Switzerland Medical Device Registration, Swiss authorised representative (CH-REP)

Switzerland Medical Device Registration Overview

Switzerland is a prominent leader in medical technology innovations. After, exiting from the EU’s single market, it developed its regulatory framework – Medical Device Ordinance (MedDo) and In Vitro Diagnostic Devices Ordinance (IVDO). This ordinance was outlined in line with the European Directives, but later it was revised and aligned with the European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746. The MedDO came into effect on May 26, 2021, while the IVDO came into effect on May 26, 2022. Foreign medical device manufacturers must appoint a Swiss authorised representative (CH-REP) to help them comply with Switzerland medical device registration guidelines.

Regulatory Authority: Swiss Agency for Therapeutic Product (Swissmedic)
Regulation: Medical Device Ordinance (MedDO)and In Vitro Diagnostic Device Ordinance (IvDO)
Regulatory Pathway: Notification
Authorized Representative (AR): Swiss Authorized Representative (CH-REP)
QMS Requirement: ISO 13485:2016
Assessment of Technical Data: Designated Body
Validity of License: Five (05) Years
Labeling Requirements: Regulation (EC) No 1272/2008; Labeling Must Be Provided in German, French and Italian
Submission Format: Online
Language: German, French and Italian

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 Device	What 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 III	Via notification form and product list template	Swiss manufacturers
Custom made devices	Via notification form	Swiss manufacturers, Ars, importers / distributors
Systems and procedure packs	Via notification form	Swiss based assemblers
MD – Devitalized human tissue	Via notification form	AR, legal manufacturer
Device products	Via notification form	Legal manufacturers, Ars, importers / distributors
Repacked or relabeled medical devices	Via notification form and product list template	Swiss importers / distributors
Medical devices manufactured and used in health institutions	Via notification form	Swiss health institutions

Swissmedic Notification Requirements for IVDs

Type of Device	What has to be done?	Responsible Entity
IVD	Via notification form	Authorized representatives or Swiss manufacturers
Self-testing IVDs, other IVDs	Via notification form	Individual
IVD manufactured in-house by the producing or partner company	Via notification form	Swiss manufacturers