Upcoming new medical device regulations in the EU and their impact on medical device safety and vigilance

In our safety and pharmacovigilance focus month, just how important is it to have a policy for medical devices? Marc Pignot, Christian Schübel, Alfred Pauls, Klaas Heinemann discuss their expectations for the new medical device regulations, ahead of the European Parliament’s decision this week.

On July 10, the European Environment, Public Health and Food Safety (ENVI) committee of the European Parliament will make a decision about new medical device regulations; the effect of these regulations on medical device safety and vigilance is of significant importance to Europe. Politically, the pressure for this regulation is very high due to a number of medical device scandals that have resulted in a heightened focus on patient safety and intense lobbying on both sides. With the European Parliament likely to decide on the regulation prior to the elections in autumn 2014, better understanding the impact of these regulations on the healthcare industry is crucial.

“Currently, no approval process exists for bringing a medical device to the European market from any competent authority.”


Currently, no approval process exists for bringing a medical device to the European market from any competent authority. A competent authority (such as the Federal Institute for Drugs and Medical Devices in Germany) is an independent federal authority within the member state’s country and associated with its federal ministry of health. To gain market access, a conformity assessment must be performed by a notified body, which is a nationally accredited group that conducts the conformity evaluation of the production process on behalf of the manufacturers. The result is in a CE marking, a mandatory conformity marking for products sold in the European Economic Area (EEA). Once the product receives its CE mark, it can be sold on the European market. Developed over 20 years ago, the CE mark system is less stringent than that of the U.S.; however, the simpler process brings products to market quicker, benefiting both the manufacturer and the patient.

What to expect with the new regulations

The upcoming changes mean the EU is moving away from a directive required by national law, to a regulation, which seeks to deliver better harmonization in Europe for medical devices. For the class III devices (high-risk devices such as cardiovascular catheters, spinal stents or prosthetic heart valves) waiting to be certificated, a scrutiny procedure involving competent authorities needs to be implemented and additional clinical trials performed to achieve better harmonization.

Previously, it was possible to bring devices to market based on the principle of equivalence, meaning that if a company could show that their device was equivalent to an established device it was possible to use published clinical data to get the new device to market. The new regulations would withdraw the principle of equivalence and require further clinical trials in medical devices, which would especially affect class III devices.

The MEDDEV guidance document on post-market clinical follow-up (PMCF) activities applies to post-marketing activities. This guidance is not legally binding, and much of its content is expected to be implemented directly in the new regulations.

The revised regulation will force manufacturers to perform studies after they receive a CE marking. Post-marketing studies will need to have a clear focus on safety and vigilance, especially for all class III devices, for which an approval process also is being discussed for these products. According to the draft regulations from the European Parliament, they are now moving away from the responsibility being on the manufacturer to the responsibility being on the competent authorities. What is important to understand is the fact that currently there is a clear distinction between the approval process which relies on notified bodies – private organized test houses – and the vigilance and post market surveillance, which is in the responsibility of the competent authorities. It is planned to involve the authorities in the approval of implants and high risk devices (class III) additionally.

“There is now a clear move toward improving the patient safety profile to better reflect the medical device area.”

Nevertheless, the requirements to perform these PMCF studies will not change. A requirement will come to be enforced regardless of whether there is an approval or a certification of medical devices.

Drivers of change

The scandals in the EU related to breast implants and hip replacements were a major driver for regulatory bodies to think about the current procedures and to initiate change. There is now a clear move toward improving the patient safety profile to better reflect the medical device area. This trend could lead to demonstrating what is considered already established practice in the pharmaceutical industry, enabling companies to better demonstrate safety and effectiveness for patients.

One additional driver is based on the experience of the competent authority with the independent notified bodies. No harmonized procedure currently exists to assess the quality of the conformity assessment done by notified bodies. Therefore, the Commission and the European Parliament are seeking to harmonize the assessments, reduce the number of notified bodies, and implement a harmonized certification procedure to increase its quality. Another important aspect is that medical device manufacturers would have to prove patient benefit to demonstrate — particularly for class III devices — their effectiveness, which is currently also under discussion in the medical device area. Clearly the changes are focused on demonstrating effectiveness, proving patient benefit and, most importantly, guaranteeing patient safety.

What are the implications for medical device companies?

It is anticipated that all these committees and approval processes will become very similar in the devices industry, much like the pharmaceutical industry. The question is in the timing.

