Professor Gets Primer on Medical Device Regulation from BVMed

“Medical devices are not subject to any regulatory approval; [manufacturers] don’t have to prove their effectiveness nor their safety.” Would you believe that’s what Professor Juergen Windeler, future head of the Institute for Quality and Economic Efficiency in Healthcare (IQWiG), claimed in an article published on 10 June in the German weekly news magazine Stern? German medical technology association BVMed felt compelled to respond. In a letter to the editor of Stern, BVMed explained that the Medical Devices Act prevailing in Germany since 1995 subjects all medical devices to very high legal requirements on safety and performance efficiency, a regulatory framework that has proven to be very reliable according to all parties, including the federal government and state authorities. The letter to the editor is signed by BVMed chairman of the board and Eucomed board member Dr. Meinrad Lugan and BVMed director general and board member Joachim M. Schmitt.

In the letter, BMed explains that before receiving marketing authorisation, within the scope of attaining the CE Marking, every medical device must undergo a separate risk analysis and a clinical evaluation. The law demands that every manufacturer submit a written document as valid proof of its product’s safety and medical-technological efficiency, tested and monitored by nationally accredited external auditing and certification bodies and authorities.

Furthermore, an additional clinical trial must be conducted for products with a higher risk potential. The clinical trial of medical devices is designed according to the clinical trials of pharmaceutical products, and is subject to the same strict prerequisites, such as an analysis procedure by an Ethics Commission and an approval procedure under the auspices of the German Federal Institute for Drugs and Medical Devices (BfArM). Since the term “medical devices” includes a very heterogeneous range of products, from simple tongue depressors and bandages to technical aids and implants and sophisticated large-scale equipment, the requirements for market entry rise with the level of risk potential of a product. BVMed stresses that patient safety and risk prevention have highest priority, BVMed.

According to the European Commission, the legal framework for medical devices has proven to work well and should not be changed to imitate drug approval laws. Medical devices and drugs must remain subject to different regulatory oversight. That also applies to the review process of the IQWiG, for instance for the methods of cost-benefit analysis.

Tags: BVMed, Medical Devices Act, Stern