Belangrijke deadlines voor het overzetten van legacy-apparaten naar MDR-conformiteit.

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 EU MDR transition 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). Learn more about the ISO 13485 QMS software. As Certification Experts and AR Experts, we stand ready to assist you in this essential aspect of compliance.

MDD to MDR transition in 2024

Looking ahead to September 26, 2024, manufacturers must have entered into a written agreement with a Notified Body for the transition from MDD to MDR. 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 during the EU MDR transition period. Learn more about MDR notified bodies.

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 (MDD) to MDR standards. It ensures compliance with the regulatory requirements and managing communication with European Competent Authorities. As the deadlines for the EU MDR transition approaches, we urge manufacturers to take proactive steps to meet these obligations and safeguard their products’ compliance.

Want to know more about medical devices? Get in touch with our experts, they can help you with all your questions and can get set you up to get CE mark for your medical device.