Virtual Lunch Medical Devices Show us your files - official inspections of medical device and IVD manufacturers

In Germany, the surveillance authorities of the federal states play an important role in the market surveillance of medical devices and IVDs.

As part of this task, they can carry out inspections of manufacturers and check compliance with legal requirements on site. If non-compliance is found, the authorities can order the manufacturer to take official measures. The measures range from the obligation to improve SOPs to a ban on placing the products on the market. In contrast to audits by a Notified Body, inspections are also carried out on manufacturers of Class I or A devices.

Dr. Christoph Renz (VOELKER & Partner) and Christoph Kiesselbach (Schrack & Partner) explain what manufacturers can expect during such an inspection, how the authorities proceed, what the consequences are and how they can prepare themselves. In doing so, they will address the legal basis and the authorities' templates. Practical examples will be used to illustrate best practice in dealing with the authorities and legal protection against official measures will be explained.

No registration necessary, direct participation via the link.