MDD TO MDR – THE TRANSFER PROCESS

May 26th 2020 is rapidly approaching and we still await high impact guidelines. However, this does not mean that you can sit around and wait, doing nothing. In an ideal world, you should already have formulated a comprehensive step-by-step transfer plan and be implementing it right now.

New MDR requirements to be implemented before May 26, 2020

PMS, ECONOMIC OPERATORS AND & VIGILANCE

Regardless if your medical device will remain CE marked under the MDD after May 26, 2020, 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.