Stricter regulatory framework – act now!

21.11.2018 Stricter regulatory framework – act now!

Codex4SMEs – international information event about the EU’s IVDR

BioRegio STERN Management GmbH held an initial double session focusing on the EU’s Codex4SMEs project to provide participants from all over Europe with information about the new In Vitro Diagnostic Regulation (IVDR). This regulation became effective in 2017 and is forcing manufacturers to make numerous changes to the licensing procedure.

The EU’s new In Vitro Diagnostic Regulation (IVDR) is intended to improve patient safety. Following a transitional period, it will apply to all manufacturers of in vitro products with effect from May 2022. During the first part of the symposium organised by BioRegio STERN Management GmbH as part of the EU’s Codex4SMEs project, Dr. Andreas Stange from inspection and certification company TÜV Süd told his audience about the IVDR’s new requirements relating to product safety, performance and quality, which are based on classification, documentation and quality management. TÜV Süd is one of the few institutions in Europe that has already applied to be a notified body and offers the necessary expertise for licensing medical products. In vitro diagnostics (IVD) are medical products for testing urine, blood and tissue samples outside the body in a laboratory. Regulations for all medical devices controlled by state-appointed/supervised inspection bodies are becoming more stringent across the board.

After Dr. Heidrun Sturm, owner of Healthcare-Strategies HS2 and a scientist at the University Hospital Tübingen’s Institute for General Medicine and Interprofessional Care, had provided an overview of the German healthcare system and market, the second part of the symposium offered delegates the opportunity to participate in European “matchmaking”. Representatives from companies in France, the Netherlands and the United Kingdom who had gathered in Stuttgart not only discussed the new European licensing regulation. They also used the event for targeted international networking and to initiate cooperation arrangements.

“We’re offering this event at an early stage to give businesses time to adapt to the new requirements and enter into dialogue with other companies at a European level,” explains project manager Dr. Margot Jehle from BioRegio STERN Management GmbH. “The IVDR is making the existing regulations far tougher, which means small, innovative companies in particular need to respond quickly if they are to obtain and safeguard access to the market,” she adds. BioRegio STERN Management GmbH is the German lead partner for the Interreg project Codex4SMEs. Events such as the IVDR symposium encourage the creation of a transnational network to accelerate the development of companion diagnostics by small and medium-sized enterprises.


project leader
Dr. Margot Jehle
E jehle [at] bioregio-stern.de
T +49-711-870354-29