Media Centre

Welcome to the Media Centre, which houses all news and announcements from MedTech Europe.

Press releases

Business groups express their continued support for TTIP negotiations

Brussels, 5 September 2016 – The undersigned trade associations reiterate their strong support for the ongoing negotiations for a Transatlantic Trade and Investment Partnership (TTIP). Both the European Commission and the U.S. Trade Representative have underlined that the TTIP negotiations remain on track and that intensive efforts are ongoing to conclude an ambitious agreement. Business groups on both sides of the Atlantic remain ready and willing to engage with all stakeholders to support these efforts.

EDMA welcomes new Executive Committee

The European Diagnostic Manufacturers Association (EDMA) elected a new Executive Committee at the EDMA General Assembly held last 2 December 2015 at the Dolce La Hulpe in Belgium.

Eucomed board welcomes new members

Eucomed, the European Medical Technology Industry, elected new board members last 2 December 2015 at the Eucomed general assembly held at the Dolce La Hulpe in Belgium.

The general assembly elected six new members to the Eucomed board:

MedTech Europe encouraged by Council discussions

Brussels, 19 June 2015 - MedTech Europe, the alliance of Eucomed and EDMA, welcomes the fact that the Council has opted to move forward with its proposal. At the same time, MedTech Europe notes that Council also recognises a number of areas that still raise concern and thus warrant further work.

Does my app look big in this?

New EU expert think-tank seeks to answer the question, “what constitutes best-in-class standards of clinical evidence for innovative medical technologies and apps.”

Global Medical Technology Alliance gains WHO recognition

Brussels, 9th February 2015 – World Health Organization (WHO) has recognized the Global Medical Technology Alliance (GMTA) as a non-governmental organization (NGO). This recognition reflects the growing value of medical technology in the deployment of essential health policies and programmes around the world.

EDMA welcomes new Executive Committee

Brussels, 4 November 2014 – The Executive Committee of EDMA, the European Diagnostic Manufacturers Association, today announces the election of Philippe Jacon of Cepheid; Christian Parry of Stago representing SIDIV the French National Association for IVDs; Paul Arnaoutis of Paul Arnaoutis S.A. representing SEIV, the Greek National Association for IVDs; Vicky Voulgaraki of Thermo Fisher Scientific; Michael Heuer of Roche Diagnostics; Nadav Tomer of Johnson & Johnson; John Coulter of Abbott Diagnostics; Tadeusz Tuora of Cormay representing IPDDL, the Polish National Association for IVDs and Lorenzo Fracassi of Dasit representing Assobiomedica, the Italian National Association for IVDs to the EDMA Executive Committee.

Eucomed Board welcomes three new members

Brussels, 3 November 2014 – Eucomed today announces the election to its Board of Directors of Diogo Moreira-Rato, Group President, Europe and Canada, Smith & Nephew; Dr Riad Sherif, Area President EMEA, Alcon; and Assobiomedica, the Italian medical technology industry association, represented by Gabriele Mazzoletti. The new Board members were elected to fill positions vacated by Stéphane Thiroloix, former President Advanced Surgical Devices Europe, Smith & Nephew; Miguel Bernabeu, Head Market Access Eurmea, Alcon; and Danish medical technology industry association Medicoindustrien, represented by Louise Feilberg Levy.

European Forum for Good Clinical Practice and MedTech Europe establish joint "Medical Technology Working Party"

Brussels, 4 September 2014 – The European Forum for Good Clinical Practice (EFGCP) and MedTech Europe, the alliance of European medical technology industry associations, today announce the establishment of a joint Medical Technology Working Party within EFGCP aimed at addressing ethical and quality issues when setting standards for clinical evaluation in the medical technology sector.

Eucomed welcomes Commission conclusions on joint plan for immediate actions for medical devices

Brussels, 18 June 2014 - Eucomed, the European medical technology industry association, today welcomes the release of a Commission Staff Working Document which outlines progress on the Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices Directives. The Commission’s assessment confirms that much needed improvements to Europe’s notified body system have been successfully implemented and are already yielding tangible results. The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation

Eucomed Ethical Business Logo Programme now open to non-Eucomed members

Barcelona, 21 May 2014 – MedTech Europe, the alliance of European medical technology industry associations, announces today the extension of the successful Eucomed Ethical Business Logo Programme to non-Eucomed members. The programme allows any MedTech company to have its compliance governance benchmarked against the industry standard. In a verification process designed with guidance from one of the Big Four global accounting firms, companies must demonstrate their commitment to ethical principles outlined in the Eucomed Code of Ethical Business Practice. The Logo serves as a visible signal to the outside world that a company is serious about compliance.

