Manufacturers, suppliers, vendors and importers have half a year before the Medical Device Regulation (MDR) takes effect. The departmental bill for the German Medical Devices Adjustment Act already exists. The first notified bodies are already accredited under the MDR, while others are not even seeking accreditation. Many questions remain unanswered. Calls for an extension of the adjustment period are growing louder and warnings about supply shortages as a consequence of the MDR’s (excessive) regulations are being taken more and more seriously. Manufacturers need to comply with the new regulatory requirements so that they will be able to continue marketing their products. Cooperation with notified bodies is absolutely necessary, but this cooperation is currently falling apart in practice due to the absence of notified bodies and/or their unwillingness to act, creating massive hindrances for manufacturers. It is also necessary to ensure that “new” technologies like 3D printing, as well as the digitization and networking of formerly “analog” medical devices, medical apps and AI, are in compliance with the GDPR and MDR as early as the development phase so as to minimize resulting liability risks.
- What would a sensible last-minute MDR strategy look like?
- How can notified bodies be motivated to cooperate?
- What impact will the Medical Devices Adjustment Act have?
- Which liability risks will manufacturers and economic operators face in the future under the MDR?
- Who will be liable for patient injuries caused by defective software or AI?
- What rules does the GDPR establish for health data?
We would like to use our business brunch on 22 November 2019 to discuss these questions with you and we look forward to a lively exchange.
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