Commission Draft on MDR/IVDR: TÜV Association and IG-NB Highlight Practical Concerns

The planned EU Implementing Regulation on uniform requirements for Notified Bodies under MDR and IVDR contains important elements from the perspective of TÜV Association and IG-NB — but also includes requirements that are not feasible in practice. In their joint statement, the organisations advocate for more realistic timelines, flexible procedures and reduced bureaucracy — particularly in the interest of small and medium-sized enterprises.

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Blick in einen Kellerraum, in dem sich die Last der Bürokratie in Form voller Bücherregale und überquellender Ordner zeigt

26. January 2026 Mark Küller© Onur Burak Akin via Unsplash

In a joint position, TÜV Association and IG-NB welcome the European Commission’s objective to establish harmonised requirements for Notified Bodies under MDR and IVDR through a new Implementing Regulation. However, they raise concerns about several aspects of the proposal that appear impractical — especially overly tight deadlines, unnecessary administrative burdens, and a lack of procedural flexibility. These issues could lead to higher costs, delays, and risks to patient safety, particularly for SMEs. The organisations propose more realistic timelines, voluntary SME status declarations, and flexible approaches to maintain a high-quality and independent conformity assessment system.