Brussels, 14 June 2012 – The European medical technology industry association Eucomed takes note of the final vote of the European Parliament (EP) on the PIP resolution. The Parliament fully endorsed the wording that was originally proposed by the Environment and Health Committee (ENVI) on April 26.
The adopted resolution calls on the Commission for measures to increase patient safety and improve the current regulatory system, in line with Eucomed’s proposal, including:
- the strengthening of the designation and control of Notified Bodies in the EU, also with respect to their skills and resources;
- better vigilance reporting and coordination of member states on incident assessments;
- increased and unexpected controls of manufacturers by notified bodies based on experience from the post-market phase;
- establishing tools to ensure the traceability of devices, in particular implants;
- establishing registers for implants and having the registers interconnected.
However, the EP also called for - although with a thin majority - a Pre-Market Authorisation (PMA) system for medical devices, as is already the case for pharmaceuticals. Adopting a pharma-like system for devices would not address the different nature and innovation cycles of medical technologies. Moreover, it would not lead to an effective increase in patient safety, but may cause years of delay in the availability of medical technology solutions to European citizens and a loss of European innovation competitiveness compared with other regions. Europe already today has a pre-market approval mechanism in place for high-risk devices which has proven to deliver a high level of safety and provides European citizens with access to innovation 2-3 years before their US counterparts.
Eucomed recognises the need for improving the effectiveness of the current European regulatory framework for medical devices and has called for a legal framework that provides a consistent, EU-wide regulatory approach through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU Member States, as well as efficient vigilance and market surveillance systems. Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence.
In his address to the Parliament yesterday Commissioner’s Dalli announced that the proposal by the European Commission will include a pre-market scrutiny mechanism for the quality of Notified Body assessments for high-risk devices. Industry would be supportive of such a mechanisms provided it proves to enhance patient safety and would not slow down the approval process of medical devices. The latter point is critical in order to ensure timely patient access to innovative, efficient and cost-effective devices and for keeping innovation in Europe. Eucomed looks forward to the Commission’s proposal which should provide legal certainty on the aforementioned points of patient safety and approval times of medical devices.
Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. For more information visit www.eucomed.org
Ingmar de Gooijer
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M: +32 (0)492 97 14 70