EU MDR Regulatory Strategy
EU MDR Transition Timeline and Regulatory Strategy
Years in the making, the European Union has now transitioned from the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) to the European Medical Device Regulation (MDR) (2017/745).
The new regulation introduces major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market. Despite the deadline, many medical device manufacturers have yet to prepare for compliance with these new requirements or organize their regulatory transition strategies.
As of May 26, 2021, manufacturers should have already started complying with the EU MDR, at least for the transitional provisions requirements of Article 120(3) for devices placed on the market today with a valid CE certificate under the Directives.
Our team of medical device regulatory affairs and quality management system (QMS) consulting experts will start with a gap analysis of your QMS, Technical Documentation, and Clinical Evaluation documentation. They will then guide you through the implementation of EU MDR requirements to ensure your organization is compliant with the EU MDR, audit-ready, and can successfully place devices in the EU market.