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您可订阅电子月报，我们将通过电子邮件，每月为您发送医疗器械法规动态汇总。

最新动态

15 五月 2023

PSUR and SSCP/SSP >

Article 86 of EU MDR 2017/745 requires manufacturers of Class IIa, IIb and Class III devices to generate a PSUR and Article 81 of EU IVDR 2017/746 requires manufacturers of Class C and D devices to generate a PSUR.

25 五月 2023

Sterile medical devices >

BSI announces new scope designation to include non-standard sterilization modalities for sterile medical devices

07 六月 2023

UKCA extension >

On 27th April 2023, the MHRA officially announced acceptance of Amending Regulation (EU) 2023/607 and an additional twelve-month extension to the current standstill period.

10 五月 2023

BSI issues certificate for IVD Companion Diagnostic (CDx) device >

Full scope Notified Body BSI The Netherlands (2797) is pleased to announce the issue of its first CDx certificate under the In Vitro Diagnostics Regulation (IVDR (EU) 2017/746).

12 七月 2023

BSI awarded ISO 13485 accreditation by SAC >

From 1 January 2025, only ISO 13485 issued by SAC accredited Certification Bodies will be accepted for Medical Devices license applications in Singapore.

07 七月 2023

BSI issues 1000th MDR certificate >

BSI has achieved a significant milestone by issuing its 1000th Medical Devices Regulation (MDR) Certificate.

20 三月 2023

关于Class D类器械的IVDR修正案和政策 >

IVDR Article 110.4 中的销售(Sell off)条款已废除，允许已根据指令投放市场的遗留器械继续销售，不设截止日期。

30 一月 2023

ISO 13485 changes to audit durations >

As a company certified by BSI Group pursuant to the requirements of ISO 13485, and we would like to inform you of the following change to audit durations.

09 二月 2023

BSI签发首张Class D IVDR证书 >

2023 年 1 月 11 日，BSI IVDR 公告机构签发了首张符合IVDR Annex IX Chapter II Class D的 IVDR 证书。该认证器械的制造商是 Roche Molecular Systems，其用途是为献血者进行 HEV 感染筛查。

20 三月 2023

欧盟MDR法规过渡期延长Regulation (EU) 2023/607 >

2023 年3月20日，修订 MDR 和 IVDR 的 Regulation (EU) 2023/607号法规在《欧盟官方公报》(Official Journal of the European Union, OJEU) 上公布，并立即生效。本次法规修订旨在化解当前的严峻形势，解决由于从医疗器械指令向MDR和IVDR法规的过渡不如预期而导致的欧盟医疗器械短缺问题。

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