Economic Operators’ (EOs) Obligations under Swissmedic’s Medical Device Ordinance (MedDO)
Various Economic Operators (EOs) play an important role in the delivery of devices to the point of usage in the device supply chain. The Swiss Medical Device Ordinance (MedDO; SR 812.213) has defined the functions and responsibilities of each of these EOs due to the relevance of each role. The Swiss Authorized Representative (Swiss AR/CH-Rep), importers, and distributors are the supply chain’s three key economic operators (EOs).
The Swiss AR is important in ensuring that only safe devices are installed in Switzerland. The storage and transit of the devices are primarily handled by the importers and distributors, with the Swiss ARs having no involvement. Swiss ARs and importers must register with Swissmedic and get a CHRN number, whereas Swiss distributors are not required to do so.
The Swiss AR is required to have a written mandate with the manufacturer, whereas importers and distributors are not need to have such a mandate. According to mutual agreement, importers and distributors may agree to have such a mandate with their producer. Importers and distributors are not required to appoint a Person Responsible for Regulatory Compliance (PRRC) by the Swiss AR.
The distributor is not required to keep any device documents or to preserve them. Importers, on the other hand, require access to conformity declarations and certificates. The technical paperwork for the devices, as well as the declarations of compliance and certificates, must be kept by the Swiss ARs. Such documents must be made available for ten (10) years after the last device is released. Implantable devices should be stored and made available for a period of 15 years.
Obligations after the sale
All EOs, including importers, distributors, and Swiss ARs, are responsible for tracing devices sold in Switzerland. The devices must be traceable for a minimum of ten (10) years after the last device is placed on the market. The traceability information for implants must be available for a period of 15 years.
All reports on major accidents, safety corrective actions, and relevant trend reports are reported to Swissmedic by the Swiss AR. Any complaints or notifications of suspected events must be forwarded to the manufacturer by all economic operators. The Swiss AR must have access to technical documentation, including Post Market Surveillance (PMS) data, and importers and distributors must keep an updated complaints list.
The Swiss AR is not obligated to participate in the investigation of the complaint. The manufacturers and the Swiss AR may discuss, mutually agree, and include the requirements in the written mandate, even if it is not a Regulatory requirement for the Swiss AR. The Swiss AR, on the other hand, must work with the Swissmedic on corrective and preventive measures. Importers and distributors are expected to gather and share the necessary information with the manufacturer or the Swiss AR in order to conduct the complaint investigation. Importers and distributors must also assist the implementation of remedial and preventative actions like product recalls.
Manufacturers should make it a point to identify all of the stakeholders in the supply chain and their respective roles. They should make sure that each stakeholder’s tasks and obligations are agreed upon throughout the business talk and that a documented agreement is in place. The manufacturer might also request a quarterly or half-yearly summary report from the (EOs) to keep track of all of their actions. The manufacturer should check in on the EOs on a regular basis to make sure they’re doing their jobs and staying compliant.
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Category: Medical Devices.
Key Words: Medical devices, Economic Operators, Swlssmedic, Medical Device Ordinance, Regulatory Affairs, Maven.
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