Latest industry news and developments
The European Commission has published updated templates for MIR and FSCA forms, standardizing how medical device incidents are reported. These documents align with Eudamed requirements and evolving expectations from regulators and manufacturers, enhancing transparency and interoperability across the EU.
Switzerland has adopted regulatory changes enabling temporary authorization for high-risk medical devices even without MDR or Swiss approval. The law allows imports from trusted markets (EU, USA, Canada) to address critical supply gaps.
The updated Team-NB guidance on technical documentation provides manufacturers with a comprehensive framework to build MDR-compliant technical files. While non-binding, the document is widely regarded as a reference standard by many notified bodies. Version 3 incorporates updates based on real-world assessments and lessons learned across the sector.
Another inspiring weekend behind us! Our experts from Pure Clinical and MDR Regulator once again led engaging sessions as part of the postgraduate program “Certification and Market Introduction of Medical Devices” at Bialystok University of Technology.
The “IVDR Certification Process – Consensus Document” was developed by Team-NB to provide a unified set of good practices for conformity assessment under IVDR. It reflects not only the regulatory framework but also operational insights gained from notified body assessments during the first years of IVDR implementation. While not legally binding, the document serves as a valuable reference for manufacturers preparing for certification.
The Medical Device Coordination Group (MDCG) has published an updated version of its guidance MDCG 2020-16 rev.4, concerning the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The revision aims to clarify classification rules in light of emerging technologies and the evolving diagnostic landscape. It includes new examples, refined terminology, and practical advice to support both manufacturers and notified bodies in assigning the appropriate risk class to IVDs.
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) provide the possibility to issue certificates with conditions, limitations, or restrictions. This regulatory flexibility can facilitate market access for innovative and breakthrough medical technologies that may not yet have a complete clinical evidence base. Team-NB, the European Association of Notified Bodies, has published a position paper promoting the wider use of this tool.
Last week, for the second consecutive year, we participated in the MedTech Summit in Budapest – one of the key industry events dedicated to medical device regulations. Our CEO, Katarzyna Wesołowska, shared her expert insights during the discussion panel “Consultants' Experiences in Transitioning from MDR to IVDR.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the registration requirements for Class I medical devices and those with expired CE certificates. The new regulations aim to improve oversight of medical device safety and compliance with UK regulations.
