Heart specialists call for single EU system to approve medical devices

A single co-ordinated European system is needed to oversee the evaluation and approval of medical devices and drive higher standards, according to the European Society of Cardiology (ESC). This could be set up as a medical devices arm of the European Medicines Agency (EMA), or as a new and separate body.

“The ESC believes that the approval of devices used in medicine shares similarities in terms of ethical responsibilities, [with] the approval of new drugs,” said Michel Komajda, the ESC President.

The current system for testing and approving devices in Europe was established more than 20 years ago, and concerns have been raised that it needs updating to take account of new technology and changing patterns of medical practice.

Currently the manufacturers of medical devices must satisfy safety and performance requirements but do not need to establish a device has an impact on clinical outcomes, even if it uses a completely new technology. Instead - unlike new drugs - the manufacturers of medical devices are allowed to use surrogate or functional endpoints in clinical studies.

“Standards of testing of medical devices are less rigorous in Europe than the US, where they have to undertake trials to show that the device has an impact on clinical outcomes, with the reality that European patients are currently exposed to an unfair proportion of the risks associated with developing new devices,” said Alan Fraser, of the ESC.

Fraser chaired an ESC policy conference on the issue in January, attended by around 50 delegates including experts from the ESC, the American College of Cardiology, American Heart Association, the World Heart Federation, the European Commission, the US Food & Drug Administration, and representatives from the medical devices trade bodies Eucomed and COCIR. The conclusions of the conference have been published this week.

Taking the example of balloon angioplasty to illustrate the level of testing currently required, Fraser noted that manufacturers in Europe need only establish that the diameter of an artery is greater following the procedure, or that a new balloon is equivalent to other balloons already on the market, and not that there is any impact on clinical outcomes, such as mortality.

It is estimated that around 200,000 different types of medical devices are registered in Europe. These are 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.

The ESC is calling for a single co-ordinated European system to oversee the evaluation and approval of medical devices, as the most efficient way of achieving integration and harmonisation of processes between regulators to ensure they apply uniform and higher standards.

The ESC’s paper highlights the complexities of the current system of 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 regulator.  Unlike the EMA, where companies can submit a single application for authorisation by the European Commission and marketing throughout Europe, there is no single, common European agency for assessing devices.

The complexity is multiplied by the fact that devices are assigned to four groups according to their perceived risk before they are approved –  low-risk cardiovascular devices such as stethoscopes are in Class I; Class  IIa, includes devices for monitoring blood pressure and diagnostic equipment; Class IIb includes diagnostic radiology equipment such as X-ray machines; and  Class III includes implantable devices such as coronary stents, prosthetic heart valves and defibrillators. 

Any manufacturer wishing to obtain approval to market a new device in classes IIa, IIb or III must undergo assessment by one of the 74 so called Notified Bodies (NBs) in Europe dealing with medical devices. Many of the NBs are independent commercial organisations. Once the NB has reviewed the device it issues a certificate permitting the manufacturer to affix a CE mark and to market the device throughout the EU.  

For devices in Class III, the manufacturer must conduct some human clinical investigations, but it is not compulsory that these are randomised clinical trials.

There has never been a published audit of NBs and the ESC says this gives rise to suspicions that manufacturers select the NB that will conduct the least burdensome or the fastest review.

Reference: Fraser AG, Daubert  JC, Van de Werf F, 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. European Heart Journal. Doi 10.1093/eurheartj/ehr171.