With the amendment of the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) by Regulation (EU) 2023/607, the world of medical devices is enduring a revolutionary transformation. This amendment should accomplish several important goals, including ensuring a robust level of public health protection, augmenting patient safety, and preventing disruptions in healthcare services caused by a lack of essential medical devices. In this blog post, we will examine the primary goals of the MDR/IVDR amendment and the extended transitional period provided for in Article 120 of the MDR.
Objectives of the Amendment to the MDR/IVDR
The primary objective of the MDR/IVDR amendment is to establish a balance between public health protection and the maintenance of medical device quality and safety standards. This amendment is not intended to compromise safety; rather, it is intended to create a smoother transition for manufacturers and healthcare providers while ensuring that secure devices are not discarded. The primary goals can be summed up as follows:
- Protection of Public Health: The amended regulations emphasize the significance of protecting public health. This includes assuring patient safety and minimizing medical device-related risks. By allowing manufacturers and notified bodies more time to conduct conformity assessments, the amendment aims to maintain high quality standards for medical devices.
- Preventing Deficiencies: The amendment acknowledges the vital role that medical devices play in the delivery of healthcare services. In order to prevent shortages and disruptions, the amendment extends the transitional period, ensuring that all necessary devices are accessible during the transition to the new regulations.
- Maintaining Quality and Safety: The amendment ensures that the extension of the transitional period will not jeopardize the current quality and safety requirements for medical devices. The objective is to facilitate a transition without compromising the standards upon which patients and healthcare providers rely.
- Minimizing Waste: The amendment eliminates the ‘sell-off’ date from the MDR and IVDR, which is a significant change (conditions covered in the second part of this blog series). This modification should prevent the unwarranted disposal of secure medical devices, promoting sustainability and responsible resource management.
Objectives of the Protracted Transitional Period
Article 120 of the MDR’s extended transitional period is a crucial component of the amendment. This period provides manufacturers with additional time to comply with the new regulations, particularly for ‘legacy devices.’ Below, I summarize the most important aspects of this extension’s scope:
Legacy Devices: The extended transitional period pertains only to ‘legacy devices.’ These are devices that satisfy certain criteria and were introduced to the market after the MDR’s applicability date (May 26, 2021). These devices include class I devices under Directive 93/42/EEC (MDD) with an EC declaration of conformity issued prior to May 26, 2021 for which conformity assessment procedure under the MDR requires involvement of a notified body, as well as devices covered by valid EC certificates issued under Directive 90/385/EEC (AIMDD) or the MDD prior to the same date.
Read the official document “EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS.”European Commission
Certified Devices: As long as their MDD/AIMDD certificates have not been revoked by the notified body, devices that have been certified under the MDR are also eligible for the extended transitional period. During the transitional period, this allows manufacturers to continue posting both legacy devices and MDR-compliant devices on the market concurrently.
Manufacturer Option: Although manufacturers are not required to submit legacy devices to the MDR, those with certificates expiring between March 20, 2023 and May 26, 2024 may qualify for the extended transitional period under certain conditions.
Classification Rules: The end date of the extended transitional period is dependent on the risk class of the device, as determined by Annex VIII of the MDR’s classification rules. Sometimes, the risk category on the certificate may differ from the one used to determine the end of the transitional period.
Custom-Made Implantable Devices: The amendment establishes a specific transitional period for custom-made implantable devices of class III. Class III custom-made implantable devices cannot be placed on the market without the involvement of a notified body, whereas other custom-made devices can be marketed with only a statement. The transition period for these devices ends on May 26, 2026, assuming certain conditions are met.
Expired Certificates: If certain conditions are met, including agreements with notified bodies or national competent authorities, certificates that expired prior to March 20, 2023 may be considered valid. Until December 31, 2027 or December 31, 2028, depending on the risk class, the full transitional period applies to these devices.
The MDR/IVDR amendment is motivated by a dedication to the preservation of public health, patient safety, and the efficient operation of healthcare services. The duration and scope of the transitional period are crucial to attaining these objectives. By comprehending the objectives of the amendment and the extended transitional period, manufacturers, notified bodies, and other stakeholders can more effectively navigate the developing landscape of medical device regulations.
In the next part of this blog series (which is the last part), we’ll delve into the details of the extended transitional period, the specific conditions for applying it, and how manufacturers can make the best use of this additional time. Stay tuned for a thorough overview of this essential aspect of the MDR/IVDR amendment process.