6 March 2023
Due to the absence of a mutual recognition agreement with Europe, there are several regulatory requirements for the marketing of Medical Devices and In Vitro Diagnostic Medical Devices in Switzerland.
Today, the market access regulatory system presents numerous pre- and post-market requirements that Thema is able to address in a clear, professional and concrete manner.
With its services, Thema can cope with everything that is necessary to enable its clients to place their devices in Switzerland.
The role of the Authorised Representative in Switzerland (CH REP)
Manufacturers located outside of Switzerland must appoint an Authorised Representative (AR or CH REP) located in Switzerland, with responsibilities similar to those of the European Representative, as defined by MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Infact, the Swiss device regulations (MedDO/IvDO) had been amended to meet the MDR/IVDR requirements according to Articles 11 and 12.
What are the obligations of CH REP?
- Draw up and sign a Contract of mandate (QTA) for each manufacturer they represent;
- Appoint a Person Responsible for Regulatory Compliance (PRRC);
- Ensure the manufacturer has carried out the appropriate Conformity Assessment process and drawn up the relevant Technical Documentation;
- Keep the Technical Documentation available to Swissmedic in case of request;
- Be the point of contact between the Manufacturer and Swissmedic;
- Carry out post-market communications including those related to vigilance, including notifying manufacturers of any complaints or events.
When is the deadline to appoint a CH REP?
If the device has already been marketed in Switzerland, the following transition periods have been established for the appointment of the Authorised Representative:
- Class IIb implantable, Class III and AIMD – by 31 December 2021
- Class IIb non-implantable, Class IIa – by 31 March 2022
- Class I, systems and procedure packs – by 31 July 2022
- Class D IVD- by 31 December 2022
- Class C, B IVD- by 31 March 2023
- Class A IVD- by 31 July 2023
The requirement to appoint a CH REP applies to both IVDD and IVDR CE-marked devices. If the device is IVDD CE-marked, the transition period is based on the device’s eventual new classification under the IVDR.
To this end, please note that the MDCG guideline 2020-16 Rev.2 has been updated- Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – February 2023- to which it is necessary to refer for the identification of the IVDR class and thus also for the purposes of the appointment of the CH REP.
In other words, if the Device is placed on Swiss territory for the first time, the obligation to appoint the CH REP starts immediately and the transition period does not apply.
>> What can Thema do?
STRATEGIC REGULATORY CONSULTING
The MDR or IVDR classification assessment is an established regulatory strategy tool.
Through this detailed report describing the method and result of device classification, the correct procedure for marketing the device in Switzerland can be identified.
With the pre-screening of documents, Thema’s experts analyse product and system documentation in detail, suggesting the necessary changes to comply with the regulations of the territory.
Thema manages the entire process of manufacturer and device registration with Swissmedic, pending the creation of the Swiss SWISSDAMED database.
Thanks to CompLife Swiss, the Group’s Swiss subsidiary, Thema has all the necessary prerequisites to perform the function of CH REP and meet the regulatory obligations of MedDo and IvDO. In particular, Thema has an ISO 13485:2016-compliant quality management system that takes Swiss regulatory requirements into account and has an appropriate insurance in the event of damage due to a defective product. Thema’s expert team verifies the adequacy of the non-Swiss manufacturer’s Classification, Technical Documentation and Declaration of Conformity and processes.
For Manufacturers who have a Quality Management System compliant with ISO 13485:2016 is not enough to fullfill the IvDO requirements. Thema Experts can offer support in the implementation of business processes (e.g. labelling, packaging, post-market surveillance and vigilance) in order to make them sustainable in the event of a Regulatory Authority inspection.
With the appointment of CH REP, Thema is also delegated to report to Swissmedic any adverse events that have occurred or are likely to occur and to keep records of complaints and market actions.
With Thema, everything you need
The market access requirements are numerous, but with its services, Thema is the reliable and professional partner that can become a one-stop shop for marketing Medical Devices in Switzerland.
For more information see CH REP services tab