(1) Compliance with Article 31 and verification of Legal Manufacturer (LM) compliance with Articles 27 and 29; (2) Provision of all documentation to demonstrate device conformance to the Competent Authority (CA); (3) Forward to the LM all requests by a CA of the Member State in which the EC-REP is located, and verification to the CA that the LM has responded; (4) Cooperation with the CAs on CAPAs; (5) Termination of the mandate if the LM acts contrary to its obligations
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POLLASTRI Matteo
(1) Communication of all potential incidents to the Legal Manufacturer to ensure "on-time" vigilance reporting