Foreign manufacturers willing to place their products on the Swiss medical device market must appoint a Swiss Authorized Representative. Before selecting the Swiss Authorized Representative, an agreement must be made between the manufacturer and the Representative.
Need of the Authorized Representative
A bilateral agreement between Switzerland and the European Union allows mutual recognition of conformity assessment and free market access to medical devices. It also enables the recognition of conformity assessments, and safety-related information, and coordination of market surveillance.
Now, the continuation of this agreement is dependent on the progress of the institutional framework agreement. And for the European manufacturers who are willing to place their manufactured devices into the Swiss market will have to appoint a Swiss Authorized Representative. This representative will help them in dealings with the Swiss Authorities.
Role of the Swiss Authorized Representative
Working as an international proxy to the foreign manufacturer, the Swiss Authorized Representative shall be responsible for product safety. Along with the manufacturer, he will also be held liable for any defects in the manufactured devices.
Appointing Authorized Representatives in Switzerland and EU
A manufacturer who does not have a registered office in Switzerland and cannot hold the responsibility for his product’s placement in the market by a subsidiary has to appoint a Swiss Authorized Representative.
Likewise, a Swiss medical device manufacturer will also be obligated to Swiss manufacturers willing to place their devices in the EU market. A Swiss manufacturer will have to appoint an EU Authorized Representative having domicile of an EU member state.
Requirements to be fulfilled by the Swiss Authorized Representative
Following are the requirements of the Swiss Authorized Representative:
- He is the contact person between the manufacturer and the Swiss Authorities
- Although he can represent himself as a legal entity, he should have access to at least one person who has expertise in regulatory affairs. This person is also known as Person Responsible for Regulatory Compliance (PRRC).
Role of the Responsible Person
- The responsible person has a central role in post-market surveillance and the control of medical devices
- He is personally responsible for showing compliance with Authorized Representative’s duties. He can be held liable for the violation of these duties
- The Swiss Authorized Representative must designate a PRRC. However, he can select this function from an external service provider.
Liability of Authorized Representative
Liability of Authorized Representative according to Swiss Product Liability Act
The Swiss Product Liability Act holds the manufacturer responsible for any defects in the product.
Liability of Authorized Representative according to Swiss Ordinance on Medical Devices
The Swiss Ordinance on Medical Devices extends the liability to the Swiss Authorized Representative. According to the Ordinance, the Authorized Representative is jointly and severally liable with the manufacturer for product defects.
The liability of the Authorized Representative is mandatory, and the contract limited or waived it off.
Contractual Indemnification Clauses
The manufacturer and the Authorized Representative can agree upon the clauses of the contractual indemnification agreement. E.g. the manufacturer can decide to indemnify the Authorized Representative against third-party claims, given the condition that the Representative is not at fault.
Ensuring the Liability Claims
Ensuring the liability claims requires the manufacturer and the Authorized Representative to take out liability insurance having ample coverage. For the damages that arise from the non-compliant medical devices, the obligation shall ensure compensation.
The contract cannot waive off this obligation. However, the manufacturer may take an undertaking for paying the insurance costs to the Authorized Representative.
Things to do for The Authorized Representative before Signing the Agreement
Before he signs the agreement with the manufacturer, the Authorized Representative must
- Obtain clarification about his function regarding patients’ protection
- Obtain clarification about characteristics of tasks
- Perform due diligence regarding the particulars of the contract.
Clarification between the Responsibilities of the Manufacture & the Authorized Representative
Designated Responsibilities of the Manufacturer
The manufacturer plays a central role in product manufacturing, marketing, and placement. Therefore, his position requires that he prove and document his product’s responsibility and the correct classification of his product. Also, the QMS introduction and QMS management are his responsibilities.
The manufacturer will also be obliged by the contract to the Authorized Representative to show full compliance to his legal duties. For example:
- Affixation of the CE mark
- Assigning the UDI number
- Writing the IFUs (Instruction for Use) and their translation into the required languages of Switzerland, etc.
Designated Responsibilities of the Authorized Manufacturer
The role and responsibilities of the Swiss Authorized Representative are limited. He depends upon the manufacturer regarding fulfillment of his obligations and keeping the documents up-to-date.
Moreover, the Authorized Representative shall also ensure that the manufacturer is taking measures regarding the Swiss requirements.
Obligations Regarding Retention, Reporting, & Confidentiality
To help the Authorized Representatives with their contractual duties, the manufacturer has to supply the Representative with extensive documentation.
Retaining of the Technical Documentation by the Manufacturer
The manufacturer is legally obliged by The Swiss Ordinance on Medical Devices to maintain the following for ten or fifteen years:
- Technical documentation
- Declaration of certificate conformity (including amendments and supplements).
Retaining of the Technical Documentation by the Authorized Representative
The Swiss Ordinance on Medical Devices has not indicted the duration and retention scope of the Authorized Representative. But since this is a commercial undertaking, he must keep a commercial record at least for ten years.
Other Obligations to be added to the Agreement
The agreement between the manufacturer and the Swiss Authorized Representative should also mention
- The Authorized Representative’s confidentiality and obligations
- That the Authorized Representative should not contract Authorities on his own and without consulting the manufacturer.
Conclusion of the Agreement
The manufacturer and the authorized representative’s agreement can be made for a definite or an indefinite period. While regulating the notice period, both parties should consider the unstable relations between the EU and Switzerland.
However, this notice period should be long enough so that a suitable Authorized Representative can be found.
TSQ & E can help with finding a Suitable Swiss Authorized Representative
Recently, many changes have been made in the relations of Switzerland and the EU. The manufacturers have to understand the intricacies of these relations so that they do not find any difficulty marketing their products in the Swiss markets. TSQ and E are helping these manufacturers find a suitable medical device Authorized Representative who can help them comply with all the legal requirements. TSQ and E can also help both of these parties to sign-up a suitable contract.
