引言 - MDR/IVDR修訂的目的
通過第2023/607號（EU）法規(guī)對MDR和IVDR進行的修訂，旨在確保在不降低當前品質(zhì)和安全性要求的前提下，高水平地保護公眾健康，包括保證患者安全以及避免醫(yī)療服務(wù)平穩(wěn)運行所需的醫(yī)療器械出現(xiàn)短缺。出于這個目的，給予了制造商和公告機構(gòu)更充足的時間，來根據(jù)MDR進行相關(guān)器械（其證書或符合性聲明根據(jù)90/385/EEC指令或93/42/EEC指令簽發(fā)或出具）的符合性評估。此外，從MDR和IVDR中刪去停售日期，旨在防止對安全器械進行不必要的處置。
在考慮到法規(guī)修訂所追求的目標的情況下制定了以下問題的回答，目的是充分利用MDR過渡期延長帶來的額外時間。
第A部分 - MDR過渡期延長的范圍
1.哪些器械將會從過渡期延長中受益？
只有“遺留器械”可以從延長的過渡期中受益。根據(jù)MDCG 2021-25，“遺留器械”應(yīng)被理解為根據(jù)MDR的過渡條款，在MDR的施行日期（即2021年5月26日）之后在滿足某些條件的情況下投放市場的器械。這些器械可以是：
根據(jù)93/42/EEC指令（MDD）屬于I類器械（不需要公告機構(gòu)的參與），其EC符合性聲明在2021年5月26日之前編制完成，并且根據(jù)MDR的符合性評估程序需要公告機構(gòu)的參與；
在2021年5月26日之前根據(jù)90/385/EEC指令（AIMDD）或93/42/EEC指令（MDD）簽發(fā)了有效EC證書的器械。
只有在滿足MDR第120條第3c款規(guī)定的條件時，過渡期方可延長至2024年5月26日以后。對于相關(guān)證書在2023年3月20日之前到期的器械，還需要滿足MDR第120條第2款第2段第（a）點或第（b）點規(guī)定的條件（見下文第C部分）。
2.已根據(jù)MDR認證的器械能否從過渡期延長中受益？
能，只要MDD/AIMDD證書未被公告機構(gòu)撤銷。如果制造商不再滿足相關(guān)的法規(guī)要求，或者在不應(yīng)該簽發(fā)證書的情況下，公告機構(gòu)可以撤銷證書，同時應(yīng)考慮到比例原則。器械的MDR認證本身不是公告機構(gòu)撤銷MDD/AIMDD證書的理由。
這意味著“遺留器械”和對應(yīng)的符合MDR的器械可以同時投放市場，直至相關(guān)過渡期結(jié)束。
3.對于“遺留器械”，如果制造商不愿意依照MDR提出認證申請呢？
制造商沒有義務(wù)依照MDR為其“遺留器械”提出認證申請。不過，如果其器械證書的有效期截止日在2023年3月20日和2024年5月26日之間，只要滿足第120條第3c款第（a）~（c）點規(guī)定的條件，過渡期就可以延長至2024年5月26日。如果制造商沒有在2024年5月26日之前提出符合性評估申請，過渡期將于2024年5月26日結(jié)束。
4.應(yīng)該基于哪些分類規(guī)則來判斷延長后的過渡期是在2027年12月31日還是2028年12月31日結(jié)束？
在MDR第120條第3a款（根據(jù)器械的風險等級規(guī)定了新的過渡期）項下，MDR附錄VIII規(guī)定的分類規(guī)則適用。在某些情況下，如果MDR的分類規(guī)則導(dǎo)致不同的風險等級，證書上顯示的器械風險等級可能與決定過渡期結(jié)束日期的風險等級不同。
但是，如果在過渡期內(nèi)需要根據(jù)器械的風險等級來確定適用的MDR要求（如與定期安全性更新報告（PSUR）有關(guān)），則器械的等級是根據(jù)MDD分類規(guī)則確定的等級（見MDCG 2021-25）。
5.過渡期延長是否也適用于定制器械？
MDR第120條第3f款為III類定制植入性器械引入了特定的過渡期。雖然所有其他的定制器械在其制造商按照MDR附錄XIII起草聲明后可以投放市場，但III類定制植入性器械的符合性評估需要公告機構(gòu)的參與。
根據(jù)新的過渡條款，III類定制植入性器械可以在沒有相關(guān)證書的情況下投放市場至2026年5月26日，但制造商必須在2024年5月26日之前向公告機構(gòu)提出符合性評估的申請，并在2024年9月26日之前與該公告機構(gòu)簽署書面協(xié)議。
6.如果證書在2023年3月20日之前已經(jīng)過期，而主管當局已根據(jù)MDR第59條認可了相關(guān)器械可與適用的符合性評估程序相背離（作為適用的符合性評估程序的例外），或已根據(jù)MDR第97條要求制造商執(zhí)行適用的符合性評估程序，那么過渡期有多長？
在第2023/607號（EU）法規(guī)生效前（即2023年3月20日前）已經(jīng)過期的證書，僅在以下情況下才被視為有效：
在證書到期日之前，制造商和公告機構(gòu)已針對到期證書涵蓋的器械或旨在替代該器械的器械進行符合性評估的事宜簽署了書面協(xié)議；
或成員國主管當局已根據(jù)MDR第 59 條第 1 款認可了相關(guān)器械可與適用的符合性評估程序相背離（作為適用的符合性評估程序的例外） ，或已根據(jù)MDR第 97 條第 1 款要求制造商在規(guī)定期限內(nèi)執(zhí)行適用的符合性評估程序（見MDR第120條第2款第2段）。
