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The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - commissioned a “Stud on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market". The study started in December 2022 and was performed over 14 months. It was contracted to a consortium led by the Austrian..

Background - EURL designation 2023 In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. Applicant laboratories had six months to prepare and submit applications to their Member State. The Commission reviewed the applications based on the following elements specified in the call: the applicant laboratories must ..

In Vitro Diagnostic (IVD) devices are a critical component of healthcare, as they help users diagnose conditions and formulate an appropriate treatment plan for a patient. In some cases, they may also be used for care management for certain diseases. In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a spec..

Emergo에서 아래와 같이 웨비나를 개최한다. ▶ 주제: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 02월 29일 자정) The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is not only affecting legal manufacturers (companies) but also clinical laboratories using in-house tests. Though not all requirements apply to clinical laboratories, they must ma..

The start of 2024 has seen a flurry of activity from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) regarding medical device legislation.These updates have greatly increased the UK’s capacity to certify medical devices. Since the publication of the UK regulatory roadmap (January 9), there have been several significant updates to the list of UK-approved bodies for medical devices, inc..

The first deadline for Regulation 2023/607 is rapidly approaching. Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met. About Regulation 2023/607 We briefly share again the requirements for Regulation 2023/607 amending the European Medica..

To help medical device and IVD manufacturers understand the national language requirements under the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), the European Commission recently published two tables on its website (January 17) with links for the relevant legal provisions for each member state. The MDR and IVDR contain regulatory require..

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by ..

Emergo by UL 에서 MDR 관련하여 최근에 발표한 Regulation (EU) 2023/607과 관련된 내용으로 웨비나를 진행한다. ▶ 일자: 2024년 01월 18일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 45분 동안 진행 예정 ▶ 링크 Regulation EU 2023/607 Frequently Found Issues | Emergo by UL Regulation EU 2023/607 Frequently Found Issues In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about Regulation EU 2023/607. www.em..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS). Products without an intended medical purpose t..