The European Medical Device Regulation (MDR) has brought harmonization for many medical device manufacturers. However, the transition period for legacy devices and the MDR harmonization process can be challenging for many manufacturers. Fortunately, the extended transition period to MDR offered under the MDR offers legacy device manufacturers a chance to catch their breath. In this article, we will explore the scope of the extension of the MDR transition period and how legacy devices can take advantage of it.
Companies that have been operating in the field of medical devices for many years and have completed the MDR transition process are already aware of the difficulty and importance of the transition. However, for some devices, especially older devices, there are “Extended Transition Period” benefits that offer additional time and ease of transition.
Who Can Benefit from the Extended MDR Transition Period?
1. Old Devices: Devices for which an EC declaration of conformity was issued before 26 May 2021, such as Class I devices, and for which the conformity assessment procedure under the MDR requires the participation of a notified body.
2. Devices with Valid Certificates: Devices with a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or MDD before 26 May 2021.
Notice for After the Transition Period:
The transition period to the extended MDR will be valid if the conditions set out in Article 120(3c) of the MDR are fulfilled. In addition, for devices whose certificates expired before March 20, 2023, the conditions set out in the second subparagraph of Article 120(2), (a) or (b) will also need to be met.
Can MDR Compliant Devices Benefit from the MDR Transition Period?
Yes, devices certified in compliance with the MDR can benefit from the extended MDR transition period. An important condition to benefit from this advantage is that the MDD/AIMDD certificates have not been withdrawn by the notified body.
Which classification rules apply to determine whether the extended transition period ends on December 31, 2027 or December 31, 2028?
The end date of the extended transition period may be December 31, 2027 or December 31, 2028, depending on the risk class of the device. However, to determine the applicable MDR requirements, the class of the device is determined according to the MDD classification rules.
How can the manufacturer demonstrate that its legacy device benefits from the extension of the MDR transition period?
The manufacturer can take the following steps to demonstrate that it benefits from the extension of the transition period to the MDR:
1. Submit a self-declaration confirming that the conditions for the extension have been fulfilled, indicating that the transition period has been extended.
2. This self-declaration should clearly identify the devices and relevant certificates covered by the extension, based on a harmonized template.
3. The manufacturer may also demonstrate that it has applied for conformity assessment and signed a written agreement with a notified body by other means, such as a copy of the relevant documents.
4. Competent authorities may issue free sale certificates during the extended certificate validity period.
5. The European Commission will update factsheets for competent authorities, healthcare professionals and healthcare institutions and the supply ecosystem in non-EU/EEA countries, explaining the functioning of the transition period to the extended MDR.
What are the required elements of a formal application by the manufacturer?
To benefit from the extended transitional period, the manufacturer or authorized representative must submit a formal application for conformity assessment to Annex VII MDR Section 4.3 no later than 26 May 2024 and sign a written agreement no later than 26 September 2024. The application can be submitted without the need for a full review of the actual conformity assessment activities. The application must include a list of the devices to be conformity assessed and the relevant technical documentation. The application also requires the identification of the device to be substituted, but the technical documentation of the substitute device can be submitted at a later stage. The manufacturer must also submit documentation of its QMS with the application to comply with the quality management system requirements of the MDR.
– What happens if the application is withdrawn or the written agreement is terminated?
If the application is withdrawn or the written agreement is terminated, the conditions set out in Article 120(3c), subparagraph (e) of the MDR are no longer met after the relevant deadlines and the transition period to the extended MDR ends. However, if the manufacturer terminates the written agreement and concludes an agreement with another notified body at the same time and the conditions of Article 120(3c), subparagraph (e) are still met, the transition period to MDR shall continue, provided that the other conditions are also met.
-What is the impact of manufacturer-related changes during the transition period to MDR?
Administrative changes related to the manufacturer during the transition period (e.g. changes of name, address or legal form) are generally not considered a change in design or intended use and do not affect the extended MDR transition period. Such administrative changes are possible and do not carry any additional requirements to maintain the MDR transition period.
What are the necessary elements of a written agreement between the manufacturer and the notified body?
The following elements are required to sign a written agreement between the manufacturer and the notified body:
Formal Application: The formal application, which will form the basis of the written agreement, must be submitted for conformity assessment of the relevant devices.
Technical Documentation Schedule: The agreement should include a possible schedule for the submission of relevant documentation not submitted at the time the application is made.
Consistency and Standards: In order to promote consistency between notified bodies, additional clarifications on standard elements may be provided in the written agreement referred to in Article 120(3c), (e) of the MDR.
The inclusion of these elements in the written agreement is an important step to benefit from the extended MDR transition period and ensures that the relevant process proceeds in an orderly and efficient manner.
What evidence does the manufacturer have to provide that it has implemented a QMS in accordance with the MDR?
The manufacturer must provide the following evidence that it has established a Quality Management System (QMS) in accordance with the MDR:
-QMS documentation
-QMS policies and procedures
-Part of the conformity assessment application
-Market surveillance and audit plans
-Record keeping procedures
The notified body shall assess the manufacturer’s QMS as part of its conformity assessment activities.
Do legacy devices have to comply with UDI requirements during the transition period to the extended MDR?
Legacy devices do not have to comply with MDR UDI (Unique Device Identifiers) requirements during the transition period to the extended MDR. However, the legacy device manufacturer must have implemented an MDR compliant Quality Management System (QMS). According to Article 10(9), subparagraph (h) of the MDR, UDI assignment should only be made where it is actually necessary for the devices concerned.
SECTION E - DELETING THE 'SALE' DATE
Which devices will benefit from the removal of the ‘sale’ date?
Devices that were placed on the market as eligible under the MDR before May 26, 2021 or the IVDR before May 26, 2022, and during the subsequent transition period to the MDR (December 31, 2027 or December 31, 2028 for the MDR, May 26, 2025, May 26, 2026 or May 26, 2027 for the IVDR) will benefit from the removal of the “sale” date.
The MDR transition period presents an important opportunity for manufacturers of legacy devices. Devices manufactured under MDD/AIMDD can, under certain conditions, remain on the market in parallel with MDR-compliant devices. This gives manufacturers more time and flexibility and makes the compliance process more manageable. Manufacturers wishing to benefit from the extended MDR transition period should contact notified bodies and make efforts to meet the necessary requirements.
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