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august newsletter
04Sep 2024
News admin

August Newsletter 2024 – Japanese

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Japanese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Japanese...
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august newsletter 2024
04Sep 2024
News admin

August Newsletter 2024

We look forward to sharing the latest updates and insights in our August Newsletter 2024. What’s inside in August Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter 2024...
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News August 12, 2024 admin

July Newsletter 2024 – Japanese

2024 年 7 月のニュースレターで最新の更新情報と洞察を共有できることを楽しみにしています。中には何があるんだ！ ！1. 医療機器の法規制・コンプライアンスに関する最新情報2. 化粧品の安全基準と業界動向3. 2024 年 7 月の更新された ISO 規格のリスト詳細については、以下をお読みください。July Newsletter Japanese...
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News August 9, 2024 admin

July Newsletter 2024 – Korean

2024년 7월 뉴스레터에서 최신 업데이트와 유용한 정보를 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !1. 의료기기 규정 및 준수에 관한 최신 정보2. 화장품 안전기준 및 업계동향3. 2024년 7월 업데이트된 ISO 표준 목록자세한 내용은 아래를 읽어보시기 바랍니다.July Newsletter 2024 - Korean...
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News August 7, 2024 admin

July Newsletter 2024 – Chinese (Traditional)

We look forward to sharing the latest updates and insights in our July 2024 Newsletter. What’s inside! ! 1. The latest information on medical device regulations and compliance2. Cosmetics safety standards and industry trends3. List of Updated ISO Standards for July 2024 Please read below for more information. July Newsletter Chinese Traditional...
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News August 7, 2024 admin

July Newsletter 2024 – Chinese (Simplified)

We look forward to sharing the latest updates and insights in our July 2024 Newsletter.What's inside! !1. The latest information on medical device regulations and compliance2. Cosmetics safety standards and industry trends3. List of Updated ISO Standards for July 2024Please read below for more information.July Newsletter Chinese Simplified...
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Regulation (EU)
23Jul 2024
Regulations, News admin

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that o...
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IVDD
16Jul 2024
News, EU, IVD admin

EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers

On July 9, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) and took effect immediately. This new regulation aims to address the expected shortages of in vitro diagnostic medical devices (IVDs) in the EU due to the slower-than-expected transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR).  Following the removal of the sell-off provisions in Article 110.4, made official with Regulation (EU) 202...
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News July 13, 2024 Cubicdesignz

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021 Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence...
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News July 13, 2024 Cubicdesignz

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...
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