Switzerland Medical Device Regulations
Medical devices regulating body: Swiss Agency for Therapeutic Product (Swissmedic)
Current Switzerland Market Situation:
- As the Institutional Agreement (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA)
- No barrier free access to the EU internal market.
- Swiss has been downgraded to the third country.
- Swiss manufactures has stricter requirements when exporting their medical devices to the EU.
- The center of the responsibility defined by law.
- Prove and document conformity of the products, including correct classification.
- Introduction and maintenance of a QMS system.
- AR is dependent on the manufacturer to fulfil his obligations.
- Manufacturer must be contractually obliged to guarantee the authorized representative full compliance of his legal duties.
- Legal duties include- CE mark, UDI, IFU, Translation into Swiss languages.
- Manufacturer must supply the AR with extensive documentation.
- Manufacturer is obliged to retain the technical documentation, declaration, certificate of conformity, including amendments and supplements for 10-15 yrs.
- AR to keep commercial records for 10 yrs.
Manufacturers outside Swiss:
- After 26 May 2021 , foreign manufacturers must appoint a Swiss authorised representative in order to sell their devices in the market.
- Agreement between the manufacturer and the AR is needed.
- Who is a Swiss AR
– Proxy to the foreign manufacturer
– Responsible for product safety
– Liable for product defects
– Contact person for Swiss authorities
– Can be legal entity or as a natural person
– Must have access to PRRC
Swiss Authorised Representative
- A Swiss authorized representative (Swiss AR) is a legal person appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market.
- A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory.
- Manufacturers can appoint only a single Authorised representative in Switzerland.
- According to the Swiss ordinance on medical devices, the authorized representative is responsible for any product defects. AR is jointly and severely liable for product defects with manufacturer.
Update for Manufacturers in EU & Swiss:
- Registration and notification obligations do not run via EUDAMED, but via Swissmedic.
- Economic operators who have already placed products on the market before 26 May 2021 in accordance with the MDR and IVDR must complete their registration by 26 November 2021.
- Access to the technical documentation may be provided either by keeping a copy available at the authorised representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days.
- The validated Summary of Safety and Clinical Performance (SSCP) is not uploaded by the Notified Body in EUDAMED, but published by the manufacturer, for example on its website.
EU Manufacturer Exporting to Swiss:
- Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements.
- Timeline to appoint Swiss AR:
Swiss Manufacturer Exporting to EU:
- For MDR regulated devices & class I devices: Follow third country requirements from 26th May 2021.
- For MDD certified devices: No third country requirements, they will be regulated under MRA, free access to the EU market as before until May 2024.
How we assist you with this process?
- Act as your Swiss Authorised Representative
- MedDO compliance
- EUDAMED registration
- Product information translations in German, French, Italian language
- EU MDR, IVDR gap analysis
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory Affairs solutions
Contact us for free consultation: [email protected]