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  1. 5 de oct. de 2023 · Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data systems (MDDS), and sterilization systems ...

  2. 16 de may. de 2023 · From 1 December 2021 all implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs) and Patient Implant Cards (PICs), unless specifically excluded from these requirements.

  3. 1. MDCG 2021-24 Guidance on classification of medical devices. October 2021. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

  4. 11 de may. de 2021 · 3.3. Theme 3: Varying trust in sharing device information. Patients felt most comfortable with sharing their implanted device information within the medical profession—providers who would care for them and the hospital in which they would receive care. (I) have no problem with people knowing in the medical system

  5. 27 de jul. de 2023 · Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form ...

  6. 11 de feb. de 2019 · Medical devices can diagnose, monitor or treat disease and help people with physical impairments become more independent. Medical devices that people buy for personal use include: blood glucose ...

  7. GUIDANCE DOCUMENT. Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request Guidance for Industry and Food and Drug Administration Staff October 2017