MDR & IVDR
MDR & IVDR Transition timelines for legacy Medical Devices – Not without Risks and undue Burden
The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has prompted the implementation phase of this new and significant legislation.
MDR & IVDR
Two years ago, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.
The Most Important Thing Companies Must Consider
Simply put, the most important thing you can do is plan, plan, and plan. Companies need to act quickly and ensure that they are taking all appropriate steps to understand and address MDR. This is not something that any organization should leave to the last minute – without a sensible amount of preparation, you’ll likely find yourself in deep trouble. You need a sufficient amount of time to evaluate product portfolios and gauge if the clinical data that you currently have captured will at a minimum meet, and hopefully exceed, the new requirements.
