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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Get In Touch:
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July Newsletter 2024
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 2024...
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...
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...
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...
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...
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...
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...
December Newsletter
EU REGULATIONS MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into servic...
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