Obligations of the Switzerland AR Responsibilities
1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out.
2. Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for a period as defined in the section «Records» of this agreement.
3. Register itself on the electronic system «EUDAMED» and obtain the Single Registration Number (SRN)
4. Verify that the manufacturer has complied with the registration obligations in EUDAMED by entering the UDI core data elements (as per Article 27 of (EU) 2017/745) and has assigned and entered in Eudamed the Basic UDI-DI Information of the devices (as per Article 29 of (EU) 2017/745).
5. In response to a request from the competent authority, provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official language determined by the competent authority.
6. Forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
7. Cooperate with competent authority on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
8. The AR is equally liable for any defective device in the Swiss market when either of the parties does not fulfil their obligations in accordance with the Ordinance. Therefore, it is important to consider the inclusion of AR in the corresponding processes and management reviews as deemed necessary.
9. Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device.
10. AR shall ensure that it has permanently and continuously at its disposal at least one the person responsible for regulatory compliance who possesses the required expertise (as per article 52 of MedDO / article 15 of (EU) 2017/745) regarding the regulatory requirements for medical devices in Switzerland. The PRRC shall comply with its responsibilities as defined in the Ordinance.
11. The PRRC of AR is responsible to verify the quality functions of the manufacturer (if conformity of the device is checked as per the QMS, the PMS obligations, reporting obligation of incidents, issuance of the signed statement confirming the safety of the investigational device). This could be facilitated by allowing the PRRC of AR to have access to the QMS documentation. For example, the PRRC of AR could be part of the internal audit of the manufacturer.
12. The AR is legally liable for defective devices on the Swiss market on the same basis as, and jointly and severally with, the manufacturer when the manufacturer has not complied with its obligations according to article 10 of (EU) 2017/745