Swiss IvDO: Fast-Approaching Deadlines for IVD Manufacturers

As we’ve previously reported for non-IVD devices, under the new Swiss Medical Devices Ordinance (MedDO), manufacturers located outside of Switzerland must designate a Swiss Authorized Representative (CH-REP) and importer (CH-Importer). While the MedDO mostly emulates the EU MDR, those manufacturers wishing to place their devices on the Swiss market must ensure that the CH-REP and CH-Importer are identified in accordance with the MedDO within specific device risk class-based transition deadlines. 

Fast-Approaching Deadlines for IVD Manufacturers in Accordance with IvDO

The Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) establishes the same requirements for IVDs, with some fast-approaching critical compliance deadlines. Depending upon whether your IVDs are legacy devices (i.e., devices CE marked under the EU IVDD) or CE marked under the IVDR, and the manufacturer’s location, the following dates represent the deadlines applicable for CH-REP and CH-Importer identification discussed below. 

Make Sure You’re Compliant with Swiss IvDO

IVD manufacturers located outside of Switzerland should already be complying with the following requirements which entered into force on 26 May 2022: 

• • Designation of a CH-Importer and identification (name, place of business and contact address) of the CH-Importer on the device or on its packaging or in a document accompanying the device. 
  • Where the manufacturer is located outside the EU/EEA or is without an EC-REP: 

• • Designation of a CH-REP 
  • Identification (name and address of the registered place of business) of the CH-REP on the IVD labeling, its outer packaging, or in the instructions for use (IFU).

Device Risk Class-Based Transition Deadlines

The following requirements become mandatory from the indicated dates, where the manufacturer of the devices described is located inside the EU/EEA or has an EC-REP: 

New Swiss IvDO: Fast-Approaching Deadlines for IVD Manufacturers

Class B and C IVDs represent approximately 70% of all IVDs placed on the market. Manufacturers of such devices being placed on the Swiss market, therefore, have little more than four months to ensure that a CH-REP has been assigned with appropriate contracts in place, and to modify device labelling or establishing adequate documentation clearly identifying the CH-REP is provided with the device. Since it can take 4-6 months to modify labeling and review/sign contracts, these manufacturers should not wait until the 11th hour to designate their Swiss Authorized Representative and be in accordance with IvDO! The situation is even more urgent for Class D device manufacturers. 

Swiss Authorized Representation & Importer Services

Manufacturers placing medical devices on the Swiss market must ensure that the CH-REP and CH-Importer are identified in accordance with Swiss IvDO within specific risk class-based transition deadlines. We encourage you to be aware of the roles and responsibilities of the CH-REP and CH-Importer and learn more on our Swiss Authorized Representation and Importer services. 

Contact us with questions or to proceed with the steps to get in conformity with Swiss IvDO before the specific device risk class-based transition deadlines.