即使成員國對相關(guān)器械與適用的符合性評估程序相背離的認可是有時間限制的，或者制造商已被要求在規(guī)定的時間內(nèi)執(zhí)行符合性評估程序，只要滿足MDR第120條第3c款規(guī)定的條件，相關(guān)器械就可以從整個過渡期中受益，直至2027年12月31日或2028年12月31日（如適用）。相關(guān)證書被視為有效，直至適用的過渡期結(jié)束，證書被撤銷的情況除外。
第B部分 – 過渡期延長的證據(jù)
7.制造商如何證明其遺留器械可從過渡期延長中受益？
只要滿足了MDR第120條第3c款規(guī)定的條件，過渡期的延長和證書有效期的相應(yīng)延長是按照法規(guī)自動完成的。對于相關(guān)證書在2023年3月20日之前到期的器械，還需要滿足MDR第120條第2款第2段第（a）點或第（b）點規(guī)定的條件（見下文第C部分）。
根據(jù)MDCG指南2020-3，在過渡期內(nèi)，公告機構(gòu)不能簽發(fā)新的MDD/AIMDD證書。但是，公告機構(gòu)可以提供書面確認，糾正或補充現(xiàn)有證書上的信息。
制造商可能需要向第三方證明證書的有效性（例如，為了進入第三國市場或在采購過程中投標）。為此，制造商應(yīng)能通過不同的方式來證明其器械在過渡期延長所覆蓋的范圍內(nèi)以及證書有效。
制造商應(yīng)該能夠提供一份自我聲明，確認滿足延期的條件，并說明過渡期的結(jié)束日期。自我聲明可以基于統(tǒng)一的模板。自我聲明應(yīng)明確指出延期所涉及的器械和相關(guān)證書。額外的證據(jù)可以借助公告機構(gòu)發(fā)出的“確認函”，說明公告機構(gòu)已收到制造商的符合性評估申請并與制造商簽訂書面協(xié)議。確認函應(yīng)明確指出延期和相關(guān)證書所涵蓋的器械。確認函可以基于統(tǒng)一的模板，原則上無需額外的費用便可簽發(fā)。
成員國主管當局應(yīng)能在延長的證書有效期內(nèi)簽發(fā)自由銷售證書。
歐盟委員會將為非歐盟/歐洲經(jīng)濟區(qū)國家的主管當局、醫(yī)護專業(yè)人員和醫(yī)療機構(gòu)以及采購生態(tài)圈更新其情況說明書（Factsheet），解釋過渡期延長的運作情況。
第C部分 - 從MDR過渡期延長中受益需滿足的條件
8.制造商提交正式申請所需的要素是什么？
根據(jù)MDR第120條第3c款第（e）點，制造商或授權(quán)代表必須在2024年5月26日之前按照MDR附錄VII第4.3節(jié)第1段的規(guī)定向公告機構(gòu)提交正式的符合性評估申請。制造商和公告機構(gòu)必須在2024年9月26日之前按照MDR附錄VII第4.3節(jié)第2段簽署書面協(xié)議，以享受延長的過渡期。
MDR第120條第3c款第（e）點并未提及根據(jù)MDR附錄VII第4.3節(jié)第3段對申請進行審查。這意味著，在簽署書面協(xié)議之前，不需要公告機構(gòu)對申請進行全面審查。
原則上，申請應(yīng)包括MDR附錄IX ~XI中提及的相關(guān)符合性評估中所列的內(nèi)容。然而，需要考慮的是，在簽訂書面協(xié)議之前不需要對申請進行全面審查，而且從申請的最后期限（2024年5月）到制造商和公告機構(gòu)實際執(zhí)行符合性評估活動之間的時間跨度可能很長（最晚到2028年）。因此，公告機構(gòu)在與制造商簽訂書面協(xié)議時不需要的文件以及制造商在實際符合性評估前可能更新的文件不需要與申請一起提交。
這意味著，申請時不需要提交其所涵蓋的需要接受技術(shù)文件評審的每個器械的技術(shù)文件。但是，申請時必須清楚地標識制造商和申請所涵蓋的器械（例如，通過包含計劃轉(zhuǎn)移到MDR的器械列表以及（在適用情況下）旨在替代“遺留器械”的器械的相關(guān)信息）。與申請一起提交的信息需足以讓公告機構(gòu)核實產(chǎn)品作為器械的資格、產(chǎn)品各自的分類以及所選擇的符合性評估程序。在提交申請時，制造商應(yīng)提供可能提交單個技術(shù)文件和任何其他相關(guān)信息的時間表。公告機構(gòu)和制造商應(yīng)就在適當時間提交符合性評估活動所需的相關(guān)技術(shù)文件或其他信息的計劃達成一致。
由于制造商最遲需要在2024年5月26日之前符合MDR的質(zhì)量管理體系（QMS）要求，因此對QMS的符合性評估申請應(yīng)包括制造商的QMS文件。
如果制造商提交旨在替代遺留器械的器械的符合性評估申請，制造商不僅需要明確替代器械，還需要明確擬被替代的遺留器械，替代器械的技術(shù)文件可以在后面的階段提交。
9.制造商和公告機構(gòu)之間的書面協(xié)議所需包含的要素有哪些？
根據(jù)MDR第120條第3c款第（e）點，公告機構(gòu)和制造商必須在2024年9月26日之前簽署符合MDR附錄VII第4.3節(jié)第2段相關(guān)要求的書面協(xié)議。MDR附錄VII第4.3節(jié)第2段的要求尚未修訂。
制造商或授權(quán)代表提交的正式申請（見本文件第8個問題）應(yīng)作為簽署書面協(xié)議的基礎(chǔ)。書面協(xié)議應(yīng)包括提交申請時未提供的相關(guān)文件（如正式申請所涵蓋的所有器械的完整技術(shù)文件）的提交時間表。
