Face-to-face meeting  /  June 20, 2022, 9:30 a.m.–4:00 p.m.

Regulatory Forum: Regulatory paths for personalized medical devices – challenges and implementation concepts

Interactive workshop at the interface between regulatory affairs and innovative biomedical engineering

Individualized medical device engineering, such as 3D-manufacturing, point-of-care manufacturing, AI-powered personalized software, but also companion diagnostics, is a key element of personalized medicine.

The existing regulatory requirements for mostly lower-risk medical devices regulated as “custom-made devices” in many cases are not applicable here. This is why regulatory solutions for the different types of personalized medical devices are being sought at the global level.

This interactive workshop, organized by the Fraunhofer High-Performance Center Medical and Pharmaceutical Engineering, provides an information exchange forum at the interface between the possibilities of biomedical engineering and regulatory requirements in the field of personalized medical devices. Based on the current understanding of the regulatory framework in this field, case studies will be used to present and discuss the challenges and possible solutions for placing personalized medical devices on the European market.

The workshop is intended mainly for scientists working in R&D departments as well as RA and quality managers from start-ups and small and medium-sized enterprises that have interfaces with personalized medical devices and are seeking regulatory access to the EU and global markets.

After the face-to-face workshop in German language in Hannover on June 20, 2022, a follow-up workshop in English language is planned to be held in fall 2022.