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.“
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.