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.

EMA has updated the list of CECP opinions issued by Expert Panels for medical devices undergoing conformity assessment, supporting transparency in the Clinical Evaluation Consultation Procedure.

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.

The European Commission is considering allowing electronic instructions for use for all professional-use medical devices and has launched a survey for healthcare professionals and healthcare institutions in the EU.

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.

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

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.

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.

The European Commission expert panel has issued a CECP scientific opinion on a Class III implantable dual-chamber leadless pacemaker, highlighting clinical evidence, benefit-risk assessment and PMS considerations.

Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.

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 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.

The CD-P-TO has published a position paper on the MDR and its implications for the substances of human origin sector, focusing on Article 5(5), RUO products and CE-marked devices used beyond their intended purpose.