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.
Understanding the quality system requirements and where ISO 13485:2016 fully cover, partialy cover and do not cover will aid manufacturers in compliying with the 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.
ISO 13485 certified clients as well as any other interested parties.
Cost: No Charge
Transition to MDR is underway in the EU. The MDD ends in May 2020. All companies with CE certificates will be required to comply with the new regulation before the end of May 2024 or sooner depending upon certificate expiry. ISO 13485 has changed to the 2016 version of the standard. The quality system requirements of the MDR have changed from those in the MDD.
For information about the SGS Accreditations and Licenses see https://www.sgs.com/en/life-sciences/medical-devices/regulatory-certification