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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …

Medical Device Regulation comes into application

    https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
    Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May …

ANNEX I Medical Device Regulation - GENERAL SAFETY AND …

    https://lexparency.org/eu/32017R0745/ANX_I/
    Devices incorporating materials of biological origin For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non …

Medical Devices - New regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations_en
    The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready Manufacturer IVD Manufacturers MD Manufacturers …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    The EU Commission published three new Factsheets describing the implications of the new Regulations on various stakeholders: (1) Factsheet for Authorised Representatives, …

Biological hazard applications: regulations and guidance …

    https://www.efsa.europa.eu/en/applications/biologicalhazard/regulationsandguidance
    EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 19 December 2022) Applicable to applications submitted …

EU MDR Delay and Biocompatibility

    https://www.mddionline.com/regulations/eu-mdr-delay-what-does-it-mean-biocompatibility-and-chemical-characterization
    The year 2020 was already going to be an “exciting” one for medical device companies, thanks to all the regulatory and standards changes with the new EU …

Biological Safety & European Medical Device Regulations

    https://books.google.com/books/about/Biological_Safety_European_Medical_Devic.html?id=YAKki28q0y8C
    Biological Safety & European Medical Device Regulations Quality First International 0Reviews Reviews aren't verified, but Google checks for and removes fake content when …

GSPR: General Safety and Performance Requirements for medical devices ...

    https://mdrc-consulting.com/gspr-en/
    GSPR: General Safety and Performance Requirements for medical devices in the EU. GSPR or General Safety and Performance Requirements is a concept specific to European medical device legislation, one of the central concepts of European Medical Device (MDR) and In Vitro Medical Device (IVDR) Regulations. As the name suggests, GSPR …

[PDF] Book Biological Safety European Medical Device …

    https://jaimesilva.co/pdf/biological-safety-european-medical-device-regulations/
    The new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are changing the rules of the game in this important area of health care. It is now …



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