2024 Outlook: Medical Devices Regulation
Amy Eikelenboom
Co-Founder at NAALA
Published on 6 February, 2024
By: Amy Eikelenboom – Co-Founder at NAALA
Published on 6 February, 2024
As we embarked on a new year, it is our responsibility to ensure that you have crucial 2024 dates noted and emphasized in your freshly minted 2024 calendar. If you are utilizing the extended transition period, the following dates are important to take note off:
- An application must be lodged for the MDR conformity assessment and a MDR QMS must be in place by May 26th, 2024.
- By September 26th, 2024 a written agreement with a Notified Body must be in place.
Where do these dates come from?
As you may know, the amendment to the Medical Devices Regulation from March 20th, 2023, had two great implications:
It extended the Transition period, and
Transition period: Devices previously certified under the Medical Devices Directive (the predecessor of the MDR) benefit from a transition period to allow time for the preparation and Notified Body confirmity assessment under the new Regulation.
It eliminated the “sell-off” provision.
Sell-off provision: The sell-off period was the period allowing devices compliant under MDD to stay on the market or be put into service without any time limitations.
The decision to prolong the transition period stems form concerns that notified bodies might face challenges in ensuring timely conformity assessment and that manufacturers might face challenges in preparing their technical documentation by the deadline of May 26, 2024. This could potentially have led to shortages of crucial medical devices after May 26, 2024, due to ongoing supply concerns if not all devices were certified under the MDR in time.
The amended Regulation allows for the extension of the original deadline when medical devices meet specific conditions required in order to be able to make use of this extended deadline.
The lenght of the extension depends on the risk class of the medical device, applying exclusively to legacy devices – those with a Medical Device Directive (MDD) certificate before May 26, 2021.
Untill when can I market my MDD Medical Devices?
Devices with a valid MDD certificate may be marketed or put into service until the following dates:
- December 31, 2027, for all class III devices and class IIb implantable devices (excluding specific items)
- December 31, 2028, for class IIb devices (except those mentioned above), class IIa devices, and class I devices in sterile condition or with a measuring function
A transition period until May 26, 2026, is now available for class III custom-made implantable devices, providing them with more time to obtain certificates from a notified body.
What are the conditions to make use of the extended transition period?
However, in order to make use of the extended transition period, manufacturers must comply with specific conditions:
- An application must be lodged for the MDR conformity assessment and a MDR QMS must be in place by May 26th, 2024.
- By September 26th, 2024 a written agreement with an Notified Body must be in place.
- Devices must continu to comply with previously applicable legislation, such as the MDD or AIMDD.
- No significant changes may be made to the design or intended purpose.
- The devices may not present any unacceptable risk to health or safety.
Once you have secured the Notified Body agreement by September 26, 2024, Class III and Class IIb implantable devices are granted until December 31, 2027, to conclude the conformity assessment, signifying the end of the transition period. For Class IIb, Class IIa, and Class I sterile/measuring devices, necessitating Notified Body involvement for the first time under MDR, this deadline is extended to December 31, 2028.
Questions? We are happy to discuss your specific case.
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Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.