As of May 26th, 2020, companies producing medical devices will be required to nominate a person responsible of regulatory compliance. The PRCC supervises and controls the manufacture of devices and carries out the post-market surveillance and vigilance activities. In particular, large manufactures, that is to say enterprises which employ at least 50 people and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million, must have available the PRRC within their organization. Instead, micro and small enterprises and the authorized representatives are not required to have the PRRC within their organization but must have such person “permanently and continuously at their disposal”. But what is his role and responsibilities?
Fonte: IPSOA – Informazione quotidiana su fisco, lavoro e pensioni, bilancio, gestione d’impresa e finanziamenti.