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ESC responds to European Commission's Proposals for new regulation to govern medical devices

The priority must be to ensure patient safety

ESC authors have outlined five suggestions that they feel would make the EC legislation stronger: a requirement to establish the clinical efficacy of certain new high-risk devices; greater transparency; a formalized European system for obtaining expert scientific and medical advice; specialisation of Notified Bodies evaluating high-risk medical devices; and the establishment of independent post-market surveillance.

Sophia Antipolis, 8 March 2013. In a position paper¹, the European Society of Cardiology (ESC) welcomes the European Commission’s (EC’s) proposals for a new Regulation to govern the evaluation and approval of medical devices in Europe² as an important step towards improving patient safety.
The position paper, coordinated by the ESC Task Force on Medical Devices, comes as the European Commission proposal is being considered by The European Parliament and The Council of the European Union. The ESC authors have outlined five further suggestions that they feel would make the legislation stronger:

  • a requirement to establish the clinical efficacy of certain new high-risk devices
  • greater transparency
  • a formalized European system for obtaining expert scientific and medical advice
  • specialisation of Notified Bodies evaluating high-risk medical devices
  • and the establishment of independent post-market surveillance
“To protect patients it’s important to achieve a balance between over-regulation that thwarts innovation and the release of devices that haven’t been properly evaluated,” said ESC President Professor Panos Vardas, who co chairs the ESC Task Force on Medical Devices. “We feel that cardiologists are particularly well placed to play a greater role in device regulation. We are among the main users of permanently implanted medical devices for our patients, and have a good appreciation of what risks are considered acceptable and how devices should be evaluated from a clinical perspective.”

In its position paper, the ESC particularly welcomes the unification of the directives into a single regulation, increased coordination between the national competent authorities, and the enhanced quality control of Notified Bodies. Inclusion of the five amendments, the ESC felt, would help to maintain access for patients to new devices while also ensuring a high level of protection of public health.

“Overall for doctors to be able to practice good evidence-based medicine when using devices, we feel that more clinical trials need to be undertaken to establish efficacy, and that far more information needs to be made available in the public domain,” said Professor Alan Fraser, co-chair of the ESC Task Force on Medical Devices.

Further recommendations from the ESC include:

1. Patient safety and clinical evaluation

When advised by independent medical experts, the ESC recommends that the approval process for high risk class III implantable devices should require randomized clinical trials. Furthermore, when new class III high-risk cardiovascular devices are proposed as alternatives to existing safe and effective devices, the ESC feels they should not be approved on the basis of equivalence to existing devices. “In such circumstances we think independent experts should decide on the need for a trial,” said Prof Fraser.

2. Transparency

The ESC believes that a summary document prepared by the manufacturer (as proposed in the current draft Regulation) is insufficient, and that open access should be made available to all data submitted by the manufacturer in its dossier prepared for the Notified Body, the subsequent evaluation by the Notified Body, and conclusions of the relevant national competent authority concerning any clinical trials.
Granting doctors access to such information, argued the ESC authors, complements peer-reviewed scientific literature, and is essential for comparing alternative devices within any class. “This would be in line with the increased amount of information now being made available for clinical trials of drugs in Europe,” said Prof Fraser. The only exception to the policy, write the ESC authors, would relate to manufacturing details protected by intellectual property.

3. Expert advice

With medical devices becoming ever more sophisticated, the ESC believes that a “systematic mechanism” should be established for obtaining detailed independent expert professional advice.
Expert advice would be needed from wide spread disciplines including materials scientists, physicists, engineers, informatics specialists and clinical scientists. Professional organizations, such as the ESC, could play an important role in helping identify the relevant independent experts.

4. Notified Bodies

While the ESC welcomes the EC’s proposals to strengthen the supervision of Notified bodies, they feel that the legislation could go further to ensure that high-risk medical devices are evaluated only by Notified Bodies with proven expertise in evaluating the specific type of device under consideration. “This would prevent expertise from being diluted and ensure devices received the best possible evaluation,” said Prof Fraser.

