Introductory Remarks
Continuing our examination of the MDR/IVDR transition period, we delve into the transition period’s subtler points. In this section, we examine the conditions manufacturers must meet in order to benefit from the extended transition, as well as the evidence required to support this procedure. In addition, we explicate the nuances of transitioning surveillance from the notified body that issued MDD/AIMDD certificates to a new MDR-notified body. Let’s untangle the complexities together.
Certificate Expiration and the Extended Transition Period
Important clarification: A certificate that has expired will not be deemed valid, and the extended transitional period specified in Article 120(3a) of the MDR will not apply. This emphasizes the importance of adhering to the amendment’s specified deadlines and requirements.
Exemption and the CE Marking
Even if they were not required to bear CE marking, devices that have been granted an exemption in accordance with Article 59 of the MDR can still benefit from the transitional period. This emphasizes the adaptability and flexibility of the regulations to specific situations.
Indications of a Protracted Transitional Period
Manufacturers must show that their legacy devices qualify for the transitional period extension. If the conditions specified in Article 120(3c) of the MDR are met, the extension occurs automatically by law. During the transitional period, notified bodies cannot issue new MDD/AIMDD certificates, but they can provide written confirmations that correct or supplement existing certificates.
Manufacturers must be outfitted with the means to show the extended validity of the transitional period to third parties, such as when accessing non-EU/EEA markets or participating in procurement processes. They may use a self-declaration referencing standardized templates to confirm compliance with extension conditions. A “confirmation letter” from the notified body indicating receipt of the manufacturer’s application and the signed agreement is another potential piece of evidence.
Application from the Manufacturer and Written Agreement
By May 26, 2024, the manufacturer or their allowed representative must apply for conformity assessment. Under Section 4.3 of Annex VII MDR, a written agreement between the manufacturer and the notified body must be executed by 26 September 2024. Notably, a thorough examination of the application is not required prior to signing the written agreement.
The application should define the essential components of the applicable conformity evaluation, while the agreement clarifies the submission schedule for additional documentation. This documentation is not required for the initial application and can be revised prior to the conformity evaluation, given the extended timeline.
Changes to the Notified Body and the Manufacturer
Generally, organizational (administrative) changes within a manufacturer will not affect the transitional period. However, specific conditions must be fulfilled if a manufacturer intends to market devices certified under MDD/AIMDD by another manufacturer under the MDR.
Device Replacement and QMS Compliance
The phrase “device designed to replace that device” alludes to a device intended to replace an existing device. The transitional period for the legacy device applies only to the legacy device, not its replacement, which must endure a full MDR conformity assessment.
By May 26, 2024, manufacturers must provide evidence of a Quality Management System (QMS) compliant with Article 10(9) of the MDR. According to MDCG 2019-5, UDI requirements do not apply to legacy devices during the extended transitional period.
Replace Device with Surveillance
A crucial realization emerges: for a replacement device to enter the market, it must endure a comprehensive MDR conformity assessment. The extended transitional period outlined in Article 120(3a) and (3b) of the MDR pertains only to the ‘legacy device’ that the substitute device replaces. After MDR certification of the replacement device, both the ‘legacy device’ and the replacement device may coexist on the market until the end of the transitional period.
Quality Management System (QMS) and Outdated Equipment
Article 120(3c)(d) of the MDR requires manufacturers to implement a QMS compliant with the MDR by May 26, 2024. The documentation for this QMS is included in the application for conformity assessment. During the extended transitional period, as specified in MDCG 2019-5, however, legacy devices are not required to comply with UDI requirements. This holds true despite the requirement for an MDR-compliant QMS.
Existing Applications and Contracts Continued
Prior to March 20, 2023, manufacturers who have submitted an application for conformity assessment and signed a written agreement with a notified body are exempt from resubmitting applications and signing new agreements. Existing petitions and agreements are considered valid and compliant with MDR Article 120(3c)(e) requirements.
Transfer of Surveillance: Principal Components
The transfer of appropriate surveillance from the MDD/AIMDD certificate-issuing body to the MDR-issuing body requires well-structured agreements. The transfer adheres to the principles outlined in Article 58(1) of the MDR, which includes the migration of pertinent documentation. The transfer procedure is outlined in the agreement between the manufacturers, the MDR notified body, and the MDD/AIMDD notified body. This includes provisions for the potential suspension or revocation of certificates and outlines the responsibilities of the MDR-notified body.
Labeling and Surveillance to Continue
The previous notified body’s surveillance responsibilities under the MDD/AIMDD will continue until September 26, 2024. The use of the notified body’s identification number on labels may not be denied until that date. Article 120(3e) of the MDR limits the notified body’s involvement to appropriate surveillance activities.
The change of the Notified Body
In the scenario where a manufacturer withdraws its conformity assessment application or terminates the written agreement with the notified body after the specified deadlines, the conditions in Article 120(3c), point (e) of the MDR are no longer met, resulting in the discontinuation of the transitional period. However, if a manufacturer or the notified body terminates the written agreement and promptly establishes a new agreement with another notified body, transferring the application, the conditions are considered maintained, allowing the transitional period to persist, provided all other prerequisites are satisfied. This shift in notified body should be documented through an agreement involving the manufacturer, the incoming notified body, and the outgoing notified body, modeled on Article 58 of the MDR. Such a transition might occur due to factors like capacity constraints or new designations. After this change, the manufacturer must update the documentation validating the legacy device’s eligibility for the extended transitional period, including self-declarations and the notified body’s confirmation letter. Conversely, if a manufacturer alters the notified body because of a well-founded refusal based on non-compliance with MDR requirements, the transitional period should not continue beyond the specified deadlines.
Delete the ‘Sell-Off’ Date
The ‘sell-off’ date, which outlined the cutoff for devices posted on the market under the Directives, is eliminated. This modification allows devices placed on the market prior to the specified dates and during the transitional periods to remain on the market indefinitely without time restrictions and without affecting prospective shelf-life or expiration dates.
The Conclusion
The extended transitional period stipulated by the MDR/IVDR amendment causes a thorough comprehension of the relevant conditions, evidence, and nuances. Manufacturers must ensure their devices meet the extension’s criteria, provide supporting documentation, and manage conformance while embracing the amendment’s objectives of patient safety, public health protection, and seamless healthcare service delivery.
In the grand tapestry of the MDR amendment, this section also delves into the transfer of surveillance responsibilities, the elimination of the ‘sell-off’ date, and nuances pertaining to devices’ ongoing market access. It highlights the intricate interplay of regulations and their practical implications, as manufacturers navigate an ever-changing environment with diligence and adaptability.
