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. When preparing a GSPR compliance matrix, CER, or PMS plan, using the relevant MDCG guidance as the framework is appropriate and expected by NBs assessing Swiss market access applications.
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.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.