Swissmedic Recognised Standards List
Overview
Switzerland adopts the same harmonised standards as the EU for medical devices. Standards published in the Official Journal of the European Union as harmonised under EU MDR or IVDR are also recognised in Switzerland under MedDO/IVDO. Using a recognised harmonised standard provides a presumption of conformity with the GSPRs it covers.
How Swiss Harmonised Standards Work
The Swiss approach mirrors the EU approach:
- A standard is harmonised when published in the EU Official Journal under MDR or IVDR
- Swissmedic recognises the same standards — no separate Swiss publication is required
- Using the harmonised standard creates a presumption of conformity with the corresponding GSPR provisions
- Departure from a harmonised standard is permitted but requires alternative justification of equivalent safety and performance
Key Harmonised Standards by Topic
| Standard | Scope | Key GSPR Application |
|---|---|---|
| ISO 14971:2019 | Risk management | Annex I §§ 1–9 |
| ISO 13485:2016 | QMS for medical devices | General QMS requirement |
| IEC 62304:2006+A1:2015 | Software lifecycle | Annex I § 17 |
| IEC 62366-1:2015+A1:2020 | Usability engineering | Annex I § 5 |
| ISO 10993-1:2018 | Biological evaluation — risk assessment | Annex I § 10 |
| ISO 10993-5:2009 | Cytotoxicity | Annex I § 10 |
| EN ISO 11135:2014 | Sterilisation by EO | Annex I § 11 |
| EN ISO 11607-1/2:2019 | Packaging for terminally sterilised devices | Annex I § 11 |
| ISO 11137 series | Sterilisation by radiation | Annex I § 11 |
| EN ISO 17665-1:2006 | Sterilisation by moist heat | Annex I § 11 |
| IEC 60601-1:2005+A1:2012 | Electrical safety for active devices | Annex I §§ 12–14 |
| IEC 60601-1-2:2014+A1:2020 | EMC for active devices | Annex I § 13 |
| IEC 60601-1-6:2010+A1:2013+A2:2020 | Usability for active devices | Annex I § 5 |
| IEC 81001-5-1:2021 | Software cybersecurity | Annex I § 17.2 |
| ISO 15223-1:2021 | Symbols for medical devices | Annex I § 23 |
| ISO 17664:2021 | Reprocessing of health-care devices | Annex I § 23.4 |
| EN ISO 15747:2018 | Plastics containers for intravenous injections | Annex I § 10 |
How to Verify Current Recognition Status
The definitive, current list of harmonised standards is published in the EU Official Journal and is mirrored by Swissmedic:
- EU Official Journal — harmonised standards under MDR
- Swissmedic — harmonised standards
- Always verify the current version of a standard is referenced — using an outdated standard version may not provide presumption of conformity
Using Non-Harmonised Standards
Non-harmonised standards (e.g. ASTM standards, some ISO standards not yet harmonised under MDR/IVDR) may still be used as technical evidence. However, they do not carry the presumption of conformity and the manufacturer must explicitly justify why the standard provides an equivalent or higher level of safety than the GSPR requires.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.