EXTENSION OF THE MDR QA
Introduction – Objectives of the MDR/IVDR amendment REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.
The answers to the questions set out below have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period and published by the European Commission. Our experts have selected some important questions for Manufacturers.
Which devices can benefit from the extended transitional period?
Only ‘legacy devices’ can benefit from the extended transitional period. In line with MDCG 2021- 2522 ‘legacy devices’ should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled. Those devices can be:
- devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
- devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.
The extension of the transitional period beyond 26 May 2024 only applies if the conditions laid down in Article 120(3c) MDR are fulfilled. In case of devices for which the relevant certificate has expired before 20 March 2023, also the conditions laid in the second subparagraph of Article 120(2), points (a) or (b), MDR need to be fulfilled (see here).
Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?
Yes, provided the MDD/AIMDD certificates have not been withdrawn by the notified body. A notified body may withdraw a certificate if the relevant legal requirements are no longer met by the manufacturer or where a certificate should not have been issued, taking account of the principle of proportionality. The MDR certification of the device as such is not a reason for the notified body to withdraw a MDD/AIMDD certificate.
That means that a ‘legacy device’ and the corresponding MDR compliant device can be placed on the market in parallel until the end of the relevant transitional period.
What about ‘legacy devices’ for which the manufacturer does not wish to apply under the MDR?
Manufacturers are not obliged to apply for their ‘legacy devices’ under the MDR. Nonetheless, if their device is covered by a certificate that expires after 20 March 2023 and before 26 May 2024, they benefit from the extension of the transitional period until 26 May 2024, provided the conditions set out in Article 120(3c), points (a) to (c), are fulfilled. If the manufacturer does not lodge an application for conformity assessment by 26 May 2024, the transition period will end on 26 May 2024.
Which classification rules apply to determine whether the extended transitional period ends on 31 December 2027 or on 31 December 2028?
For the purpose of Article 120(3a) MDR, which provides for the new transitional periods depending on the device’s risk class, the classification rules laid down in Annex VIII to the MDR apply. In certain cases, where the classification rules of the MDR result in a different risk class, the device’s risk class indicated on the certificate may differ from the risk class that determines the end date of the transitional period.
However, where during the transitional period the risk class of a device is needed to determine applicable MDR requirements (e.g. in relation to PSUR), the class of the device is the one established in accordance with the MDD classification rules (see MDCG 2021-25).
Does the extended transitional period also apply to custom-made devices?
The new Article 120(3f) MDR has introduced a specific transitional period for class III custom- made implantable devices. While all other custom-made devices can be placed on the market after their manufacturer has drawn up a statement in accordance with Annex XIII to the MDR, the conformity assessment of class III custom-made implantable devices requires the involvement of a notified body.
Pursuant to the new transitional provision, class III custom-made implantable devices can be placed on the market without the relevant certificate until 26 May 2026, provided the manufacturer has lodged an application with a notified body for conformity assessment no later than 26 May 2024 and signed a written agreement with that notified body no later than 26 September 2024.
If a certificate has expired before 20 March 2023 and a competent authority has granted a derogation in accordance with Article 59 MDR or has applied Article 97 MDR, how long is the transitional period?
Certificates that have expired before the entry into force of the amending Regulation 2023/607 (i.e. 20 March 2023) shall only be considered valid if
- either before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device,
- or a national competent authority has granted a derogation in accordance with Article 59(1) MDR or has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure within a specified period of time (see the second subparagraph of Article 120(2) MDR).
Even if the national derogation is limited in time or the manufacturer has been required to carry out the conformity assessment procedure within a given period of time3, the device benefits from
How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?
The extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law, provided the conditions laid down in Article 120(3c) MDR are fulfilled. In case of devices for which the relevant certificate has expired before 20 March 2023, also the conditions laid in the second subparagraph of Article 120(2), points (a) or (b), MDR need to be fulfilled (see here).
In line with MDCG guidance 2020-344, during the transitional period, notified bodies cannot issue new MDD/AIMDD certificates. However, they can provide written confirmation correcting or complementing information on an existing certificate.
It is acknowledged that the manufacturer may need to demonstrate validity of the certificate to third parties, for example to access the market in third countries or to submit tenders in procurement procedures. For that purpose, manufacturers should have access to different means of demonstrating that their device is covered by the extended transitional period and a valid certificate.
The manufacturer should be able to provide a self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned. Additional evidence could be provided by a ‘confirmation letter’ issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonised template and be issued, in principle, without extra costs.
Competent authorities should be able to issue certificates of free sale for the duration of the extended certificate validity.
The European Commission will update its factsheets for competent authorities in non-EU/EEA countries, for healthcare professionals and healthcare institutions and for the procurement ecosystem, explaining the functioning of the extended transition period.
What are the necessary elements of a formal application lodged by the manufacturer?
