From AAMI – FDA Recognizes AAMI Standard and TIR
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- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- EU – IMDRF Standards Checklist modified in scope of COVID-19
- US – AAMI Offers Free Standards and Resources to Help Fight Coronavirus
- Brasil – DECRETO Nº 10.229, DE 5 DE FEVEREIRO DE 2020 (in Portuguese)
- From RAPS – FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards
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- EU – Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- US – Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
- US – Update on the Ethylene Oxide Sterilization Master File Pilot Program
- US – FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
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