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Open letter to European political institutions asks for transparency and collaboration as negotiations on a revised medical device framework near an end

11. March 2016 in News Newsletter Press Releases

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has today published an open letter sent to Members of the European Parliament (MEPs), the European Commission and Member State representatives, all of whom are negotiating the proposed revision to the legislative framework governing the approval and sale of medical devices in the European market.

Originally published in 2012, and now in the closing stages of the legislative process, the Commission’s proposal seeks to introduce wholesale changes to the regulatory system governing the manufacture, classification, clinical evaluation, and post-market surveillance of medical devices.

EUCOPE wrote to Member State representatives in May 2015 to both welcome and comment upon the Commission’s proposal. It has now written again – at this crucial juncture – to re-emphasise the critical importance of scientifically informed debate.

The so-called ‘trilogue’ negotiations in which members of the European institutions are currently engaged, are expected to draw to a close by June of this year, opening the way for a final agreement on this long-awaited piece of legislation.

Great progress has been made over the last few months, however there remain a small handful of issues yet to be fully resolved.

With this in mind, EUCOPE Secretary General, Dr Alexander Natz said:

“We at EUCOPE fully support the Commission’s intention to improve the safety of patients in Europe and we are pleased that trilogue negotiations have now well and truly begun. However we are still concerned that certain aspects of the file remain too ambiguous, jeopardising the stated ambition of the Commission’s proposal, namely: to be supportive of innovation and the competitiveness of the medical device industry and allow rapid and cost-efficient market access for innovative medical devices.

“We understand the need to address issues that have arisen as a result of past scandals. However, it is of the utmost importance that new powers, such as those to be awarded under the Commission’s proposed Article 3, are fair, transparent and consultative.

“EUCOPE strongly backs measures designed to ensure patient safety, but equally, if we are to ensure the continual supply of innovative new medical devices to European citizens, industry must be permitted a degree of certainty where regulatory decision-making is concerned. Were Article 3 for example, to be enacted as it currently stands, there exists no concrete guarantee in place to ensure that manufacturers are notified or consulted upon matters that may either directly or indirectly affect them – namely, the regulatory status of their products.

“EUCOPE would like to see a formal mechanism of consultation with industry included within Article 3, or at the very least, the insertion of a clear obligation to consult industry in Recital 8 of the legislation.

“The failure to write into the text of the proposal this duty on the part of the Commission to consult with interested parties upon the review of the regulatory status of a product or group of products is a significant oversight. We hope that it will be rectified in the coming weeks as actors across the three EU institutions come together to redefine the framework that is due to govern this industry for several years to come.”


Founded in 2008, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is Europe’s principal trade body for small-to-medium sized enterprises working in the fields of pharmaceuticals and medical devices. Representing over 900 companies across Europe, it is a recognised stakeholder by the EMA, HMA, European Commission and the European Parliament.

EUCOPE’s mission is to represent the interests of the sector in discussions with policy makers at both the national and international level in a fair, open and transparent way.

A copy of EUCOPE’s open letter to Member State representations can be found here.