EU Q&A on Amendments to MDR/IVDR

 

In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745 and (EU) 2017/746.

The EU Q&A document provides further clarity to the MDR/IVDR amendment, which aims to maintain public health protection, patient safety, prevent medical device shortages, and preserve existing quality and safety standards.

This amending regulation extends the timeline for manufacturers and notified bodies to complete conformity assessments in line with the MDR and removes the ‘sell-off’ date in the MDR and IVDR to prevent unnecessary disposal of safe devices. The document’s responses consider the amendment’s objectives and seek to optimize the extended MDR transitional period.

Part A – Scope of the extension of the MDR transitional period

 

Which devices can benefit from the extended transitional period?

• Only ‘legacy devices’ can benefit from the extended transitional period, which includes class I devices under Directive 93/42/EEC (MDD) and devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.

Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?

• Yes, provided their MDD/AIMDD certificates have not been withdrawn by the notified body. ‘Legacy devices’ and corresponding MDR compliant devices 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. If they do not lodge an application for conformity assessment by 26 May 2024, the transitional period will end on that date.

Which classification rules apply to determine whether the extended transitional period ends on 31 December 2027 or on 31 December 2028?

• The classification rules laid down in Annex VIII to the MDR apply to determine the end date of the transitional period based on the device’s risk class.

Does the extended transitional period also apply to custom-made devices?

• A specific transitional period for class III custom-made implantable devices has been introduced by the new Article 120(3f) MDR, allowing them to be placed on the market without the relevant certificate until 26 May 2026, provided certain conditions are met.

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?

• The device benefits from the full transitional period until 31 December 2027 or 31 December 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled. The certificate is deemed to be valid until the end of the applicable transitional period, unless it is withdrawn.

Part B – Evidence of extended transitional period

 

How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?

• The EU Q&A document clarifies that the amendments to MDR/IVDR and the extension to the transitional period and the certificate’s validity is automatic by law, provided certain conditions are met. Manufacturers can demonstrate the validity of the certificate to third parties through different means, including:
• A self-declaration confirming that the conditions for the extension are fulfilled and stating the end date of the transition period, which could be based on a harmonized template.
• 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. The confirmation should clearly identify the devices and certificates covered by the extension and could be based on a harmonized template issued without extra costs.
• Competent authorities can issue certificates of free sale for the duration of the extended certificate validity.
• The European Commission will update its factsheets to explain the functioning of the extended transition period for competent authorities in non-EU/EEA countries, healthcare professionals, healthcare institutions, and the procurement ecosystem.

Part C – Conditions to be fulfilled to benefit from the extended MDR transition period

 

What are the necessary elements of a formal application lodged by the manufacturer?

• The application should include the elements listed in the relevant conformity assessment as referred to in Annexes IX to XI to the MDR, excluding documentation not needed for the conclusion of the written agreement. The application must clearly identify the manufacturer and the devices covered by the application. The manufacturer should provide a timeline for possible submission of the individual technical documentation and any other relevant information.

What are the necessary elements of a written agreement between the manufacturer and the notified body?

• The written agreement should be based on the formal application lodged by the manufacturer and include a schedule for the submission of relevant documentation, such as the full technical documentation for all devices covered by the application.

What is the meaning of “device intended to substitute that device”?

• A device intended to substitute the legacy device will usually differ from the legacy device due to significant changes in its design or intended purpose. The manufacturer is responsible for determining the substitute device and explaining the link to the substituted legacy device.

Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?

• Manufacturers must draw up the documentation on its QMS, which needs to be part of the application for conformity assessment

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. 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.

Part D – Appropriate surveillance to be performed by notified bodies

 

What are the necessary elements of the arrangement for the transfer of the surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?

• The arrangement should follow the same principles outlined in Article 58(1) MDR, including the transfer of relevant documentation and addressing the possibility of the MDR notified body to suspend or withdraw a certificate issued by the MDD/AIMDD notified body, where duly justified.

What does the limitation ‘where practicable’ imply?

• It takes into account cases where the notified body that issued the relevant certificate under the MDD/AIMDD might be unable to sign the contract, e.g., due to termination of business. A written agreement between the manufacturer and the MDR notified body is still required.

Which notified body is responsible for carrying out the appropriate surveillance when a written agreement in accordance with Article 120(3c), point e, MDR is signed between the manufacturer and a notified body designated under the MDR?

• The notified body that issued the relevant certificate under the MDD/AIMDD continues to be responsible for the appropriate surveillance until 26 September 2024, after which the notified body that signed the agreement will become responsible for the appropriate surveillance.

In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implications on the labeling concerning the notified body’s identification number?

• Legacy devices can continue to be placed on the market and made available without changes to the labeling, including CE marking, indicating the number of the notified body that issued the certificate under the Directive. However, the manufacturer may decide to modify the labeling of legacy devices indicating the number of the notified body to which a formal application under the MDR has been lodged, if practically feasible.

Is the NB, which issued the certificate in accordance with Article 120(3b) of MDR, legally obliged to continue to carry out the surveillance of the products concerned until the end of the new transitional period or until the manufacturer has transferred this surveillance obligation to an MDR NB? May this NB deny the manufacturer the use of its NB number?

• The previous notified body must continue the surveillance until 26 September 2024 at the latest. Unless otherwise specified in the tripartite agreement, the use of the number of the notified body that issued the certificate must not be denied until the end of the transition period.

Part E – Deletion of the ‘sell-off’ date

 

Which devices will benefit from the removal of the ‘sell-off’ date?

• Medical devices that have been placed on the market prior to 26 May 2021 in accordance with the MDD/AIMDD or after 26 May 2021 during the transitional period provided for in Article 120 MDR (i.e. until 31 December 2027 or 31 December 2028, as applicable) will benefit from the removal of the ‘sell-off’ date. They may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.
• Similarly, in vitro diagnostic medical devices that have been placed on the market prior to 26 May 2022 in accordance with the IVDD or after 26 May 2022 during the transitional period provided for in Article 110 IVDR (i.e. until 26 May 2025, 26 May 2026 or 26 May 2027, as applicable) will also benefit from the removal of the ‘sell-off’ date. These IVD devices may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.

Please note this article is intended as a summary, to access the full Q&A document, please consult the original source provided by the commission.