5. Post-market surveillance

In recognition that new devices may be associated with unforeseen adverse events, some of which may become apparent only during long-term follow-up, the ESC has called for reform of the system of post-market surveillance. The ESC proposes independent registries, with prospective and complete follow-up of all patients for a pre-specified period after approval, and standardized collection of data. “It could for example be done through registry programmes organized by medical associations, such as the ESC’s EuroObservational Research Programme which now has more than 50,000 patients enrolled,” said Fraser.
The ESC has proposed that the concept of conditional approval should be included in the Regulation, where competent authorities can specify that continued access to the market for a particular device is made dependent on the manufacturer collecting further evidence of its clinical efficacy. This strengthened post-market evaluation would complement early access to the market for new medical devices that meet a clinical need. Cardiologists and academic engineers work with manufacturers to develop and evaluate new devices, and the ESC considers that such collaborations are essential. “Conditional approval would be one way to support innovation without burdensome over-regulation, while ensuring the safety of patients,” said Professor Fraser.
The current time table for legislation includes review of the proposals by Rapporteur MEP Dagmar Roth-Behrendt from the Committee on Environmental, Public Health and Food Safety (ENVI), with a draft report scheduled for 24 April 2013, and the deadline for amendments 3 May 2013. The European Parliament and European Council hopes to vote in 2013, with the legislation taking effect in around five years.


Background to the device proposals

The European Commission announced its proposals for new Regulation to govern the evaluation and approval of medical devices in Europe in September 2012². The proposals were against a background of concerns being raised that the current system for testing and approving devices in Europe, established more than 20 years ago, needed to adapt to technological advances and changing patterns of medical practice.
The ESC has played a vital role in highlighting the complexity of the current system of the European medical device regulation which is the responsibility of the 27 member States of the European Union (EU), each of which has its own national “competent authority”. Devices are assigned to four groups according to their perceived risk before they are approved (class I, class IIa, II b, and III). Any manufacturer wishing to obtain approval to market a new device in classes IIa, IIb or III must undergo a conformity assessment procedure by one of the 77 Notified Bodies (NBs) in Europe dealing with medical devices, many of which are independent commercial organizations. Once the NB has reviewed the technical dossier submitted by the manufacturer and completed its evaluation of the application, it then issues a certificate that permits the manufacturer to affix a CE mark and to market the device throughout the EU.
The ESC has been actively involved in campaigning for device legislation reform. In January 2011 the ESC held a policy conference at Heart House, attended by around 50 delegates, to allow the international cardiology community to share their views. The conference highlighted the system where manufacturers must satisfy the relevant “essential requirements” of safety and performance, but do not need to establish that their devices have an impact on clinical outcomes, even if it is a completely new technology³. Furthermore, the ESC published papers about the need for reform in the BMJ⁴´⁵.
More recently, on 26 February 2013, Professor Panos Vardas, the ESC president, spoke at the European Parliament’s workshop on the Commission’s proposed Medical Device and IVD Regulations ⁶.

“The ESC welcomes many provisions in the draft regulation and recognises the progress that has been made to improve the regulatory system in the interests of safety for patients in Europe and beyond. Patient safety is the priority,” he said.

As well as medical input, the workshop offered insights from industry, regulators, patients and the media. The material from the meeting will be used by MEP Dagmar Roth-Behrendt to prepare her report on the medical device proposal, for which she is rapporteur for the European Parliament’s committee on Environment, Food, and Public Health (ENVI).
In Europe there are estimated to be around 200,000 different types of medical devices, produced by more than 11,000 companies, which employ more than half a million people and have combined annual sales of more than €72 billion.
With the opening of its new Brussels bureau last month, the ESC is well placed to influence European affairs.

“The European Heart Agency should allow us to establish better links with politicians, become more active in the decision making process, and ultimately help to reduce cardiovascular disease, which is the biggest killer in Europe,” said Prof Vardas.


1. European Society of Cardiology. Position on the recast of the European Union Medical Devices Directive.
2. European Commission. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 1223/2009. Brussels, 26.9.2012, COM(2012) 542 final,
2012/0266 (COD).
3. A Fraser, J Daubert, F Van de Werf et al. Clinical evaluation of cardiovascular devices: principles, problems and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology. Eur Heart J 2011;32: 1673-86.
4. Fraser AG, Krucoff MW, Brindis RG, Komajda M, Smith SC Jr. Commentary: International collaboration needed on device clinical standards. BMJ. 2011;342:d2952.
doi: 10.1136/bmj.d2952.
5. Di Mario C, James S, Dudek D, Sabate M, Degertekin M. Commentary: The risk of over-regulation. BMJ. 2011;342:d3021. doi: 10.1136/bmj.d3021.
6.Prof Vardas at the EU Parliament:


Notes to editor

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 80,000 cardiology professionals across Europe and the Mediterranean.  Its mission is to reduce the burden of cardiovascular disease in Europe.