Pursuant to Article 120(3c), point (e), MDR the manufacturer or the authorised representative must lodge a formal application for conformity assessment in accordance with Section 4.3, first subparagraph, of Annex VII MDR no later than 26 May 2024. Manufacturer and notified body must sign a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII MDR no later than 26 September 2024 to benefit from the extended transitional period. Article 120(3c), point (e), MDR does not refer to a review of applications in accordance with Section 4.3, third subparagraph, of Annex VII MDR. That means that a full review of the application by the notified body is not required before the signature of the written agreement.
The application should, in principle, include the elements listed in the relevant conformity assessment as referred to in Annexes IX to XI to the MDR. However, it needs to be taken into account that a full review of the application prior to the conclusion of the written agreement is not required and that the time span between the deadline for the application (May 2024) and the actual conformity assessment activities to be performed by manufacturers and notified bodies can be very long (until 2028 at the latest). Therefore, the documentation that the notified body does not need for the conclusion of the written agreement with the manufacturer and that is likely to be updated by the manufacturer before the actual conformity assessment does not need to be submitted with the application.
That means that the application does not need to include, for example, the technical documentation for each device covered by the application and which is subject to technical documentation review. However, the application must clearly identify the manufacturer and the devices covered by the application for example by including the list of devices intended to be transferred to the MDR5 and, where applicable, the device(s) intended to substitute a ‘legacy device’. The information submitted with the application needs to allow the notified body to verify the qualification of the products as devices, their respective classification and the chosen conformity assessment procedure. When lodging the application, the manufacturer should provide a timeline for possible submission of the individual technical documentation and any other relevant information. Notified body and manufacturer should agree on a plan for submission of the relevant technical documentation or other information needed for the conformity assessment activities in due time.
As the manufacturer needs to comply with the quality management system (QMS) requirements of the MDR by 26 May 2024 at the latest, the application for conformity assessment of the QMS should include the documentation on the manufacturer’s QMS.
Where the manufacturer lodges an application for conformity assessment of a device that is intended to substitute a legacy device, the manufacturer does not only need to identify the substitute device but also the legacy device that is intended to be substituted. The technical documentation of the substitute device can be submitted at a later stage.
What are the necessary elements of a written agreement between the manufacturer and the notified body?
Pursuant to Article 120(3c), point (e), MDR, a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII MDR must have been signed between the notified body and the manufacturer no later than 26 September 2024. Requirements laid down in Section 4.3, second subparagraph, of Annex VII MDR have not been amended.
The formal application lodged by the manufacturer or the authorised representative should be the basis for signing the written agreement. The written agreement should include indication about the possible schedule for submission of relevant documentation, such as full technical documentation for all devices covered by the formal application, not provided at the time the application is lodged. With the purpose of promoting consistency among notified bodies, NBCG-Med, in agreement with the MDCG working group Notified Bodies Oversight (NBO), might provide additional clarification on standard elements to be included in the written agreement signed between the notified body and the manufacturer referred to in point (e) of Article 120(3c) MDR.
What is the meaning of “device intended to substitute that device”?
The term “device intended to substitute that device” is used in the second subparagraph of Article 120(2), point (a), in Article 120(3c), point (e), and in the second subparagraph of Article 120(3e) MDR. A device intended to substitute the legacy device will usually (but not necessarily) differ from the legacy device because the manufacturer has made (significant) changes with regard to its design or intended purpose with a view to replacing the legacy device. It is the responsibility of the manufacturer to determine the device that is intended to substitute a legacy device and to explain the link to the substituted legacy device.
It should be noted that the substitute device will need to undergo the full MDR conformity assessment before it can be placed on the market. The transitional period provided for in Article 120(3a) and (3b) MDR only applies to the ‘legacy device’ that is being replaced by the substitute device. Similar to what is stated in question no. 2, after MDR certification of the substitute device, the ‘legacy device’ and the substitute device can be placed on the market in parallel until the end of the relevant transitional period.
Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?
Pursuant to Article 120(3c), point (d), MDR the manufacturer must put in place a QMS in accordance with Article 10(9) MDR no later than 26 May 2024. Manufacturers must draw up the documentation on its QMS, which needs to be part of the application for conformity assessment. Compliance with QMS-related requirements concerning post-market surveillance, market surveillance, vigilance and registration are part of the appropriate surveillance pursuant to Article 120(3e) MDR, while the assessment of the compliance with the MDR of the entire QMS will be done by the notified body as part of its conformity assessment activities.
Do manufacturers, which have lodged an application for conformity assessment and have concluded a written agreement with a notified body before 20 March 2023, have to lodge a new application and/or conclude a new written agreement?
No. Provided the application has not been rejected, applications lodged prior to the entry into force of the amending Regulation 2023/607 (i.e. 20 March 2023) remain valid and are sufficient for fulfilling the condition set out in Article 120(3c), point (e) MDR. No new written agreement needs to be signed either.
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