Author: Dr Áine Fox, executive with the Irish Medical Devices Association

The medical technology industry in Europe enjoys a leading role in innovation worldwide and our current regulatory framework forms a significant basis for other national frameworks around the globe. The sustainability of Europe’s healthcare systems in the future is dependent upon innovation and currently, European patients have the advantage of timely access to safe and innovative technology thanks to an effective decentralised approval system. In September 2012, the European Commission adopted proposals for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices. The Revision proposals are currently undergoing legislative scrutiny at European Parliament and Council. The Commission’s intention in publishing the proposals is to unify, simplify and modernise the existing legislation, which has been in place for nearly twenty years. The Commission aims to create a system that will introduce more transparency, more co-ordination among authorities and tighter controls over notified bodies and high-risk devices. The European medical device and diagnostics industry welcomes the majority of the Commission’s proposals, as they improve patient safety, do not delay patient access to life-saving medical devices and do not hinder innovation. However, industry  expresses strong concern over the Commission’s proposed Article 44 ’Scrutiny procedure’, which has the potential to negatively impact upon Europe’s innovative medical technology ecosystem, which is dominated by small- and medium-sized enterprises. Other critical elements of the Revision proposals where industry suggests improvements include the notified body system, vigilance co-ordination, transparency, stakeholder involvement, traceability, reprocessing and clinical data.

DRAFT REPORT ON PROPOSAL

April saw the publication of draft reports of the Committee on the Environment, Public Health and Food Safety (ENVI) rapporteur MEP Dagmar Roth-Behrendt on the proposal for a Regulation on medical devices and MEP Dr Peter Liese’s proposal for a Regulation on in vitro diagnostic medical devices. Significantly, in her report, MEP Roth-Behrendt called for the introduction of a pharma-style pre-market authorisation approach to be centralised in the European Medicines Agency for certain high-risk innovative medical devices. Whilst medical device manufacturers acknowledge that the current decentralised approval system can be improved, it is feared that fundamental transformation of the approval system to a centralised approval system, as seen with US Food and Drug Administration, will not improve safety and will significantly delay life-saving medical technologies reaching patients. MEPs have analysed both reports and tabled more than 900 amendments to the Commission’s initial proposals. The Irish Medical Devices Association (IMDA), a business sector in the Irish Business and Employers Confederation (IBEC), represents more than 150 Irish medical technology companies. The Association has been actively interacting with key stakeholders on behalf of the Irish medtech industry during the legislative process. Since the proposals were unveiled last September, representatives from the IMDA have been meeting with key Irish MEPs and the Permanent Representation of Ireland to the European Union, in order to clarify the Irish medtech industry position on the Revision proposals and to address any questions raised by MEPs on the regulation of the sector and on the implications of the Revision proposals on same.

QUALITY AND REGULATION ISSUES

IMDA member companies are being kept up to date with latest information as it emerges from Brussels and the Revision proposals have been a key element of the IMDA Quality & Regulatory Forum, which is a twice-yearly meeting focusing on sector quality and regulatory issues, since the initiative to revise the regulatory framework for medical devices was first announced. The European Parliamentary negotiation process will culminate in an ENVI committee vote on the proposals next month, with a European Parliament plenary vote scheduled for September 2013. The adopted report of the plenary will represent the official position of the European Parliament for  negotiations with Council. Both the Parliament and the Council must agree on a final compromise and whilst Parliament wishes to reach final agreement before the Parliamentary elections in May 2014, it is not evident at this time whether Council analysis of the proposal texts is moving at a fast enough pace to achieve this goal. It is clear, however, that agreement on the Revision proposals would be broadly welcomed by stakeholders before European Parliamentary elections next year. The intervening time between July and September represents a critical phase for the medtech sector and it is a final chance for industry to ensure that key stakeholders, Parliamentarians and national governments of member states, understand the importance of retaining the current decentralised notified body system and the potential negative impact of the Commission’s proposed ‘scrutiny procedure’ upon innovation within the sector. Moreover, Europe’s medical technology industry needs to begin to plan for the changes which the new Regulations will almost certainly bring, as they come into force in EU member states.

Áine Fox is an executive with IMDA, a business sector within IBEC. Before joining IBEC, she worked in both R&D and technology transfer in Abbott Diagnostics over several years. Prior to joining industry, Fox carried out postdoctoral research at the University of Lausanne, Switzerland and at the National Centre for Scientific Research (CNRS) in Marseille, France. She holds a BA (Mod), MSc in molecular medicine, postgraduate diploma in quality improvement and a PhD in molecular microbiology, all from Trinity College Dublin.