5 EU MDR Medical Device Software (MDSW) Requirements
EU MDR defines medical device software (MDSW) as a software with medical purpose, whether standalone or embedded in a device. MDSW is regulated as an active medical device. Its classification is primarily determined by Rule 11 of Annex VII. Most diagnostic or...
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...