Important Deadlines for Transitioning Legacy Medical Devices to MDR Compliance

Published in: Medical Devices
Published on: 2 April 2024

As we approach the deadlines outlined by the Medical Device Regulation (MDR) for legacy devices, it is important for manufacturers to understand the critical steps required for compliance. The deadlines of May 26, 2024, and September 26, 2024, mark significant milestones in this transition process.

Firstly, by May 26, 2024, the transition period expires for legacy devices that do not meet the conditions for the application of new transition periods. This means that these devices must align with MDR requirements. Manufacturers are obligated to submit an application to a Notified Body for MDR conformity assessment. Crucially, for manufacturers from outside the European Union, the presence of a mandate agreement with European Authorised Representative (EC Rep for Medical Devices) will be inspected by the Notified Body during this process.

Furthermore, by the same deadline, manufacturers must have implemented an MDR-harmonized Quality Management System (QMS). As Certification Experts and AR Experts, we stand ready to assist you in this essential aspect of compliance.

Looking ahead to September 26, 2024, manufacturers must have entered into a written agreement with a Notified Body. This includes having a signed mandate agreement for European Authorised Representation with an AR company, which is a requirement assessed by the Notified Body during conformity assessment. It is essential to have all necessary documents prepared before this date to avoid any delays in the conformity assessment procedure.

In conclusion, having an European Authorised Representative/EC Rep who can assist you in getting fully compliant with the MDR requirements, will streamline the transition of your legacy devices to MDR standards. It ensures compliance with the regulatory requirements and managing communication with European Competent Authorities . As the deadlines approach, we urge manufacturers to take proactive steps to meet these obligations and safeguard their products’ compliance.

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Rebecca Brust

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