14 November 2012 – Health First Europe attended the Seminar “Medical Devices: is the new legislation sufficient to protect patients?” organized by the ALDE Group at the European Parliament. The Seminar brought together representatives from the EU institutions to give their perspectives on the proposal for a revised Medical Devices Directive published by the European Commission in September.
MEP Corinne Lepage opened the seminar by welcoming the opportunity to discuss the crucial issue of revising the European legislation on medical devices. Afterwards she gave the floor to Ms. Sabine Lecrenier, from the Directorate General for Health and Consumers of the European Commission, and MEP Peter Liese, Rapporteur for the proposal for a Regulation on in-vitro diagnostic medical devices, who informed the participants on the perspective of the European institutions with regards to the proposed legislation.
Ms. Lecrenier pointed out that the current legal framework consists of Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. Ms. Lecrenier suggested that the new proposal is meant to adapt to scientific progress and to address the weaknesses of the existing system as well as to take over international developments in the field. Ms. Lecrenier explained the main changes that the proposed legislation would bring about. First of all, the scope of the regulation will be extended to cover products utilizing non-viable human tissues and invasive devices without medical purpose (e.g. aesthetic). Secondly, she explained that the Commission proposal aims at introducing stricter minimum legislative requirements for medical devices as well as increasing the power of notified bodies responsible for assessing the safety of devices for market approval . Lastly, the new legislation provides for a centralized system for reporting incidents and seeks to further improve transparency.
MEP Peter Liese, Rapporteur for the Regulation on in-vitro medical devices, told the audience that a revision of the current regulatory framework is urgently needed. Speaking on behalf of the EPP Group, MEP Liese declared that pre-market approvals by Member States are not the best way to address the issue. Such measures, he pointed out, would not have prevented the breast implant scandal from happening and hinder rapid access for patients to innovative medical technologies.
MEP Mairead McGuinness intervened in her role as appointed Shadow Rapporteur on the Regulation proposal on medical devices. She drew attention to the key role of medical professionals who are the link between the patients and the industry. She felt that medical professionals should be better informed about products and safety standards. She expressed, “Policymakers shall not forget that the life of many patients significantly improved thanks to innovative medical devices and therefore innovation shall be allowed to flourish.”
Ms. Lecrenier welcomed the point raised by MEP McGuinness and ensured her that the Commission is trying to keep a balance between the exigency to ensure safety and the need to let innovation thrive in Europe.
The second panel was moderated by MEP Rebecca Taylor, who invited different academics and stakeholders to share their point of view with the audience. Dr. Alan Fraser from the Wales Heart Research Institute was representing the European Society of Cardiology (ESC). He gave a clinical perspective on the recast of the directive referring to the recommendations on the clinical evaluation of cardiovascular devices elaborated by ESC. Dr. Fraser stressed that greater transparency and expert professional advice are vital to ensure safety forpatients.
On his part, Mr. Serge Bernasconi, CEO of MedTech Europe, stressed that the amended legislation should not make it harder for patients to access medical devices. According to the industry, the revision should aim at ensuring patient safety by preventing incidents, but it should also guarantee that essential and necessary technology is available to patients without hampering innovation. This, said Mr. Bernasconi, can be achieved by strengthening post-market surveillance and by enhancing the traceability of products.
Ms. Ilaria Passarani from the European Consumers’ Organisation (BEUC) considers the revision of the regulatory framework a unique opportunity to improve consumers’ protection. After sharing with the audience a video recorded by a Spanish woman who received toxic breast implants, she stressed the need of providing adequate information to patients and particularly welcomed the proposed new legislation insofar as it provides for greater traceability and closer cooperation among Member States.
Mr. Hans-Heiner Junker, Representative of the European Association for Medical Devices of Notified Bodies, welcomed the proposal of the Commission in its entirety and was very pleased to see all stakeholders involved in the discussion. The Notified Bodies are particularly satisfied with the new legislation providing a legal basis for them to test products that are already on the market. MEP McGuinness then raised the point of the striking differences among Notified Bodies, considering that around 20% of them are carrying out most of the work for all European medical technologies and that somee lack the relevant experience.
Overall, the seminar was a unique occasion to stimulate the debate among the stakeholders and the institutions on the new legislation which will no doubt impact patients. MEP Taylor concluded the conference by saying that patient safety is the number one priority for everyone and called for a future-proof legislation.