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News July 13, 2024 Cubicdesignz

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

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

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

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

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

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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12Jul 2024
EU, News, Regulations Cubicdesignz

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition      ...
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News July 10, 2024 admin

June Newsletter 2024 – Hebrew

אנו נרגשים לשתף אתהאחרונות בניוזלטר יוני שלנו!מה יש בפנים!!עדכונים על תקנות ותאימות של מכשירים רפואייםתקני בטיחות ומגמות עדכניות בתעשייה של מוצרי קוסמטיקהקבל תובנות לגבי אישורי תרופות וחדשות שוקקרא מידע מפורט למטה:June Newsletter Hebrew...
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News July 10, 2024 admin

June Newsletter 2024 – Japanese

6 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。中身は何だ！！1. 医療機器の規制と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. 医薬品の承認と市場ニュースに関する洞察を得る以下の詳細情報をお読みください。June Newsletter Japanese...
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News July 10, 2024 admin

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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