- 30.04.2013 Post Market Surveillance: Sorting out the Sheep From the Goats
According to attorney at law Dr. Volker Lücker, a well-functioning market surveillance system by state authorities was essential for people’s confidence in the safety of medical devices. In this field, improvements were about to be introduced in Germany through a uniform market surveillance based on quality assurance, to identify and sort out the sheep from the goats at an earlier stage, said the legal expert on the occasion of the BVMed conference “Clinical Evaluation and Market Surveillance of Medical Devices“ in Bonn.
PressemeldungBerlin/Germany, 30.04.2013
Clear differentiation to the tasks of the Notified Bodies
Lücker welcomed the new implementing rule for the regulatory authorities requiring the application of quality management procedures to medical device surveillance. Medical device manufacturers had to comply with these requirements since 1993. A well-functioning market surveillance was essential for confidence in the safety of medical devices. It was the responsibility of the Notified Bodies to ensure that the documentation was correct while market surveillance had to verify that products actually were as they should be. Inspections, discussions with staff and drawing of samples could contribute to counteracting criminal practices more effectively in future. “We have to sort the sheep from the goats at an earlier stage to strengthen the confidence in the medical devices system,“ Lücker said. However, this had to be clearly differentiated from the tasks of the Notified Bodies to avoid unnecessary dual examinations and, hence, time delays and additional financial burden for manufacturers. Lücker postulates: “We need a graded surveillance process which is oriented by the procedures of the Notified Bodies.“
Clinical trials: Proven practice
The obligation to obtain authorization for clinical trials by the Federal Institute for Drugs and Medical Devices (BfArM) and by the Ethics Committees has generally proven effective. About 70 percent of the requests for approval for clinical trials were approved by BfArM, Dr. Wolfgang Lauer, head of the BfArM Medical Devices Division, said. Dr. Christian von Dewitz of the Ethics Committee in Berlin underlined that the favorable vote by the Ethics Committee had the same legal value as for pharmaceuticals.
High quality of CE marking
BVMed Director General and Member of the Board, Joachim M. Schmitt, explained that, before receiving the CE marking, a medical device manufacturer was required to prove the safety and performance of the devices to state-appointed and state-supervised approval bodies. This included risk analysis, clinical evaluation and a quality management system. “Hence, the proof of performance and effectiveness for medical devices by far exceeds the requirements for the CE marking of other products such as toys,“ Schmitt said.
