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[Emergo, UL] UK MHRA Publishes Common Specification Requirements for IVD Devices

The Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation from May 20 to June 14, 2024, on their proposed amendments to the Medical Devices Regulations 2002 (MDR 2002) regarding the Common Specifications (CS) requirements for certain high-risk in vitro diagnostic (IVD) devices, including COVID-19 tests. In this blog, we discuss the outcome of the consultation and th..

This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market. The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted a webinar in March on the update of the draft medical devices scope, classification and essential requirements. This was a..

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by ..

MDCG에서 발행된 문서를 기반으로 제조업체와 유럽대리인을 대상으로 설문조사를 진행하고 있다. 관심이 있으신 업체의 경우에는 확인 바랍니다. ▶ 기간: 2024년 01월 15일까지 (CET 23:59:59 까지) EUSurvey - Survey (europa.eu) Study supporting the monitoring of availability of medical devices on the EU market Surveys for MD and IVD manufacturers and aut ec.europa.eu