DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices
DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices
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- EU – SCHEER – Minutes of the Working Group meeting on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) of 15 January 2020
- SCHEER Safety of breast implants WG – minutes of 4 November 2019 meeting
- US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
- EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting
- TGA – Current status of breast implant products in Australia
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- EU – Guidance – Clinical evaluation assessment report template
- EU – Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)
- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- EU – Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
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