On February the 9th, VitroScreen organized a scientific seminar to open a discussion on the qualification and classification issues for substance based medical devices (SBMDs) as introduced by the Medical Device Regulation EU 2017/475 (MDR) and faced by the MDCG 2022-5 guidance on borderline products.

The discussion with stakeholders of the Medical Device industry present to the seminar (Health Authorities, Notified Bodies, Academia, Industry and ISO representative) allowed to analyze the available state of the art approaches through which provide scientific evidence on the principal mode of action of SBMDs and respond to MDR requirements.

During the discussion it was emphasized that making scientific data available to the European authorities is crucial to base regulatory decisions on sound scientific data and foster innovation in the field.

The seminar was attended by 87 participants from Italy (in presence) and from Spain, Switzerland, UK, France, Lithuania and the Netherlands (via web). Peter Nählstedt, Senzagen CEO, was also present and thanked the participants for the relevant discussion on the topic.