On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical devices ‘ compliance in the European Union:
- New: Position Paper on IVDR Certification Process provides guidelines to documents’ submission
- Update: Position Paper on the submission of technical documentation according to Annex II and III of MDR is a Best Practice Guidance of manufacturing approaching a notified body (Version 3)
- Update: Position Paper on European Artificial Intelligence Regulation (Version 2)
Guidelines on IVDR certification process
Team-NB Position Paper “IVDR Certification Process (including Pre-application, Application and Post Application phases)” offers detailed guidance for manufacturers seeking certification of in vitro diagnostic medical devices under the EU In Vitro Diagnostic Regulation (IVDR). Particularly, the document aims to harmonise the certification process across Notified Bodies, thereby reducing incomplete submissions and expediting assessments. In addition, the document includes an appendix listing the specific data and documents that manufacturers must submit at various stages of the certification process. Nonetheless, every Notified Body can request additional information to satisfy their specific operational processes.
Best Practice Guidance for technical documentation submission under MDR
Similar to the guidelines on IVDs, Team-NB “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745” is an updated guidance for manufacturers of medical devices approaching Notified Bodies for the MDR certification. With its third revision, the guidance focuses on the structure and content of technical documentation as specified in Annexes II and III of the MDR. Specifically, it addresses common difficulties and offers practical advice to ensure submissions meet regulatory requirements.
Position Paper on Artificial Intelligence Notified Bodies
Team-NB Position Paper “European Artificial Intelligence Act” provides insights into the implementation of the EU Artificial Intelligence Act (AI Act) concerning medical devices and in vitro diagnostic medical devices. The updated document (second revision) emphasises the need for a coordinated approach among EU member states to designate and oversee Notified Bodies for AI systems. Among other challenges, the position paper highlights concerns about potential delays in national implementations that could lead to a shortage of designated Notified Bodies when the high-risk provisions of the AI Act become applicable on 2 August 2027. Thus, a swift designation of Notified Bodies is pivotal to the implementation of the AI Act.
Do you have questions on compliance of medical devices and IVDs? Are you looking to approach a notified body? Contact us here or at mdlaw@obelis.net.
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