Team-NB, TÜV Verband and TIC Council highlight the importance of maintaining strict, risk-based oversight in the MDR/IVDR revision to protect patient safety.

A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.

The EU Commission 20th Notified Body Survey shows a slight decline in MDR applications and continued growth in IVDR applications, highlighting ongoing certification pressures under the MDR and IVDR.

Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.

Team-NB has highlighted the need for broader notified body access to EUDAMED vigilance, clinical investigation and performance study data to support proportionate risk-adaptive surveillance under the MDR and IVDR.

Team-NB has presented a proposal for risk-adaptive notified body surveillance under the MDR and IVDR, aiming to reduce unnecessary burden while maintaining patient safety and effective oversight.

Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.

European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.

Regulation (EU) 2017/745 sets out the European regulatory framework for medical devices, covering market access, economic operators, clinical evaluation, vigilance, PMS, UDI and notified bodies.

The European Commission has published Member State summaries of the 2025 annual reports on monitoring and on-site activities regarding notified bodies under the MDR and IVDR.

The European Commission has commissioned a study to monitor the availability of medical devices on the EU market, including dashboard data and surveys of notified bodies, economic operators and health service providers.

NBCG-MED has published operational elements for the application of hybrid audits to QMS assessments under the MDR and IVDR, including on-site requirements, ICT use and audit planning.

The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.

The European Commission has published the 20th Notified Body survey results under the MDR and IVDR, with data status 28 February 2026.

The European Commission has published the third EO survey results on the availability of medical devices and IVDs on the EU market, with data status 31 October 2025.

Team-NB has published a proposal for a risk-adaptive surveillance system under the MDR, covering surveillance audits, unannounced audits, technical documentation sampling and PSUR updates.

Team-NB has published a proposal for a risk-adaptive surveillance system under the IVDR, covering surveillance audits, unannounced audits and technical documentation sampling.

Team-NB has published a position paper proposing measures to support micro and small medical device manufacturers under the MDR and IVDR, focusing on regulatory efficiency, structured dialogue, risk-based oversight and regulatory capability.

The MDCG has published MDCG 2026-4, providing clarification on the management of Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents in EUDAMED following the mandatory use of the platform’s first modules.

MedTech Europe has published its position on the European Commission’s proposal to simplify the MDR and IVDR, supporting a more proportionate and risk-based approach to oversight, surveillance and assessment activities throughout the lifecycle of medical devices.