NOTICE 导航已提供中文版本。受控的法规内容与文件在正式审核的译本发布前,仍以批准的英文或土耳其文提供。

以证据为依据的更新

新闻与法规更新

企业新闻与法规信息分开呈现,均标注日期并链接至权威来源。

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01

NOTICE 加入 Applus+ Laboratories

Applus+ Laboratories 于 2025 年 7 月 17 日宣布收购 NOTICE,进一步扩展其医疗器械合格评定能力。

打开权威来源
02

法规更新

本栏目将发布经批准的更新内容,并附发布日期、生效日期、来源及受影响的流程。

源站点存档 以下历史公告仅为防止内容丢失而保留,并非现行 MDR 指南或操作说明。
Legacy / transitional

Extension of MDD certificates

The source-site MDD extension announcement is retained for historical and transitional reference.

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Legacy / transitional

Designation under Directive 93/42/EEC

The source MDD designation announcement is not a current statement of MDR scope.

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QMS verification pending

ISO/IEC 17065 accreditation announcement

The source announcement is preserved pending confirmation of its date and continuing public relevance.

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Historical

ISO 13485 accreditation announcement

The source referred to ISO 13485:2012 and is retained only with historical context.

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QMS verification pending

Certification methods and procedures published

The source publication notice is retained while current codes, revisions and effective dates are verified.

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