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There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three (03) major economic operators (EOs) in the supply chain are the Swiss Authorized Representative (Swiss AR/CH-Rep), importers, and distributors.
The Swiss AR plays a critical role in ensuring only safe devices are placed in Switzerland. The importers and distributors are mainly involved in the storage and transportation, and the Swiss ARs play no role in the storage or transportation of the devices. The Swiss AR and importers must register with Swissmedic and obtain a CHRN number, whereas the Swiss distributors need not register with the Health Agency.
On a mandatory note, the Swiss AR must have a written mandate with the manufacturer, whereas such mandate is not a regulatory requirement for the importers and distributors. The importers and distributors may agree to have such mandate with their manufacturer as per mutual understanding. The Swiss AR must appoint a Person Responsible for Regulatory Compliance (PRRC) , and the importers and distributors do not require such a role.
The distributor is not obliged to archive or have any device documents. On the other hand, the importers must have access to declarations of conformity and certificates. The Swiss ARs must retain the device technical documents along with the declarations of conformity and certificates. Such documents shall be available for ten (10) years after the last device is placed on the market. In the case of implantable devices, they should be archived and made available for 15 years.
Post-market Obligations
All the EOs, i.e., Importers, Distributors, and the Swiss ARs are responsible for tracing the devices placed in the Swiss market. The devices shall be traceable for at least ten (10) years from the date of placing the last device in the market. In the case of implants, the traceability information shall be available for 15 years.
The Swiss AR ensures that all the reports on serious incidents, safety corrective actions, and related trend reports are submitted to Swissmedic. All economic operators must, without fail, forward any complaints or reports of suspected incidents to the manufacturer. The importers and distributors must maintain an updated complaints list, and the Swiss AR must have access to technical documentation, including the Post Market Surveillance (PMS) data.
The Swiss AR is not obliged to take part in the complaint investigation. Though not a Regulatory obligation for the Swiss AR, the manufacturers and the Swiss AR may discuss, mutually agree, and include the obligations in the written mandate. However, the Swiss AR must co-operate with the Swissmedic on corrective and preventive actions. Being part of the supply chain, the importers and distributors are obliged to obtain and share the required information with the manufacturer or the Swiss AR to carry out the complaint investigation. The importers and distributors must also support executing corrective and preventive actions such as product recalls.
The manufacturers should make a point to identify the stakeholders involved in the supply chain and identify each stakeholder's role. They should ensure that the roles and responsibilities of each of the stakeholders are agreed upon during the business discussion, and a written agreement for the same is in place. The manufacturer can also ask the (EOs) for a quarterly or half-yearly summary report to keep track of all the activities that they carry out. The manufacturer should periodically monitor if the EOs are fulfilling their roles and are always compliant.
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