為了促進公告機構(gòu)之間的一致性，NBCG-Med（公告機構(gòu)協(xié)調(diào)小組）與MDCG工作組公告機構(gòu)監(jiān)督分組（NBO）達成一致，可能會對MDR第120條第3c款第（e）點中提及的公告機構(gòu)與制造商之間簽署的書面協(xié)議中應(yīng)包括的標準要素進行額外的澄清。
英文原文
Extension of the MDR Transitional Period and Removal of the “Sell Off” Periods
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Disclaimer: This Q&A document is intended to facilitate the application of Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. This document has not been formally endorsed by the European Commission and is without prejudice to any interpretation of the relevant provisions by the Court of Justice of the European Union or national courts. The information in this Q&A document is of a general nature and not intended to address specific circumstances of any particular case; the document does not intend to provide professional or legal advice. The information is not necessarily comprehensive nor complete. If needed, this document will be updated in order to address additional questions that may arise.
Introduction – Objectives of the MDR/IVDR amendment
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.
PART A – SCOPE OF THE EXTENSION OF THE MDR TRANSITIONAL PERIOD
1. Which devices can benefit from the extended transitional period?
Only ‘legacy devices’ can benefit from the extended transitional period. In line with MDCG 2021-25 ‘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 below part C).
2. 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.
3. 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.
4. 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).
5. 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.
6. 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 time, 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
7. 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 below part C).
In line with MDCG guidance 2020-3, 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.
PART C - CONDITIONS TO BE FULFILLED TO BENEFIT FROM THE EXTENDED MDR TRANSITION PERIOD
8. 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 MDR 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.
9. 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 (see question no 8 of this document) 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
原文鏈接：https://health.ec.europa.eu/latest-updates/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en
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