2024 To-Do list for legacy devices transitioning to MDR

The European Commission published Regulation (EU) 2023/607 in early 2023 which specifies conditions for extending the deadlines for medical device manufacturers transitioning from MDD to MDR and removing the “sell off” period. The regulation was published to minimize impact on healthcare services caused by device shortage, to prevent unnecessary disposal of safe devices and to maintain a high level of public health protection in EU and EEA.

Can Your Device Benefit from the Extended Transitional Period?

It is important to note that not all medical device manufacturers can benefit from the extended transitional period, as it only applies to legacy devices requiring conformity assessment by a Notified Body under MDR. The extended transitional periods are currently set to May 2026, December 2027, and December 2028, depending on the type and risk-based classification of the legacy device.

To-Dos for Legacy Device Manufacturers in 2024

If you are a manufacturer of a legacy device subject to conformity assessment by a Notified Body under MDR, you will need to complete the following tasks in 2024 to benefit from the extended transitional period:

• Lodge an application for conformity assessment with your Notified Body by May 26^th, 2024
• Sign a written agreement with your Notified Body by September 26^th, 2024
• Establish a quality management system (QMS) in accordance with MDR by May 26^th, 2024

The transitional period will end on May 26^th, 2024 if the above conditions are not met.

General Conditions for Transitional Period

In addition to the above, you must also ensure that these general conditions are met during the transitional period:

• Your legacy device continues to comply with relevant requirements of MDD or AIMDD
• Your legacy device does not undergo any significant change to its design or intended purpose
• Your legacy device does not present any unacceptable risk to public health or the health and safety to patients, users or any other person

Interested in delving deeper into the technical aspects of the extended transitional period? Explore this Q&A published by the European Commission. If you have any additional inquiries or need further assistance, don’t hesitate to get in touch with our team at Key2Compliance. We’re here to help!