Eucomed receives fund of USD 846.000 from the Siemens Integrity Initiative to promote good compliance procedures in the Middle East & North Africa region

Brussels, 11 March 2014 - In 2013, Eucomed responded to the Siemens Integrity Initiative by presenting a project that proposed to extend the scope of the Conference Vetting System (CVS), to the Middle East & North Africa (MENA) region. On 23 February 2015 Eucomed’s application was accepted and Eucomed received a fund of 846.000 USD over a period of three years to set up the project.

European IVD Industry Welcomes Plenary Vote But Remains Concerned with the Three-Year Transition Period

Brussels, 22 October 2013 – EDMA, European Diagnostic Manufacturers Association, welcomes the key changes in the regulation adopted today in a plenary vote by the European Parliament on the Proposal for a Regulation on in vitro diagnostic (IVD) medical devices. Members of the Parliament have voted for the adoption of the new classification for IVDs, stronger requirements on clinical evidence, new mechanisms for the control of notified bodies, and the implementation of a new unique device identification system. The industry also welcomes the adaptation of the scrutiny process to the reality of the regulation of IVDs. In particular, this adaptation introduces criteria, which are specific to IVDs and considers that IVDs have already been subject to the additional assessments required for compliance with the Common Technical Specifications. However, the European in vitro diagnostics industry remains concerned at the decision to shorten the transition period from five to three years.

European IVD industry welcomes plenary vote but remains concerned with the three-year transition period

Brussels, 22 October 2013 – EDMA, European Diagnostic Manufacturers Association, welcomes the key changes in the regulation adopted today in a plenary vote by the European Parliament on the Proposal for a Regulation on in vitro diagnostic (IVD) medical devices. Members of the Parliament have voted for the adoption of the new classification for IVDs, stronger requirements on clinical evidence, new mechanisms for the control of notified bodies, and the implementation of a new unique device identification system. The industry also welcomes the adaptation of the scrutiny process to the reality of the regulation of IVDs. In particular, this adaptation introduces criteria, which are specific to IVDs and considers that IVDs have already been subject to the additional assessments required for compliance with the Common Technical Specifications. However, the European in vitro diagnostics industry remains concerned at the decision to shorten the transition period from five to three years.

European Parliament improves committee report, paving the way to achieve balanced EU rules on medical devices

Brussels, 22 October 2013 - Eucomed, the European medical technology industry association, welcomes the majority of measures adopted today in a plenary vote by the European Parliament on the revision of the EU Medical Devices Directive (MDD). Members of the European Parliament (MEPs) have voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement. On the approval system for medical devices, Eucomed positively notes that Parliament has shifted the approach and direction to a more manageable process without compromising the shared goal of improving patient safety. On the reprocessing of single-use medical devices, by adopting a variety of different elements, some newly introduced at Plenary, the approach taken still leaves significant concerns for patient safety as well as legal inconsistencies. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the European Parliament’s stated desire to install a high level of patient safety throughout Europe. All in all, Eucomed believes that this vote will send a strong signal towards Council that Parliament is interested in finding a balanced, implementable solution that guarantees both better patient safety and a vibrant and innovative MedTech sector.

Jürgen Schulze, EDMA President, elected new Chairman of MedTech Europe Board

Brussels, 11 October 2013 – MedTech Europe’s Board of Directors has announced today that Dr. Jürgen Schulze, EDMA President and CEO and President of SYSMEX EMEA, has been elected Chairman of the Board of MedTech Europe. MedTech Europe is the alliance of European medical technology industry associations. The alliance is currently made up of EDMA, the In Vitro Diagnostics Manufacturers Association, and Eucomed, the European Medical Devices Industry Association. In this role, Dr. Schulze will succeed Guy Lebeau MD, Johnson & Johnson Group Company Chairman Medical Devices & Diagnostics EMEA, who will be stepping down as Chairman of the MedTech Europe Board effective immediately.

Jürgen Schulze re-elected EDMA President

Brussels, 11 October 2013 – The Board of Directors of EDMA, the European In Vitro Diagnostics Manufacturers Association, has announced today that Dr. Jürgen Schulze, EDMA President and CEO and President of SYSMEX EMEA, has been re-elected EDMA President.

