MDCG Guidance — Applicability in Switzerland
Overview
The Medical Device Coordination Group (MDCG) publishes guidance on EU MDR/IVDR interpretation. Because MedDO and IVDO mirror EU MDR/IVDR, MDCG guidance documents generally apply in Switzerland. Swissmedic has confirmed this position and EU-designated NBs apply MDCG guidance as a matter of course.
Using MDCG Guidance in Swiss Submissions
MDCG guidance may be cited in technical documentation and conformity assessment submissions as the primary framework for interpretation of MedDO/IVDO requirements. When preparing a GSPR compliance matrix, Clinical Evaluation Report (CER), Post-Market Surveillance (PMS) plan, or Post-Market Surveillance Report (PSUR), using the relevant MDCG guidance as the reference framework is appropriate and expected by EU-designated Notified Bodies (NBs) assessing Swiss market access applications. Manufacturers are encouraged to reference specific MDCG document sections when documenting compliance with GSPR provisions.
Key MDCG Documents Applicable in Switzerland
| MDCG Document | Topic |
|---|---|
| MDCG 2019-9 | Summary of Safety and Clinical Performance (SSCP) |
| MDCG 2019-11 | Software qualification and classification (SaMD) |
| MDCG 2019-16 | Cybersecurity for medical devices |
| MDCG 2020-1 | AI and ML in medical devices |
| MDCG 2020-5 | Clinical evaluation — equivalence |
| MDCG 2020-6 | Clinical evidence for legacy devices |
| MDCG 2020-7 | PMCF plan template |
| MDCG 2020-8 | PMCF evaluation report template |
| MDCG 2020-13 | PMCF overview report template |
| MDCG 2020-16 | IVD classification |
| MDCG 2021-6 | Q&A on vigilance terms and concepts |
| MDCG 2021-17 | UDI guidance |
| MDCG 2021-24 | Classification of medical devices |
| MDCG 2022-2 | Clinical evidence for IVDs |
| MDCG 2022-5 | Borderline between medical devices and other products |
| MDCG 2022-21 | PMS plan/report and PSUR templates |
For the current complete list: European Commission MDCG guidance page.