欧盟PRRC：第15条要求

Who can be your PRRC for the EU? Article 15 of the MDR and IVDR requires one for every manufacturer and every authorized representative. And not just anyone qualifies. Start with company size. Among manufacturers, only micro and small enterprises, under 50 staff and up to 10 million euros, may use an outside PRRC under contract. Medium and large manufacturers need one inside their own organization, as an employee. The person must be qualified: a degree in law, medicine, pharmacy, engineering or another relevant science, plus one year of regulatory or quality experience with medical devices. Or four years of that experience. Outside the EU, you need two different people. MDCG guidance says your PRRC and your authorized representative's PRRC cannot be the same person, even within one group. Start with three things. One: check your company size. Two: keep proof of your PRRC's degree and experience. Three: register the PRRC in EUDAMED and update any change within a week. The right person, on record. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.