Switzerland Medical Device Registration

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Medical Device Classification

The medical device classification in Switzerland is similar to the EU MDR’s classification system. The devices are classified into four (04) classes – Class I, IIa, IIb and III. The Medical Device Coordination Group (MDCG) guidelines for medical devices and in-vitro devices classification rules are also applicable under the Ordinance.

Freyr provides comprehensive services for Medical Device Classification for Switzerland as well.

Switzerland Authorised Representative (Swiss AR/CH-Rep) Services

Foreign medical devices or IVDs must appoint a Swiss Authorized Representative before placing the products in Switzerland. The manufacturer and the representative must have an agreement in place. The Swiss Authorized Representative for a medical device will act on behalf of the Swiss manufacturer and as the key contact person for Swissmedic and associated Authorities. The Swiss Representative shall be a natural person or can be a legal entity. The Swiss Authorized Representative (AR) is responsible for product safety and is liable for product defects. The Swiss AR must appoint a Person Responsible for Regulatory Compliance (PRRC).

Medical Device Registration

Similar to EU MDR and EU IVDR, under Swiss Ordinance the medical device is required to undergo conformity assessment with the notified body and obtain certification.

Freyr supports the manufacturers with medical registration services. In addition, it also supports end-to-end regulatory services.  

Swissmedic Notification Requirements for Medical Devices

Type of DeviceWhat has to be done?Responsible Entity
Class I devices according to the EU MDR 2017/745 and Directive 93/42/EEC are those that fall under the Classes I, IIa, Iib or IIIVia notification form and product list templateSwiss manufacturers
Custom made devicesVia notification formSwiss manufacturers, Ars, importers / distributors
Systems and procedure packsVia notification formSwiss based assemblers
MD – Devitalized human tissueVia notification formAR, legal manufacturer
Device productsVia notification formLegal manufacturers, Ars, importers / distributors
Repacked or relabeled medical devicesVia notification form and product list templateSwiss importers / distributors
Medical devices manufactured and used in health institutionsVia notification formSwiss health institutions

Swissmedic Notification Requirements for IVDs

Type of DeviceWhat has to be done?Responsible Entity
IVDVia notification formAuthorized representatives or Swiss manufacturers
Self-testing IVDs, other IVDsVia notification formIndividual
IVD manufactured in-house by the producing or partner companyVia notification formSwiss manufacturers

 

Switzerland Medical Device

Freyr Expertise

  • Swiss Authorized Representative Services
  • Medical Device Ordinance (MedDO) Compliance
  • In Vitro Diagnostic Device Ordinance (IvDO) Compliance
  • Swissmedic Device and IVD Notifications
  • Swissmedic Registrations
  • Device Information and Label Translations
  • Gap Analysis – MedDO and IvDO

Our Location in Switzerland

Bahnhofplatz,
6300 Zug,
Switzerland