For the foreign manufacturers who want to place their products on the Swiss medical device market, it is necessary to appoint a Swiss Authorized Representative. However, an agreement must be ensured between the manufacturer and the Representative before the Representative’s appointment.
Need of the Swiss Authorized Representative
For the non-Swiss manufacturers, hiring a Swiss Authorized Representative is necessary to deal efficiently with the Swiss Authorities. It is also important to note that a bilateral agreement between the EU and Switzerland has allowed the mutual recognition of conformity assessment and free market access to medical devices. The deal has also enabled the recognition of coordinated market surveillance and safety-related information. In the light of this bilateral agreement, the importance of hiring a Swiss Authorized Representative becomes much more profound.
The Role of The Swiss Authorized Representative
The Swiss Authorized Representative will work as an international proxy to the foreign manufacturer and ensure product safety. If any defect is found in the manufactured medical device, the Authorized Representative will also be held liable for that defect alongside the product’s manufacturer.
Appointment of the Swiss Authorized Representative
A manufacturer without a registered office in Switzerland and who cannot be held responsible for his product’s placement in the market by a subsidiary will have to appoint a Swiss Authorized Representative.
Appointment of the EU Authorized Representative
A Swiss medical device manufacturer will also have to appoint an EU Authorized Representative possessing the domicile of an EU member state.
Requirements and Obligations to be Fulfilled by the Swiss Authorized Representative
The Swiss Authorized Representative has the following two requirements
- He has to work as the contact person between the manufacturer and the Swiss Authorities
- He should have access to at least one person having expertise in regulatory affairs. This legal expert is also known as PRRC (Person Responsible for Regulatory Compliance).
The Role of the Swiss Authorized Representative
- He has a significant role in controlling medical devices and post-market surveillance
- He is also responsible for complying with the duties of the Authorized Representative. He can be held accountable for violating the duties of the Authorized Representative
- He must appoint a PRRC. However, he can complete this task with the help of an external service provider.
Liabilities of the Swiss Authorized Representative
According to the Swiss Product Liability Act
According to the Swiss Product Liability Act, the manufacturer is responsible for any defects present in the product.
According to the Swiss Ordinance on Medical Devices
It extends the liability to the Swiss Authorized Representative, who is jointly and severally responsible with the manufacturer in terms of product defects. This liability of the Authorized Representative is mandatory.
Contractual Indemnification Clauses
It is allowed for the manufacturer and the Authorized Representative to agree to the clauses of the contractual indemnification agreement. For example, the manufacturer can indemnify his appointed Authorized Representative against the claims made by the third-party if the Authorized Representative is not at fault.
Ensuring the Integrity of Liability Claims
This requires the manufacturers to take out liability insurance while having sufficient coverage. The obligation ought to ensure compensation for the damages arising from the non-compliant medical devices. It is necessary to note that the contract made between the manufacturer and the Authorized Representative cannot waive off the obligation of liability insurance. However, the manufacturer is allowed to take an undertaking regarding the payment of the insurance costs to this Authorized Representative.
Necessities for the Authorized Representative before Signing-up the Agreement
The Authorized Representative must do the following before signing up the agreement with the manufacturer
- He should obtain clarification about his function concerning the patient’s protection
- He should get clarification about characteristics of tasks
- He should perform due diligence about the particulars of the contract.
Designated Responsibilities of the Manufacturer
The manufacturer’s position requires him to rove and document the responsibility and classification of his products along with QMS management and QMS introduction. By virtue of the contract, the manufacturer will also be obliged to show complete compliance to his legal duties, such as
- Affixing the CE mark
- Assigning the UDI number
- Writing and translating the IFUs (Instructions for Use) in the required languages of Switzerland.
Designated Responsibilities of the Authorized Representative
The assigned roles and responsibilities of the Swiss Authorized Representative are pretty limited. The Representative depends on the manufacturer to fulfill his obligations and ensure that all the documents are up-to-date. According to the Swiss requirements, the Authorized Representative has also confirmed that the manufacturer competes for his duty.
Obligations for Retention, Reporting, and Confidentiality
In order to help the Authorized Representative fulfill his contractual duties, the manufacturer must supply his Authorized Representative with complete and extensive information.
Retaining of the Technical Documentation by the Authorized Representative
Although the Swiss Ordinance on Medical Devices has not indicated the scope and duration of the Authorized Representative, he should ensure to maintain the commercial record for at least ten days.
Retaining of the Technical Documentation by the Manufacturer
According to the Swiss Ordinance on Medical Devices, the manufacturer is legally obliged to do the following
- Maintenance of technical documentation for ten to fifteen years
- Declaration of certificate conformity for ten to fifteen years. This also includes amendments and supplements.
Other Obligations to be Added into the Agreement
The agreement made between the manufacturer and the Swiss Authorized Representative must mention
- The confidentiality and the obligations of the Authorized Representative
- The prohibition of the Authorized Representative for not contacting the Authorities on his own before consulting the manufacturer.
Completion of the Agreement
The manufacturer and the authorized Representative’s agreement can be made either for a definite or indefinite period. However, it is essential for both the parties to keep the unstable relationships between the EU and Switzerland in mind while making any such agreement. It is also vital that the length of the said notice should be long enough till a suitable Authorized Representative can be found.
TSQ Asia Can Help Medical Device Manufacturers with Searching a Swiss Authorized Representative
The relations between the EU and Switzerland have gone through many changes recently. Therefore, medical device manufacturers need to understand the complexities of these relationships to market their products efficiently within the Swiss markets. In this scenario, TSQ and Asia are assisting the medical device manufacturers to find a suitable Authorized Representative to help the manufacturer comply with all the legal requirements. TSQ and Asia can also assist these stakeholders in signing up a fair contract and initiating a smooth marketing process for the medical devices to be placed in the Swiss medical device market.