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Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Conducting a Comparative Analysis in Lieu of HF Validation Testing▶ 일시: 2024년 05월 09일 EST 10시 (한국시간: 05월 09일 23시)  A common way to conclude whether a product can be used safely and effectively as intended by the intended users in the intended use environment is to conduct a human factors (HF) validation test. However, it might be appropriate and acceptable ..

What is an investigator’s brochure? The investigator’s brochure (IB) is referenced in the European Medical Devices Regulation (2017/745, MDR). However, those unfamiliar with the term IB will find it defined in Annex XV, Chapter II, Section 2. In the interest of completeness, there is a catch-all expectation in MDR Article 62 on clinical investigations. MDR Article 62(4)(m) states “the requiremen..

Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil. Background to RDC 741/2022 and September 2023 consultation ANVISA announced RDC 741/2022 (August 10, 2022) to establish a resolution to leverage registrations from foreig..

As previously reported by Emergo by UL, Brazilian medical device and IVD market regulator ANVISA has released three guidance documents to further clarify Resolution RDC 830/2023. Of interest to this post is the document regarding IVDs with a changed risk classification. The IVDs are presented in five tables: Class III to Class II, Class II to Class III, Class IV to III, Class II to IV, and Class..

March in Europe The European Commission (EC) updated several medical device safety regulation documents in March 2024. This includes additional standards harmonized with the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR) and published in the Official Journal of European Union (OJEU). It also includes an updated study on Notified Body appli..

Emergo에서 아래와 같이 웨비나를 개최한다. ​ ▶ 주제: Singapore HSA - Thai FDA Reliance Program for Medical Devices ▶ 일시: 2024년 04월 18일 CST 9시 (한국시간: 04월 18일 23시) Join us on April 18 for an insightful webinar led by our subject matter expert Sreenu Sattu. He will provide a comprehensive overview of the latest Thai FDA Reliance Program and its impact on facilitating the registration process in Thailand, particularl..

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..

The European Commission (EC) has made a proposal (COM(2024)43/ 5712/24) to delay compliance of legacy IVD devices and for EUDAMED to be rolled out by modules completed. The proposal would extend the time for manufacturers of legacy IVDs to become compliant with the IVDR. Also, analogous to Regulation (EU) 2023/607, requires an application with a notified body designated for the IVDR and an agree..

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..