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Brush up on your knowledge of airspace, including TFRs, download a kneeboard guide for intercept procedures, learn about requirements for flying through the outer ring of some TFRs, and see what it’s like to fly into the Washington, D.C., Flight Restricted Zone.
1 mar 2023 · • AOPA’s Adaptable medical devices – current requirements • AOPA’s Definition guide for the TGA terminology For specific guidance, please contact the Advocacy and Policy Officer at AOPA or the Personalised Medical Devices Team at the TGA. Overview This document outlines the regulatory requirements for patient-matched orthotic ...
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
1 mar 2023 · • AOPA’s Custom-made medical devices – current requirements • AOPA’s Definition guide for the TGA terminology For specific guidance, please contact the Advocacy and Policy Officer at AOPA or the Personalised Medical Devices Team at the TGA. Overview This document outlines the regulatory requirements for adaptable orthotic/prosthetic ...
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.
26 maj 2021 · The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products.