Rob Ten Hoedt elected Chairman of the Board of Eucomed

Brussels, 11 October 2013 – Eucomed’s Board of Directors has announced at its Annual General Assembly that Rob ten Hoedt, Medtronic Senior Vice-President & President, Europe, Middle East & Africa and Canada (EMEAC), has been elected Chairman of the Board of Eucomed. In this role, Mr. ten Hoedt will succeed Guy Lebeau MD, Johnson & Johnson Group Company Chairman Medical Devices & Diagnostics EMEA, who will be stepping down as Chairman of the Eucomed Board effective immediately. Dr. Lebeau has been named Honorary Chairman of the Eucomed Board.

Medtech industry is making switch to value-based innovation

Brussels, 10 October 2013 - The Executive Summary of research by Boston Consulting Group (BCG) and MedTech Europe, an alliance of European Medical Technology Industry Associations, indicates that the medical technology industry in Europe is changing the way it is doing business and is progressing towards making value-based innovations available to patients. By focusing on the value of its technologies, the medtech industry is contributing to steering Europe's healthcare systems onto a sustainable path. MedTech Europe will continue to inform on the importance of executing the MedTech Industry's 5-Year Strategy. The Executive Summary was launched today at the European MedTech Forum 2013 and precedes the full report which will be available by mid-November on reforminghealthcare.eu.

From IVD directive to regulation: Gathering scientific data takes time

Brussels, 25 September 2013 –The European in vitro diagnostic industry appreciates the outcome of the vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI) but takes note of the Committee’s decision to provide a transition period of only three years. The change to the new classification and the implementation of clinical evidence will potentially require manufacturers to go back to gather data on new studies. EDMA, the European in vitro diagnostic industry association, believes that the optimal transition period for the new IVD regulation is five years as gathering scientific data takes longer than the proposed period.

Rushed deal leaves patients and jobs in second place

Brussels, 25 September 2013 - Eucomed, the European medical technology industry association, expresses disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI). The Committee has voted in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system. The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers. The ENVI committee compromises patients and jobs in a what looks like a rushed through deal that seeks to satisfy the time pressure that Parliament feels ahead of the European elections, but not the needs of Europe’s patients and doctors. For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014. It is now up to the political groups in light of the plenary vote in October to turn the “rushed deal” into a “right deal” for patients and jobs.

€ 17.5 billion for unnecessary measures will be a blow to medical device innovation in Europe

Brussels, 12 September 2013 – The results of a survey amongst medical device companies in Europe about the financial impact of the upcoming changes in the European medical device regulation show a significant increase in costs for bringing new devices to patients. In addition to the necessary € 7.5 billion investment to ensure the safety of patients, a shocking additional € 17.5 billion would be necessary to finance a centralised pre-marketing authorisation system as proposed by the European Parliament’s Rapporteur. Research shows that such an authorisation system does not improve patient safety and makes patients wait unnecessarily 3-5 years before receiving lifesaving medical devices. The result of such an enormous unnecessary increase in costs will most likely be a drain of innovation and leaving Europe with less SMEs, jobs and less R&D capabilities, ultimately leading to less treatment options for patients.

New ESC guidelines confirm effectiveness of remote monitoring in cardiac pacing and resynchronization

Brussels, 4 July 2013 - Eucomed, the European Medical Technology Industry Association, welcomes the update to class IIa with level of evidence A for device-based remote monitoring in the ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy (CRT). Class IIa therapies are treatments which are found to be useful and effective. The updated class not only reflects research findings which conclude that remote monitoring could help patients at high risk for stroke, but also follows a recent consensus between joint European and American experts on the benefits of remote monitoring for patients with a CRT device.

Medical technology industry applauds announcement to start US-EU trade negociations

Washington, D.C., 20 June 2013 – Today, the leading global medical technology industry associations AdvaMed, COCIR, MITA and MedTech Europe (the alliance of European medical technology industry associations EDMA and Eucomed) applaud the announcement to launch trade negotiations between the United States and European Union.

No systematic link between medtech innovation and increase in healthcare expenditure

Brussels, 11 June 2013 - MedTech Europe, the alliance of European Medical Technology Industry Associations, welcomes new research from the European Health Technology Institute (EHTI) confirming that there is no uniform relationship between medtech innovation and an increase in healthcare expenditure. The impact of medical technology on healthcare costs is a result of multiple, dynamic factors, such as whether a technology expands the number of treatable conditions, improves the capacity of the system to treat more patients, or extends life, inducing additional years of healthcare consumption. Consequently this impact varies greatly and can result in novel technologies being cost-saving, cost-neutral or cost-increasing.

