引言 - MDR/IVDR修订的目的
通过第2023/607号（EU）法规对MDR和IVDR进行的修订，旨在确保在不降低当前品质和安全性要求的前提下，高水平地保护公众健康，包括保证患者安全以及避免医疗服务平稳运行所需的医疗器械出现短缺。出于这个目的，给予了制造商和公告机构更充足的时间，来根据MDR进行相关器械（其证书或符合性声明根据90/385/EEC指令或93/42/EEC指令签发或出具）的符合性评估。此外，从MDR和IVDR中删去停售日期，旨在防止对安全器械进行不必要的处置。
在考虑到法规修订所追求的目标的情况下制定了以下问题的回答，目的是充分利用MDR过渡期延长带来的额外时间。
第A部分 - MDR过渡期延长的范围
1.哪些器械将会从过渡期延长中受益？
只有“遗留器械”可以从延长的过渡期中受益。根据MDCG 2021-25，“遗留器械”应被理解为根据MDR的过渡条款，在MDR的施行日期（即2021年5月26日）之后在满足某些条件的情况下投放市场的器械。这些器械可以是：
根据93/42/EEC指令（MDD）属于I类器械（不需要公告机构的参与），其EC符合性声明在2021年5月26日之前编制完成，并且根据MDR的符合性评估程序需要公告机构的参与；
在2021年5月26日之前根据90/385/EEC指令（AIMDD）或93/42/EEC指令（MDD）签发了有效EC证书的器械。
只有在满足MDR第120条第3c款规定的条件时，过渡期方可延长至2024年5月26日以后。对于相关证书在2023年3月20日之前到期的器械，还需要满足MDR第120条第2款第2段第（a）点或第（b）点规定的条件（见下文第C部分）。
2.已根据MDR认证的器械能否从过渡期延长中受益？
能，只要MDD/AIMDD证书未被公告机构撤销。如果制造商不再满足相关的法规要求，或者在不应该签发证书的情况下，公告机构可以撤销证书，同时应考虑到比例原则。器械的MDR认证本身不是公告机构撤销MDD/AIMDD证书的理由。
这意味着“遗留器械”和对应的符合MDR的器械可以同时投放市场，直至相关过渡期结束。
3.对于“遗留器械”，如果制造商不愿意依照MDR提出认证申请呢？
制造商没有义务依照MDR为其“遗留器械”提出认证申请。不过，如果其器械证书的有效期截止日在2023年3月20日和2024年5月26日之间，只要满足第120条第3c款第（a）~（c）点规定的条件，过渡期就可以延长至2024年5月26日。如果制造商没有在2024年5月26日之前提出符合性评估申请，过渡期将于2024年5月26日结束。
4.应该基于哪些分类规则来判断延长后的过渡期是在2027年12月31日还是2028年12月31日结束？
在MDR第120条第3a款（根据器械的风险等级规定了新的过渡期）项下，MDR附录VIII规定的分类规则适用。在某些情况下，如果MDR的分类规则导致不同的风险等级，证书上显示的器械风险等级可能与决定过渡期结束日期的风险等级不同。
但是，如果在过渡期内需要根据器械的风险等级来确定适用的MDR要求（如与定期安全性更新报告（PSUR）有关），则器械的等级是根据MDD分类规则确定的等级（见MDCG 2021-25）。
5.过渡期延长是否也适用于定制器械？
MDR第120条第3f款为III类定制植入性器械引入了特定的过渡期。虽然所有其他的定制器械在其制造商按照MDR附录XIII起草声明后可以投放市场，但III类定制植入性器械的符合性评估需要公告机构的参与。
根据新的过渡条款，III类定制植入性器械可以在没有相关证书的情况下投放市场至2026年5月26日，但制造商必须在2024年5月26日之前向公告机构提出符合性评估的申请，并在2024年9月26日之前与该公告机构签署书面协议。
6.如果证书在2023年3月20日之前已经过期，而主管当局已根据MDR第59条认可了相关器械可与适用的符合性评估程序相背离（作为适用的符合性评估程序的例外），或已根据MDR第97条要求制造商执行适用的符合性评估程序，那么过渡期有多长？
在第2023/607号（EU）法规生效前（即2023年3月20日前）已经过期的证书，仅在以下情况下才被视为有效：
在证书到期日之前，制造商和公告机构已针对到期证书涵盖的器械或旨在替代该器械的器械进行符合性评估的事宜签署了书面协议；
或成员国主管当局已根据MDR第 59 条第 1 款认可了相关器械可与适用的符合性评估程序相背离（作为适用的符合性评估程序的例外） ，或已根据MDR第 97 条第 1 款要求制造商在规定期限内执行适用的符合性评估程序（见MDR第120条第2款第2段）。
即使成员国对相关器械与适用的符合性评估程序相背离的认可是有时间限制的，或者制造商已被要求在规定的时间内执行符合性评估程序，只要满足MDR第120条第3c款规定的条件，相关器械就可以从整个过渡期中受益，直至2027年12月31日或2028年12月31日（如适用）。相关证书被视为有效，直至适用的过渡期结束，证书被撤销的情况除外。
