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IMDRF Guidance Adoption Status

Overview​

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulatory authorities from around the world that works to harmonise medical device regulatory approaches internationally. Switzerland participates in IMDRF activities through Swissmedic, and many IMDRF guidance documents are applicable in Switzerland as they inform the development of EU MDR/IVDR and therefore MedDO/IVDO.

Switzerland's Role in IMDRF​

Swissmedic participates in IMDRF as an affiliate member, allowing it to contribute to IMDRF working group discussions and to align Swiss regulatory guidance with developing international standards. Swiss regulatory requirements for SaMD, UDI, clinical evidence, and cybersecurity closely reflect IMDRF guidance frameworks.

Key IMDRF Documents Applicable in Switzerland​

Software as a Medical Device (SaMD)​

  • IMDRF/SaMD WG/N10, N12, N23, N41 — SaMD framework (definition, risk framework, clinical evaluation, QMS) — foundational documents that informed both MDCG 2019-11 and Swissmedic's approach to SaMD qualification and classification in Switzerland

Unique Device Identification (UDI)​

  • IMDRF/UDI WG/N7, N48 — UDI system framework and implementation guidance — directly reflected in MedDO/IVDO UDI requirements and DAPI UDI registration

Clinical Evidence​

  • IMDRF/MDCE WG/N55, N56, N57 — Clinical evaluation series (framework, equivalence, literature review) — used alongside MDCG 2020-5/6 in Switzerland

Cybersecurity​

  • IMDRF/CYBER WG/N60, N70 — Cybersecurity principles (legacy and new devices; vulnerability and exploit reporting) — foundational for IEC 81001-5-1 and MDCG 2019-16 which apply in Switzerland

Auditing​

  • IMDRF/MDSAP WG — Medical Device Single Audit Program (MDSAP) — MDSAP audits are not directly recognised by Swissmedic or EU NBs for MedDO conformity assessment purposes, but may be accepted as supporting evidence for QMS assessments

Adverse Event Terminology​

  • IMDRF/AE WG/N43 — Adverse event terminology — influences Swissmedic vigilance guidance definitions

How to Use IMDRF Guidance in Swiss Submissions​

IMDRF guidance can be cited in technical documentation as supporting evidence for design choices and risk management approaches. When a corresponding MDCG document exists that is directly applicable in Switzerland (e.g. MDCG 2019-11 for SaMD, informed by IMDRF SaMD framework), prefer citing the MDCG document as the primary reference.

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.