The Medical Devices Directive (MDD) is quickly reaching obsolescence and will be replaced by the Medical Device Regulation (MDR) starting May 20, 2020. Transition is underway in the EU, and all companies with CE certificates will be required to comply with the new regulation by the end of May 2024 or sooner, depending upon certificate expiry.
Under MDR, the requirements for quality management systems have changed. The transition from MDD will affect organizations certified to ISO 13485:2016 Medical Devices – Quality management systems. Understanding the new requirements, and which requirements ISO 13485:2016 fully cover, partially cover and do not cover will help medical device manufacturers to comply with MDR.
This webinar will provide an overview of the similarities and differences between the quality management system requirements of ISO 13485:2016 and of MDR.
- Introduction to the differences between ISO 13485 and MDR quality management system requirements
- Overview of the current timeline for MDR implementation
- MDR clauses not covered by 13485:2016
- MDR clause partially covered by ISO 13485:2016
- MDR clauses covered by ISO 13485:2016
This webinar is aimed at ISO 13485 certified clients and any other interested parties.
Cost: No Charge
Greg Jones – SGS Technical Director Medical Device NAM
For more information, please contact:
t: +1 201 508 3000