New MDR requirements to be implemented before May 26, 2021
PMS, ECONOMIC OPERATORS AND & VIGILANCE
Regardless if your medical device will remain CE marked under the MDD after May 26, 2021, your company must have procedures and documentation in place to be in compliance with MDR´s requirements concerning Post Market Surveillance (PMS), Economic Operators and Vigilance at this date.
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
MDR requires that all Medical Device Responsible Manufacturers assign a Person Responsible for Regulatory Compliance (PRRC). If your company does not have a suitable candidate for PRRC we can be assigned.