OVERVIEW

The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone the CE marking deadline for Class I devices by another four years to 2024.

POSTPONEMENT OF CE

The postponement of CE marking does not imply that Class I device manufacturers can delay the compliance with QMS requirements applicable as per the EU MDR for Devices. The QMS requirements requires manufacturers of Class I devices to have a post market surveillance, risk management, prepare post marketing surveillance report, regulatory compliance, document storage and retention, UDI and labeling, general safety and performance requirements and other aspects in place as per the May 2020 deadline. The technical documentation for Class I devices can be submitted by 2024 as per new schedule, once approved by the EU parliament.

CLASS I DEVICES

The class I devices may include software devices already registered as Class I, reusable surgical devices and devices that were re-classified as per new EU MDR for devices.

Global Regulatory Partners will keep posting updates on new MDR and IVDR initiatives in Europe as they become available.

To learn more about QMS implementation for your organization and devices as per EU MDR, please write to us at info@globalregulatorypartners.com