MDCG 2025-6 — FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) — (June 2025)

MDCG 2025-4 — Guidance on the safe making available of medical device software (MDSW) apps on online platforms — (June 2025)

MDCG 2019-11 rev.1 — Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 — (June 2025)

MDCG 2024-7 rev.1 — Preliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents) — (January 2025)

MDCG 2024-8 rev.1 — Preliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents) — (January 2025)

MDCG 2021-16 rev.1 — Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation ( IVDR ) Annex to Application Form & PAR Template IVDR (List of documents) — (January 2025)

MDCG 2021-15 rev.1 — Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation ( MDR ) Annex to Application Form & PAR Template MDR (List of documents) — (January 2025)

MDCG 2025-6 / AIB 2025-1 provides essential guidance on the concurrent application of EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the EU Artificial Intelligence Act (AIA, Regulation 2024/1689) to AI-based medical devices (MDAI). The document clarifies the regulatory pathway for manufacturers placing AI-enabled Software as a Medical Device (SaMD) on the EU market. The guidance specifies conformity assessment procedure selection, integration of quality management system requirements, and the treatment of overlapping clinical evaluation and AIA-mandated documentation obligations. Manufacturers should use this document to identify applicable requirements under both MDR/IVDR and AIA frameworks, streamline compliance activities, and establish unified governance structures. The document represents the coordinated position of the Medical Device Coordination Group and the AI Board, establishing a harmonized implementation framework for AI-based medical devices within the European regulatory environment.

MDCG 2024-16 — Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices — (December 2024)

MDCG 2024-15 — Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED — (November 2024)