Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for…
Posts published in July 2019
September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement
LA AEMPS COMIENZA EL PROCESO PARA SER DESIGNADA COMO ORGANISMO NOTIFICADO DE ACUERDO AL MDR
Center for Devices and Radiological Health (CDRH) Appeals Processes
Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April…
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory…