After the MDR implementation, there is a need to update the MRA, which is impossible until an Institutional Agreement (InstA).
Therefore, to cope up with the new MDR, Switzerland has updated its Swiss MedDo. The updated version of this Swiss MedDo requires non-Swiss manufacturers to appoint a Swiss Authorized Representative to market their devices in the Swiss territory.
According to Swiss MedDo Article 51, the Swiss Authorized Representative should support Manufacturer in the following:
- Prove compliance with the registration obligations in Switzerland as per the revised MedDo.
- Prove compliance with MedDo’s device labeling requirements
- Giving access of the medical device’s samples to the Competent Authority.
- Cooperating with the Competent Authority to take any preventive or corrective action.
- Informing the manufacturer about complaints from patients, users, and healthcare professionals.
- Ensuring that Technical Documentation, EU Declaration of Conformity, and a relevant certificate is available for authority review
- Demonstrating device’s conformity by providing all the necessary documentation and information upon Competent Authority’s request.
What can we do for You?
- ensures Swiss market access as your Authorized Representative
- offers to take the role as Person Responsible for Regulatory Compliance (PRRC) in Switzerland
- supports you in fulfilling labelling requirements and registration procedures for the Swiss market
- supports you in the handling of market feedback and your communication with CAs
- cooperates with your regulatory affairs consultant
- supports you to obtain the Swiss Unique Identification Number “CHRN”
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APPOINT TSQ FOR ALL YOUR MARKET ACCESS NEEDS
It is challenging job for companies to arrange and liaison with three different entities to comply with the requirement in these territories. Appointing TS Q&E, the requirement for having three different authorized representatives can be managed under one umbrella.
TS Q&E can offer support for manufacturers to appoint Authorized Representatives in Europe, Switzerland and UK.