New requirements for Switzerland

New differing requirements now apply to EU and Swiss medical device manufacturers.

As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as a third country since May 26, 2021. Therefore, new strict rules are consequently being implemented and have to be observed by both European and Swiss manufacturers. In this article we sum up the main changes.

Authorised Representative:

In the article MDR entry into force: situation in Switzerland, we explained the consequences of a non-signing of the MRA for Swiss Manufacturers, namely the appointment of:

• • an EU Authorised Representative (EAR) to export medical devices to the EU.
  • a Swiss Authorised Representative (CH-REP) to import medical devices into Switzerland.

Here (Art. 104a MedDO) you can find the transition periods that apply to EU manufacturers (not to importers!) to appoint authorised representative, and here an information sheet from Swissmedic on CH-REP. 

Swiss Single Registration Number (CHRN):

• Like the Single Registration Number (SRN) for EUDAMED, the CHRN is used to identify actors.
• Manufacturers, authorised representatives and importers based in Switzerland must register with Swissmedic and apply for a CHRN within 3 months of placing their first product on the Swiss market.
• If devices were already placed on the market before May 26, 2021, then the economic operators must register by November 26, 2021.
  • To obtain a CHRN, see this Swissmedic page.
• Distributors do not need a CHRN.

Swiss actors:

• Swiss manufacturers must still register devices and economic operators in EUDAMED to place devices on the EU market, as well as conducting incidents reports, post-market surveillance, and conformity assessments.
• “Importers” are natural or legal persons established in Switzerland who place products from the EU on the Swiss market. 
• Swiss distributors can act as authorized representatives, however their designation as such is not automatic. 
• Certificates issued before May 26, 2021 in Switzerland are no longer recognized in the EU. Thus, manufacturers must conduct an EU MDR conformity assessment.

EU actors:

• It remains unclear whether EU manufacturers AND/OR their Swiss authorized representatives and Swiss importers will have to register with Swissmedic within 3 months of the initial placing on the market.
• MDR certificates are recognized.
• The old legal certificates according to MDD are also recognized (Art.100 mepV).
• No need for additional labelling: Switzerland recognizes CE marking
• No need for additional conformity assessments: Switzerland recognizes certificates issued by EU notified bodies.
• Reports (serious incidents and field safety corrective actions) must be sent to Swissmedic by the Swiss authorised representative.