Planned EU regulation: Are additional rules overwhelming the medical technology sector?

The European medical device directive is currently at a turning point. It was initiated by the 2011 breast implant scandal. A French corporation had sold implants with cheap industrial silicone for years and even deceived inspection points. This incident newly aroused the debate over safety and transparency of the European medical device regulation.


Photo: Glasses lying on a thick book

The current draft law for the proposed EU regulation contains about 200 pages. For many companies, this flood of additional rules probably means the retirement of the market; © Richter

The trust in the CE mark is understandably severally shaken. After all, it appears to be easy to launch medical devices to market that do not fulfill the requirements. The reasons for this are varied. To this extent, the planned EU regulation amendment is intended to revise and replace the existing medical device directive for manufacturers. The goal is more safety and fewer risks.

“The current medical device legislation for manufacturers contains a manageable 30 pages and is intended to be replaced by an EU regulation in the future. We are currently looking at a 200-page bill with 97 articles and 16 annexes that is scheduled to be expanded by more than 60 enabling regulations,“ explains Manfred Kindler, publically appointed and accredited medical technology expert.

The extension stipulates an intensification in technical documentation and clinical evaluation, while requirements for certification organizations, so-called ‘Notified Bodies’ and regulatory authorities are also meant to be increased. Additional supervisory committees at the European level are also planned.

This sounds promising, but Kindler points out: “In the balancing act between striving for maximum safety and allowing the necessary room for innovations, the legislator is hopelessly caught up by the goal of achieving comprehensive guidelines for all medical devices. There are plenty of examples showing that too much regulation reduces safety levels.“

Photo: Lots of sticky labels cause confusion

Until a medical product gets on the market there are a number of hurdles. Unfortunately approval procedures already cause confusion at the national level and regulations are anything but standarized at international level; ©

Regulatory overkill instead of quality improvement

Potential regulatory overkill is not just a point of contention in terms of safety. Even before the directive has taken effect, it becomes apparent that the industry sector doesn’t consider intensification by including more products into the highest risk class as productive. Time and cost expenditures already exceed the available means of several companies.

“In the meantime documentation for product certification takes up half of the development process for one well-known German manufacturer,“ Kindler explains. The industry sector expects a significant cost increase during the implementation of the planned EU directive. This could affect smaller manufacturers particularly hard. Inevitably, they might have to forfeit some business units. Innovation potential would therefore be abandoned, since bureaucracy is not profitable in a dominant economic sector. “Neurosurgical niche products such as neuroendoscopy instruments for example have therefore in part already disappeared from the market,“ says Kindler.

If nothing else, the extent of the EU directive might lure people into simply marking off checklists. Test criteria could simply be checked off without critical analysis of the actual objective. Quality management then tends to become a mere formality.

For medical device operators, the documentation complexity also makes it increasingly more difficult to make an informed decision during the purchase, installation, use, maintenance and disposal.

“Aside from the possible loss of safety by overwhelming operators and users, patients need to worry about one significant disadvantage: the delay in introducing absolutely essential innovations thanks to increasing bureaucratic barriers. The implementation of new ideas and concepts is enormously constricted by regulationism,“ Kindler concludes.
Photo: Hand ticking of a check list

With the extent of the EU directive quality management tends to become a mere formality. Test criteria could simply be checked off without critical analysis of the actual objective; © Pippel

Creating more transparency and user friendliness

As a court-appointed expert, Kindler therefore requests political and legal measures that promote individual, free and independent thinking and action by manufacturers.

This initially includes a general reduction of formal guidelines in regulations. The focus should instead be on proving a true medical problem, and basic risk management that works with product and application-specific worst-case scenarios.

Regulators should already respond faster in case of suspicious activity to promptly identify weak spots. According to Kindler, this would also include an “increase in professional expertise of all parties involved, but particularly of regulatory authorities and the Notified Bodies.“ Kindler adds that the Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) also needs to show more transparency in terms of incoming notifications and notification handling, risk analysis, determining measures and controlling effectiveness.

In terms of criminal prosecution, Kindler also wants to see consequences come more quickly in the case of proven negligence. This could be implemented via public notices, recalls and penalties ranging all the way to closing down a company.

In addition, he recommends a kind of firewall for the commission of Notified Bodies by the manufacturer. Testing center are increasingly shaped by economic interests and often tend to award sweetheart deals. In addition federal, state and district jurisdiction should be combined. This could also include the reactivation of the ‘Federal and State Committee on Medical Devices‘ to coordinate all measures on the federal and state level.

Kindler also demands: “The EU Medical Device Directive should be viewed as an adaptive system and should therefore not be overloaded with details. A revision clause to check the system after three or five years would make sense.“ Until then, it remains to be seen what final form the EU directive will assume. There are currently more than 1,000 proposed amendments out there. This is why we should not count on the passing before 2016. 

Photo: Melanie Günther; Copyright: B. Frommann

© B. Frommann

Melanie Günther