MedTech Europe and Mecomed have published considerations on the impact of the EU MDR and IVDR transition on international registrations in the Middle East and Africa, calling for a harmonised and risk-based approach to change management.

The preliminary draft 2027 Annual Union Work Programme for European standardisation includes a standardisation request for medical devices and IVDs under Regulations (EU) 2017/745 and 2017/746.

EMA has updated its Q&A on practical arrangements for the companion diagnostics consultation procedure by notified bodies, covering letters of intent, IRIS submissions, rapporteur appointment, pre-submission interactions, eSubmission and fees.

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.

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.

The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

Commission Implementing Decision (EU) 2024/2120 renews the designation of UDI issuing entities for medical devices and IVDs for a further five-year period, until 27 June 2029.

MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

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.

Swissmedic has updated its information sheet on performance studies of IVDs, covering study categories, approval processes, ISO 20916, reporting duties, safety measures and sponsor obligations.

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.

Swissmedic has updated its information sheet on IVD performance studies, covering approval procedures, reporting duties, ISO 20916, category C studies and Swissmedic surveillance.

The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.

Swissmedic has updated its swissdamed User Guide for the UDI Devices Module, including guidance on UDI registration, market status, M2M, Master UDI-DI and legacy devices.

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