CE Marking Medical Devices QNET's medical device experts can assist you in complying with the Medical Device Directive and In Vitro Diagnostic Medical Device Directive. Our Authorized Representative office in The Netherlands communicates and deals with the Competent Authorities and Notified Bodies on your behalf. Self-Certification Risk Class 1 QNET offers affordable assistance through its EU ENTRY-PACKAGE. EU Entry Package A systematic seven step system. European Authorized Representative What is the role of the Authorized Representative The New EU Foreign Language Labeling Requirements Explains the confusing translation requirements for 22 languages. PDF FILE. 2003 Focus on Risk Class I Device due to fatalities. Fatalities involving patient lifts. European Court decision update on first product liability case Medical Device or PPE Some medical devices may actually be PPE and some PPE products may be medical devices. Orthotic and Prosthetic devices CE Marking CE Marking Custom made and adaptations explained Notified Body Survey We asked 5 Notified Bodies for a quotation. The results are here. Medical Devices Outside the EU Australia Re-usable disposable devices End users are using the single use device again and again