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Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.RecapThe EU AIA  introduces a risk-based..

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek..

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 ..