating with the Commission and national governments within the Council.
The ongoing revision of MDD Legislative Framework
The Revision of the Medical Devices Directives follows a number of scandals occurred in the past few years and 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.
The revision package consists of two proposals:
- Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
The new Regulations shall be adopted by the European Parliament and the Council in the course of the next few months and should gradually come into force between 2015 and 2019. They will replace the existing Directives on Medical Devices and In-Vitro Diagnostics.
What we should expect by the newly appointed Rapporteur?
The political background of Mrs. Wilmott, as well as her previous experience in the European Parliament make most likely that she will build up the upcoming revision on the following pillars:
- Strong focus on the protection of health and patients’ interests:
In this context, Glenis Wilmott announced that has announced that she will strive to bring devices oversight back to the Health Commissioner after it was decided only recently to bring it back to DG Enterprise. This approach contrasts with the recent decision by the new EU commission chief Jean-Claude Juncker to shift the European Commission Unit dealing with medical devices and cosmetics from the Directorate General for Health and Consumers’ protection (DG SANCO) to the Internal Market Directorate.
- Stricter requirements for the manufacturers:
In particular with regard to issues related to safety, vigilance and traceability of their devices.
- Increased importance of clinical evidence requirements:
Glenis Willmott has served as rapporteur for the recently revised Clinical Trials Regulation. Given her experience in this area, it is very likely that the upcoming European Legislation will be characterized by a stronger focus on the clinical evidence requirements that should support devices’classification.
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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