A key factor will be the additional requirements for post-marketing studies. Most importantly, studies required for safety and vigilance will have a significant impact on medical device companies. They will have to be engaged in safety surveillance programs to better support product safety, which was lacking due to a very stringent and legal environment. Furthermore, it is estimated that more emphasis will be put on registry and PMCF studies for medical devices.

Vigilance and safety patient-centric studies are a superior approach to patient registries. One important advantage of patient-centric safety surveillance and vigilance studies is that they not only look into expected side effects but also unexpected side effects. If asking a patient about adverse events during a specific period, the patient would not usually know what could be associated to the device and / or the procedure. These reported events then must be validated by the diagnosing and / or treating physician and the potential association with the device will be evaluated.

“Be prepared, not only for post-marketing studies, but also for developing defence strategies.”

Another very important factor is that the regulations will require supervision of the notified bodies. Therefore, the authorities’ inspections of the notified bodies will focus more on what the notified body is doing to guarantee that the product on the market is supervised, evaluated and accurately assessed.

Reimbursement is also a key driver. Political authorities believe that the data generated for the CE marking are too sparse to support reimbursement. Additional value studies after CE marking are necessary to support and gain reimbursement, which is, of course, not regulated across Europe but rather on a national or member-state level. These could be pre-launch studies or post-launch studies to demonstrate a clear value and patient benefit to get a reasonable or favourable reimbursement or price for the product. Indirectly, these will be covered by the new regulation and will pose an additional burden on device manufacturers.

Be prepared, not only for post-marketing studies, but also for developing defence strategies.

A critical implication – the question of liability – lays, to a certain extent, outside the regulations. Independent of regulations, manufacturers should be aware that they have to proactively make a demonstrable effort to ensure that their devices are safe and effective for the patient. Currently, the medical device industry appears to be underestimating the need to answer possible liability questions, but this debate will further emerge due to the changes in the regulations and legal requirements. It is only a matter of time until this sort of close supervision will be implemented, in effect closing the loopholes. The medical device industry, in general, does not currently see the benefit of the regulations that — if implemented and followed — can save them from future trouble.

The liability issue is a general problem that can easily ruin a large company. Therefore, it is unavoidable in the future to implement defence strategies if politics continue to weed out unsatisfactory products. With respect to liability, if an issue arises and a company has not prepared a defense strategy or does not have any data to respond to the liability issues, it will face a very difficult situation.

About the authors:

Marc Pignot, PhD, Senior Director at Kantar Health, is responsible for the Medical Device & Diagnostics business. Dr. Pignot is a Health Professional with more than 12 years of experience in the medical device, diagnostic and pharmaceutical research business. He earned his PhD in Bio-Organic Chemistry from the Max-Planck-Institute of Molecular Physiology and did his postdoctoral training at the University of Frankfurt.

Christian Schübel, MD, PhD, Head of Clinical Affairs at iDRAS. iDRAS is the expert regulatory consulting company in Germany and a collaborator of Kantar Health. Christian trained as a physician and after many years in practice, joined the TÜV as a Notified Body; where he was the Head of the Clinical Affairs Department, responsible for clinical evaluations, clinical data assessment for medical devices.

Alfred Pauls, MD, PhD, Senior Consultant to ZEG, has a license to practice medicine and is board certified for internal medicine. He is also a board certified specialist in Sexology and Sexual Medicine who is involved in the design and conduct of several studies in his field of expertise. He was the former Head of Corporate Drug Safety and Liability, as well as Head of Clinical Development at a large pharmaceutical company, where he focused on methodological approaches to clinical and epidemiological research including establishment of reporting systems for (serious) adverse event reporting.

Klaas Heinemann, MD, PhD, MSc, MBA, has a medical degree and received training in internal medicine and cardiology. He received a degree in Business Administration (MBA) at Berlin School of Economics and a Masters degree in Epidemiology at London University / LSHTM. He worked as medical consultant at the Berlin Center for Epidemiology & Health Research (ZEG-Berlin) for years before he finally joined this institute in 2009 as Managing Director. In between he worked at a large pharmaceutical company (Berlin and New Jersey -US) from 2004 to 2009 and gathered experience as Medical Expert in Global Medical Affairs in planning and managing clinical research particularly in Phase III and IV.

ZEG-Berlin is a Kantar Health company specializing in many kinds of pharmacoepidemiological and safety studies, including device safety studies.

How will the new regulations affect medical device companies in Europe?