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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    Examples of medical devices with an ancillary medicinal substance include: drug-eluting stents; bone cement containing an antibiotic; catheters coated with heparin or an antibiotic agent; condoms coated with spermicides.

Your Guide to European CE Mark for Medical Devices - Essenvia

    https://essenvia.com/blog/eu/your-guide-to-european-ce-mark-for-medical-devices
    Class III medical devices are considered high risk and often require lifetime monitoring. Examples include internal pacemakers, prosthetic heart valves, and …

CE Marking of Medical Devices | mdi Europa

    https://mdi-europa.com/ce-marking/
    Fundamental as well as up to date information on CE Marking and CE Marking approval process in full depth CE Approval MDR – Medical …

List of Products Covered by CE Marking: An Overview

    https://www.compliancegate.com/ce-marking-product-list/
    Here are some directives and regulations for which the CE mark is mandatory: RoHS Directive; Low Voltage Directive; EMC …

List of CE Marking Directives and Regulations: An Overview

    https://www.compliancegate.com/ce-marking-directives/

    CE Marking for Medical Devices - Johner Institute

      https://www.johner-institute.com/articles/regulatory-affairs/and-more/ce-marking/
      The first precondition that a manufacturer affixes the CE mark is that the medical device fulfills the "essential requirements" as laid out in Annex I of MDD, respectively the …

    IS there any database for list of CE marked Medical …

      https://elsmar.com/elsmarqualityforum/threads/is-there-any-database-for-list-of-ce-marked-medical-devices-and-there-current-status.72115/
      Medical Devices Coordination Group (MDCG); Notified Bodies (NBs); Economic Operators (EOs - manufacturers, authorised representatives, importers, …

    List of Notified bodies accredited for Medical Device CE Marking

      https://www.ce-certification.us/notified-body.html
      Medical device CE Marking consists of two stage audit. Generally the stage one audit is ...

    List of all CE marking certificates Notified Bodies can …

      http://www.ce-marking.com/medical-device/all-certificates-notified-bodies-can-issue-under-3-medical-devices-directives.html
      Class IIa medical devices CE Marking procedures; Class IIb medical devices CE Marking procedures; Class III medical devices CE Marking procedures; IVD-In Vitro Diagnostic medical devices CE Marking …

    Tasso secures CE mark for high-volume liquid blood collection …

      https://www.nsmedicaldevices.com/news/tasso-secures-ce-mark-for-high-volume-liquid-blood-collection-device/
      US-based clinical-grade blood collection solutions provider Tasso has received a CE mark for its new high-volume liquid blood collection device, TassoOne …



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