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On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

This is our fourth update on the recently released draft standard for medical device labeling published by Mexico’s medical device regulator COFEPRIS, NOM-137-SSA1-2024. Background on NOM-137-SSA1-2024COFEPRIS released (March 12) a new draft of the NOM for Medical Device labeling, NOM-137-SSA1-2024. We posted part 2 and part 3, to further clarify the proposed medical device labeling standard. In..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..

We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical de..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Medical Device Software and Cybersecurity▶ 일시: 2024년 05월 14일 CST 10시 (한국시간: 05월 14일 23시)  As medical devices become more and more interconnected — and the applications of medical device software grow exponentially — there is a need to ensure that these devices, when placed on the market, are safe and effective and remain in this state throughout their lifetime. I..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Revised IVD Regulation RDC 830/2023▶ 일시: 2024년 04월 30일 CST 9시 (한국시간: 04월 30일 23시)  The ANVISA – Agência Nacional de Vigilância Sanitária  issued Resolution RDC No. 830/2023, on Dec. 11, 2023. The resolution is intended to help IVD medical device manufacturers determine what information is required in a registration submission. The Resolution outlines a new ..

This is the first in a series of regulatory updates on the labeling standard in Mexico.What is a medical device NOM in Mexico?In simple terms, a Norma Oficial Mexicana is a Mexican regulatory standard that manufacturers meet to protect the safety of medical device, IVD and pharmaceutical users.The Mexican Secretariat of Health is the agency in charge of enforcing the national health policy an..

The Hong Kong (HK) medical device regulatory systemMedical device makers who want to access the Hong Kong market must be aware of the latest regulatory requirements in this special administrative region of China. New developments in Hong Kong’s medical device market include additional leveraged country authorizations and a new digital platform.The HK Medical Device Division (MDD) and the Medic..

The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023. C..

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 ..