European Cardiologists recognize contribution of medical device industry to improving patient care

Brussels, 23 May 2013 – The European cardiovascular medical device industry was presented on 20 May at the annual meeting of the European Association for Percutaneous Cardiovascular Interventions with the Ethica Award for its contribution to improving European patient care. Interventional cardiologists use narrow tubes, or catheters, passed through arteries or veins to reach the heart or other organs to carry out procedures and insert devices to treat disease. The award recognizes the role played by safe, innovative cardiovascular devices in addressing unmet medical needs and improving patient survival rates and quality of life.

Medical technology industry calls for regulatory convergence in U.S.-E.U. trade deal

Washington, D.C., 12 April 2013 – The medical technology industry represented by AdvaMed, COCIR, Eucomed, EDMA and MITA met yesterday with senior U.S. and E.U. government officials as part of the U.S.-E.U. High Level Regulatory Cooperation Forum urging them to consider regulatory convergence for medical technology in upcoming negotiations on the Transatlantic Trade and Investment Partnership (TTIP).

Public debate in European Parliament on future EU medical device legislation focused on the need for safety and timely access

Brussels, 28 February 2013 – Eucomed, the European medical technology industry association, welcomes stakeholder calls at a public hearing of the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 26 February, for much needed improvements to Europe’s regulatory system for medical devices. Physicians, patient groups and industry made clear their desire for a system that improves patient safety, protects patient access to life-saving medical technology and increases transparency and device traceability. Various stakeholder groups noted that a centralised authorisation system for high risk devices would not lead to the desired increase of safety and bring unnecessary delays in patient access of medical technologies. Research shows that a centralised system does not increase safety and patients subject to such a system wait on average at least three years longer for receiving life-saving medical devices compared to patients in Europe.

Early hip replacement cost-effective

Brussels, 7 February 2013 - Delaying Total Hip Replacement surgery (THR) in people with osteoarthritis (OA) as a way to cut costs is ineffective and denies patients the benefits of an active and healthy life. Moreover, young adults do not benefit from postponing the treatment to avoid revision surgery in later life as the majority of younger people will never have to undergo revision surgery with current technology.

Public debate in European Parliament on future EU medical device legislation focused on the need for safety and timely access

Brussels, 28 February 2013 – Eucomed, the European medical technology industry association, welcomes stakeholder calls at a public hearing of the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 26 February, for much needed improvements to Europe’s regulatory system for medical devices. Physicians, patient groups and industry made clear their desire for a system that improves patient safety, protects patient access to life-saving medical technology and increases transparency and device traceability. Various stakeholder groups noted that a centralised authorisation system for high risk devices would not lead to the desired increase of safety and bring unnecessary delays in patient access of medical technologies. Research shows that a centralised system does not increase safety and patients subject to such a system wait on average at least three years longer for receiving life-saving medical devices compared to patients in Europe.

Members of the European Parliament identify in vitro diagnostics as parent of healthcare

Brussels, 28 February 2013 – On Tuesday, 26 February, European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) held a public workshop to exchange views on the in vitro diagnostics medical devices proposal in Europe. Policymakers, industry leaders, medical professionals and healthcare stakeholders unanimously highlighted the role of in vitro diagnostics as the “parent” of healthcare.

European medtech industry recommends additional measures to be included in the EU medical device legislation proposal

Brussels, 31 January 2013 – The European medical technology industry, through its industry association Eucomed, has responded in detail to the European Medical Device Directive proposal. Industry welcomes many of the recommended measures but unanimously agrees that improvements in seven key focal areas are necessary to guarantee the delivery of safe, innovative medical technology that European patients, doctors and healthcare systems need. In particular it recommends a “systematic control procedure” consisting of seven critical measures as an alternative to Commission’s proposed scrutiny procedure. The systematic control procedure will more effectively achieve the common objective of increased patient safety. The seven measures would replace the Commission’s proposed scrutiny procedure, which industry finds inappropriate as it is random, ineffective and does not contribute to patient safety.

Eucomed statement on PIP breast implant incidents

Brussels, 9 January 2012 – The European medical technology industry association Eucomed notes with great concern recent press reports that the French firm Poly Implant Prothèse (PIP) may have violated the regulations by using unapproved industrial-grade silicone in some of its implantable