随着（欧盟）2023/607号条例在《欧盟官方公报》上的公布，期待已久的MDR（欧盟）2017/745过渡期的延长生效了。截至2023年5月20日，MDD现有设备（根据MDR第120条被称为 "遗留设备"）的制造商可以从更长的设备认证期以及进一步的变化中获益：
- Extension of MDR transition period until December 31st 2027 for class III and class IIb implantable legacy devices.
- Extension of MDR transition period until or December 31st 2028 for other class IIb, class IIa and class Im and Is legacy devices, as well as devices qualified as class I under the directives but which conformity assessment procedure under the MDR requires the intervention of a Notified Body.
- Introduction of a transition period until May 26th 2026 for class III custom-made implantable devices.
- Removal of the "sell-off" period in the MDR (Article 120(4)).
However, the extension is subject to several conditions to ensure that only safe devices may benefit from the new transition period. Therefore, manufacturers must:
- By May 26th 2024, establish a quality management system (QMS) compliant with MDR; and
- By May 26th 2024, submit a formal application for the conformity assessment under MDR; and
- By September 26th 2024, have an mutually signed written agreement with the Notified Body for the conformity assessment under MDR.
In addition, the extension of the transitional regime only applies to MDR legacy devices that:
- Continue to comply with directive 93/42/EEC; and
- Do not present significant changes in design or intended use; and
- Do not present unacceptable risks to the health and safety of patients and users.
The new regulation also provides an additional requirement for legacy devices with an expired certificate. These products may only benefit from the extended transition period insofar as:
- The manufacturer – before the MDD's certificate's expiration – has concluded a contract with a Notified Body for conformity assessment under the MDR; or alternatively
- The manufacturer benefitted from an exemption under either Article 97 or 59 of MDR, which provide derogations from applicable rules in particular cases
The extension of the transition period meets the demands of the medical device industry, which has long been calling for a more flexible deadline to certify MDR legacy devices and is undoubtedly good news for medical device manufacturers. However, the need to meet the first deadline May 26th 2024 requires prompt action to ensure compliance with the new rules.
If you are interested or have any questions about this procedure, you can contact us here.
Your Notified Body DQS MED
将III类和IIb类植入式遗留器械的MDR过渡期延长至2027年12月31日。
将MDR过渡期延长至2028年12月31日，适用于其他IIb类、IIa类和Im类和Is类遗留器械，以及根据指令合格但根据MDR进行合格评定程序需要公告机构干预的器械。
引入到2026年5月26日的III类定制植入装置过渡期。
取消MDR中的“抛售”期(第120(4)条)。
然而，延长期限需要满足几个条件，以确保只有安全设备才能从新的过渡期中受益。因此，制造商必须:
2024年5月26日前，建立符合MDR要求的质量管理体系;和
2024年5月26日前提交MDR合格评定正式申请;和
在2024年9月26日之前，与公告机构就MDR下的合格评定达成相互签署的书面协议。
此外，过渡性制度的延长仅适用于MDR遗留器械:
继续遵守93/42/EEC指令;和
在设计或预期用途方面没有重大变化;和
不要对患者和使用者的健康和安全构成不可接受的风险。
新法规还对具有过期证书的遗留设备提供了额外要求。这些产品只有在下列情况下才能从延长的过渡期中受益:
制造商-在MDD证书到期之前-已与MDR下的合格评定公告机构签订合同;或者
制造商受益于MDR第97条或第59条的豁免，这条规定了在特定情况下对适用规则的克减
延长过渡期符合医疗器械行业的需求，该行业长期以来一直呼吁为MDR遗留设备提供更灵活的认证截止日期，这对医疗器械制造商来说无疑是一个好消息。然而，为了满足2024年5月26日的第一个截止日期，需要迅速采取行动，确保遵守新规则。
如果您对此程序感兴趣或有任何问题，您可以在这里与我们联系。
您的公告机构DQS MED
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作者
希蒙 库尔德
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