1. Overview of Key Certificate Timelines
Under the modified MDR transition arrangements, manufacturers of legacy devices are granted additional time to bring their medical products into full compliance, provided they satisfy specific requirements. The transition timeline depends on the risk classification of the device under EU rules.
For Class III and Class IIb implantable devices, the transition extension runs until December 31, 2027. For Class IIb non-implantable, Class IIa, and Class I sterile/measuring devices, the deadline has been extended to December 31, 2028.
2. QMS Prerequisites for Extension Approval
Manufacturers cannot simply wait out the extended transition period. To benefit from the extension, the manufacturer must establish an ISO 13485 compliant Quality Management System by May 2024, and have formally lodged an application with a Notified Body by October 2024.
3. Step-by-Step Submission Mapping
Successfully navigating the transition requires careful document preparation: compile your legacy device certifications, map out your QMS transition schedule, draft a Notified Body service agreement, and update your CER (Clinical Evaluation Report) files.
Hi, this is a comment.
To get started with moderating, editing, and deleting comments, please visit the Comments screen in the dashboard.
Commenter avatars come from Gravatar.