Roles of Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under Article 15 of the EU Medical Device Regulation (MDR). It requires manufacturers and authorized representatives to appoint a qualified individual with expertise in regulatory affairs...
EU MDR Implant Card Requirements: Everything You Need to Know
An implant card (IC) is a patient-specific document that accompanies an implantable medical device. It provides essential information on the person’s implanted medical device. It is required by Article 18 of the EU medical device regulations (MDR). Moreover, it...
5-Step Guide to Obtaining Single Registration Number (SRN)
Single Registration Number (SRN) under the EU MDR is a unique identifier assigned to economic operators. The SRN is assigned once the economic operators are registered in the EUDAMED database. It serves as a critical regulatory tool for ensuring traceability,...