Market withdrawal of medical devices with higher risk class is disproportionately high

At the end of November, the dossier "Implant Files" reported inferior medical devices endangering patients or even leading to their death. Federal Health Minister Jens Spahn then announced the establishment of a central register for implants.

Unfortunately, the recent response to a parliamentary inquiry on market access and monitoring of medical devices does not provide more clarity on the medical device market. For example, due to the lack of available data, there are no meaningful figures for the number of medical devices on the market. However, the market withdrawal for medical devices with higher class is disproportionately high: In the period from 2010 to November 2018, the CE-certification was withdrawn for 218 class III products. This corresponds to a share of 20% in this product class, but the overall market share of these medical devices is only 1%.

Nevertheless, the situation is said to have improved compared to the past, said a spokesman from the Central Office of the Federal States for Health Protection of Medicines and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln undMedizinprodukten, ZLG). The quality of medical devices was discussed last week by the Health Committee of the German Bundestag. It remains to be seen what consequences the policy will draw from the present reports.

As experts for market access of medical devices, SKC consulting follows the current developments of the market. You will find detailed explanations in our case studies for medical- and biotechnology.

BY Heike Kielhorn-Schönermark, MBA, managing director and Karolin Priese, MBA