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1 March 2013
On 26 February, Health First Europe attended the Workshop on ‘Regulation on Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDMDs)’ at the European Parliament. The event was the first public discussion on the dossier and brought together stakeholders from the EU health community to provide their positions on the current proposal before discussions amongst policymakers begin in March. It was clear that while many welcomed a more robust legal framework for the regulation of medical devices, stakeholders differed in the approach to balancing the needs for safety against the needs for innovation in healthcare.
MEP Dagmar Roth-Behrendt (S&D, Germany), Rapporteur for the revision of the Medical Devices Directive (MDD) and chair of the meeting welcomed the participants of the first panel and invited them to give their perspective on the current system of approval of medical devices. Ms. Paola Testori-Coggi, Director General of the Directorate General for Health & Consumer (DG SANCO), began by illustrating the key points of the Commission’s proposal, particularly highlighting the need to “reconcile the highest possible level of safety with the need to maintain innovation and competitiveness.” To this end, the Commission’s intent was to make the legal framework for medical devices more robust and to improve the transparency and traceability of the system in Europe while maintaining the current de-centralised system to ensure rapid access for patients to medical technologies.
Providing the industry perspective, the CEO of Medtech Europe, Eucomed and EDMA, Mr. Serge Bernasconi, underlined the need for greater transparency and stronger traceability and reinforced the support of the industry for many of the new statutes contained within the proposal. However, Mr. Bernasconi also insisted that any additional scrutiny on high risk devices must be undertaken within an effective and predictable system. Mr. Bernasconi agreed that the current system needs improvement, but expressed concern about the considerable delays patients could face for new technologies under the current proposal for scrutiny.
Prof. Werner Siebert, Director at the Orthopedic Center in Kassel, re-affirmed that improvements to the current systems are necessary, but maintained that the processes must bring added-value and questioned whether scrutiny for high risk devices would indeed achieve that goal. This opinion was echoed by the President of the European Society of Cardiology (ESC), Mr. Panos Vardas, who offered another medical perspective on the discussion. Mr. Vardas reminded the audience that life expectancy has significantly improved in the last few decades because of innovative medical technologies. He expressed that “The current system for testing and approving devices in Europe was established more than 20 years ago, and the ESC feels it is now necessary to adapt the regulation to technological advances and changing patterns of medical practice.” The Commission’s proposal was welcomed by ESC, but Mr. Vardas explained that he sees room for improvement in some key areas particularly with regards to transparency and stressed that clinical evaluations of medical devices should only be undertaken by accredited bodies and that there should be greater involvement of doctors in the approval process as clinicians could offer independent expertise.
The Director of the European Consumers’ Organisation, Ms. Monique Goyens, indicated the inconsistency of the current system in terms of classification of devices and also asserted that there a variety of differences in processes for approval depending on the notified body involved. Ms. Goyens called for a multi-disciplinary group at EU level to determine classification of products (particularly borderline medical devices) and for an EU wide system for binding assessment on high risk devices (via the European Medicines Association). She stated that, “Innovation cannot be encouraged at the expense of safety.”
Following Ms. Goyens, Mr. George Jessen, Representative for Proctor and Gamble in the Association of the European Self-Medication Industry (AESGP) Committee on Medical Devices, raise the “principle of proportionality” issue expressing that the new proposal must “facilitate innovation in the medical technology industry in a responsible way.” Mr. Jessen argued that the current system is working, but needs to be improved and this could be achieved by strengthening notifed bodies.
The end of the session saw two representatives from the pharmaceutical industry presenting their opinions. Firstly, Mr. Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), expressed the importance of building trust between regulators through peer review, which is a basic principle in the field of pharmaceuticals. Mr. Bergström concluded his speech with a remark on reimbursement, an issue brought up by several speakers which often constitutes a real barrier for patients. He also urged policymakers to analyse what impact the proposed regulation would have on small and medium enterprises (SMEs) as such companies are unique to the medical device industry. Mr. Guido Rasi, Executive Director of the European Medicines Agency in London, followed Mr. Bergstrom’s remarks by recommending that a clear and harmonised definition of a device is proposed and indicated that while some have suggested the EMA play a role in medical technology regulation and oversight, the organisation has expertise only to contribute on borderline devices (such as companion diagnostics).
Overall, the discussions on medical devices provided a clear foundation of stakeholder views for the upcoming discussions on the proposed medical devices regulation. Clearly, the most important issue raised by all stakeholders was the need to ensure a high level of safety for patients. However, balancing the issue of safety against other concerns such as innovation, access and transparency, will be a clear challenge for policymakers as the discussions get underway.