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News July 13, 2024 Cubicdesignz Comments: 0

November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories planning to apply in any of the EU Member states. The key topics included are as follows: Notified Bodies under MDR and IVDR | 21 November 2022 The 35th Notified Body, SGS Fimko Ltd, for Regulation (EU) 2017/745 on Medical Devices (MDR),...
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13Jul 2024
News Cubicdesignz Comments: 0

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). The topics covered in the guidance document are as follows: MDCG Guidance on Classification of IVD under IVDR | 10 February 2023 The MDCG 2020-16 rev.2 guidance addresses the requirement for the classification of IVDs under the classi...
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News July 13, 2024 Cubicdesignz Comments: 0

March Newsletter 2023

EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 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 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...
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News July 13, 2024 Cubicdesignz Comments: 0

April Newsletter 2023

Germany Database for In vitro diagnostics Medical Devices notification | 25 April 2023 In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG – Act on Medical Devices). The database is part of the German database-supported medical devices information and database system. Included therein is mainly administrative data and further data relevant to the notification. Finland Electronic submissi...
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News July 13, 2024 Cubicdesignz Comments: 0

May Newsletter 2023

EUROPEAN UNION (EU) Updated MHRA guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices. This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the ap...
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News July 13, 2024 Cubicdesignz Comments: 0

June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here. Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023 The position paper MDCG 2022-18 was publi...
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News July 12, 2024 Cubicdesignz Comments: 0

MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers 

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body tha...
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News July 10, 2024 admin Comments: 0

June Newsletter 2024 – Chinese (Traditional)

我們期待在六月時事通訊中分享最新的更新和見解。裡面是什麼！ ！有關醫療器械法規和合規性的最新信息化妝品安全標準及產業趨勢深入了解藥品審批和市場新聞請閱讀下面的更多資訊。June Newsletter Chinese (Traditional)...
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News July 10, 2024 admin Comments: 0

June Newsletter 2024 – Simplified Chinese

我们期待在六月时事通讯中分享最新的更新和见解。里面是什么！ ！有关医疗器械法规和合规性的最新信息化妆品安全标准及行业趋势深入了解药品审批和市场新闻请阅读下面的更多信息。June Newsletter Chinese (Simplified)...
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News July 10, 2024 admin Comments: 0

June Newsletter 2024 – Korean

6월 뉴스레터에서 최신 업데이트와 통찰력을 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !의료기기 규정 및 규정 준수에 관한 최신 정보화장품 안전기준 및 산업동향약물 승인 및 시장 뉴스에 대한 통찰력 확보아래에서 자세한 내용을 읽어보세요.June Newsletter Korean...
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