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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: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 03월 13일 23시) The presenter will provide more details on how to be best prepared for an external audit (FDA, MDSAP, ISO, etc.), as well as a practical approach to what to do before the audit and common pitfalls based on industry experience. We will also highligh..

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..

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..

Perhaps you have an idea for a medical device that could revolutionize medical care in the US, or perhaps for an improvement that could increase a device's safety or effectiveness. Bringing an innovative device to the U.S. market can present many challenges but also rewards. The US Food and Drug Administration (FDA) wants to encourage improvements to the overall safety and effectiveness of medic..

The European Commission’s Medical Device Coordinating Group (MDCG) has updated its priorities regarding the In Vitro Diagnostic Medical Devices Regulation (IVDR). The MDCG updated its Joint implementation and preparedness plan for the IVDR to reflect ongoing progress of its work and to set new priorities for the European Regulation (EU) 2017/746 (IVDR). IVDR plan organization The 20-page documen..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..