第B部分 – 过渡期延长的证据
7.制造商如何证明其遗留器械可从过渡期延长中受益？
只要满足了MDR第120条第3c款规定的条件，过渡期的延长和证书有效期的相应延长是按照法规自动完成的。对于相关证书在2023年3月20日之前到期的器械，还需要满足MDR第120条第2款第2段第（a）点或第（b）点规定的条件（见下文第C部分）。
根据MDCG指南2020-3，在过渡期内，公告机构不能签发新的MDD/AIMDD证书。但是，公告机构可以提供书面确认，纠正或补充现有证书上的信息。
制造商可能需要向第三方证明证书的有效性（例如，为了进入第三国市场或在采购过程中投标）。为此，制造商应能通过不同的方式来证明其器械在过渡期延长所覆盖的范围内以及证书有效。
制造商应该能够提供一份自我声明，确认满足延期的条件，并说明过渡期的结束日期。自我声明可以基于统一的模板。自我声明应明确指出延期所涉及的器械和相关证书。额外的证据可以借助公告机构发出的“确认函”，说明公告机构已收到制造商的符合性评估申请并与制造商签订书面协议。确认函应明确指出延期和相关证书所涵盖的器械。确认函可以基于统一的模板，原则上无需额外的费用便可签发。
成员国主管当局应能在延长的证书有效期内签发自由销售证书。
欧盟委员会将为非欧盟/欧洲经济区国家的主管当局、医护专业人员和医疗机构以及采购生态圈更新其情况说明书（Factsheet），解释过渡期延长的运作情况。
第C部分 - 从MDR过渡期延长中受益需满足的条件
8.制造商提交正式申请所需的要素是什么？
根据MDR第120条第3c款第（e）点，制造商或授权代表必须在2024年5月26日之前按照MDR附录VII第4.3节第1段的规定向公告机构提交正式的符合性评估申请。制造商和公告机构必须在2024年9月26日之前按照MDR附录VII第4.3节第2段签署书面协议，以享受延长的过渡期。
MDR第120条第3c款第（e）点并未提及根据MDR附录VII第4.3节第3段对申请进行审查。这意味着，在签署书面协议之前，不需要公告机构对申请进行全面审查。
原则上，申请应包括MDR附录IX ~XI中提及的相关符合性评估中所列的内容。然而，需要考虑的是，在签订书面协议之前不需要对申请进行全面审查，而且从申请的最后期限（2024年5月）到制造商和公告机构实际执行符合性评估活动之间的时间跨度可能很长（最晚到2028年）。因此，公告机构在与制造商签订书面协议时不需要的文件以及制造商在实际符合性评估前可能更新的文件不需要与申请一起提交。
这意味着，申请时不需要提交其所涵盖的需要接受技术文件评审的每个器械的技术文件。但是，申请时必须清楚地标识制造商和申请所涵盖的器械（例如，通过包含计划转移到MDR的器械列表以及（在适用情况下）旨在替代“遗留器械”的器械的相关信息）。与申请一起提交的信息需足以让公告机构核实产品作为器械的资格、产品各自的分类以及所选择的符合性评估程序。在提交申请时，制造商应提供可能提交单个技术文件和任何其他相关信息的时间表。公告机构和制造商应就在适当时间提交符合性评估活动所需的相关技术文件或其他信息的计划达成一致。
由于制造商最迟需要在2024年5月26日之前符合MDR的质量管理体系（QMS）要求，因此对QMS的符合性评估申请应包括制造商的QMS文件。
如果制造商提交旨在替代遗留器械的器械的符合性评估申请，制造商不仅需要明确替代器械，还需要明确拟被替代的遗留器械，替代器械的技术文件可以在后面的阶段提交。
9.制造商和公告机构之间的书面协议所需包含的要素有哪些？
根据MDR第120条第3c款第（e）点，公告机构和制造商必须在2024年9月26日之前签署符合MDR附录VII第4.3节第2段相关要求的书面协议。MDR附录VII第4.3节第2段的要求尚未修订。
制造商或授权代表提交的正式申请（见本文件第8个问题）应作为签署书面协议的基础。书面协议应包括提交申请时未提供的相关文件（如正式申请所涵盖的所有器械的完整技术文件）的提交时间表。
为了促进公告机构之间的一致性，NBCG-Med（公告机构协调小组）与MDCG工作组公告机构监督分组（NBO）达成一致，可能会对MDR第120条第3c款第（e）点中提及的公告机构与制造商之间签署的书面协议中应包括的标准要素进行额外的澄清。
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
原文链接：https://health.ec.europa.eu/latest-updates/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en
