의료기기 이야기

[Emergo, UL] Global Dates Format and Use of ISO Standard

Many medical device manufacturers struggle when it comes to choosing from among the wide variation of date formats used around the world. The format of dates (date/month/year, year/month/date or month date year) still poses a morass to medical device manufacturers. As a global consultancy, we understand the importance of respecting regional conventions. We also recognize different preferences. H..

The new Great Britain (GB) vigilance report schema goes live on Monday, June 16 in alignment with the timing of the new post-market surveillance (PMS) regulations coming into force. The GB regulator has updated its online guidance hub with resources intended to assist with the implementation of the new schema. The Medicines and Healthcare products Regulatory Agency (MHRA) has long leveraged the ..

For the evaluation of health supply registrations, Mexico’s Federal Commission for Protection of Sanitary Risks (COFEPRIS) released a new agreement for the equivalency requirements established in articles 167, 170, 177, 177 Bis 2, 179 and 180 of the Health Supplies Regulations and the technical evaluation procedures performed by COFEPRIS. In these cases, the COFEPRIS review is abbreviated.Equiva..

As previously reported, during a public consultation launched in November 2024, the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), proposed removing the revocation dates of four pieces of assimilated EU law so that they remain part of the statutory framework for medical devices in Great Britain (GB) until they are replaced with the updated UK law. U..

As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included. The European Medical Devices Regulation 2017/745 (MDR) and the European In Vitro Diagnostic Device Regulation 2017/74..

What is an IRB and what does a submission look like?An IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. An IRB submission for human factors research consists of the research protocol, informed consent form(s), assent form(s) (if applicable), recruiting screeners and the principal investigator (..

The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici..

The requirements for AI literacy per the European Artificial Intelligence Act (AIA) came into force on February 2, 2025. This was discussed in our webinar. To provide further guidance, the EU Commission published (May 7) an FAQ on this topic. AI Literacy Per the European AI Act AI Literacy Per the European AI ActAs medical device manufacturers increasingly integrate AI technologies, the respon..

EUDAMED Workshop & Training ▶ 일시: 2025년 05월 21일 EUDAMED Workshop – 21 May 2025 - Stuttgart, Germany - European Commission EUDAMED Workshop – 21 May 2025 - Stuttgart, GermanyEUDAMED Workshop – 21 May 2025 - Stuttgart, Germanyhealth.ec.europa.eu

The medical device regulator in South Africa, the South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System (QMS) developments.SAHPRA joins MDSAPSAHPRA announced (April 4, 2025) affiliate member status has been bestowed upon the Medical Device Single Audit Program (MDSAP). SAHPRA Chief Executive Officer Dr. Boitumelo Semete-Makokotlela hailed ..