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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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