Vertaling van "devices the european medical devices " (Nederlands → Frans) :

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Medical devices The European medical devices directives are socalled New Approach Directives: the products can be commercialised without the involvement of the competent authorities.
Medical devices The European medical devices directives are socalled New Approach Directives: the products can be commercialised without the involvement of the competent authorities.

At European level, important texts were adopted such as Directive 2007/47/EC amending Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, and Regulation (EC) no. 1394/2007 on advanced therapy medicinal products.
At European level, important texts were adopted such as Directive 2007/47/EC amending Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, and Regulation (EC) no. 1394/2007 on advanced therapy medicinal products.

d) heeft elke gemachtigd gebruiker die over een elektronische identiteitskaart beschikt toegang tot de toepassingen “Shared Artritis File for Electronic Use (SAFE)”, “Raadpleging van de wilsverklaring inzake euthanasie - eutha-consult”, “ORTHOpedic Prosthesis Identification Data - Electronic Registry - ORTHOpride®”, “Project on cancer of the rectum - Central Image Repository (PROCARE RX)”, “Qermid(c)Pacemakers-Quality Electronic Registration of Medical Implant Devices”, “SMUREG”, “Medico-Administratieve Stromen – Thuisverpleging (MEDADM-INF)”, “ZNA - Zorgportaal – SARAi”, “Registratie van Therapeutische Projecten (TherPro – PatientRegistration)”, “Medega”, “QermidDefibrilateur-Quality Electronic Registration of Medical Implant Devices”, “eHealthBox”, “QermidEndoprothèses-Quality Electronic Registration of Medical Implant Devices”, “QermidPacemakers-Quality Electronic Registration of Medical Implant Devices”, “QermidTuteurs Coronaires- Quality Electronic Registration of Medical Implant Devices”, “Registratiemodule van de Belgische Virtuele Tumorbank”, “Catalogus van de Belgische Virtuele Tumorbank”, “CIVARS – Chapter IV Agreement Requesting System”, “Web Application Metahub”, “Raadpleging van medische kaart”, “TDI - Registratie Module van de “Treatment Demand Indicator””, “eShop - Online bestelling getuigschriften voor verstrekte hulp (Medattest)”, “BNMDR - Belgian NeuroMuscular Disease Registry”, “eHealthConsent”, “Moduledatabank Jeugdhulp Vlaanderen” en “Authentieke bron geneesmiddelen”.
d) chaque utilisateur habilité qui dispose d’une Carte d’Identité Electronique a accès aux applications « Shared Artritis File for Electronic Use (SAFE) », « Consultation de la déclaration anticipée d’euthanasie- eutha-consult », « ORTHOpedic Prosthesis Identification Data - Electronic Registry - ORTHOpride® », « Project on cancer of the rectum - Central Image Repository (PROCARE RX) », « Qermid(c)Pacemakers- Quality Electronic Registration of Medical Implant Devices », « SMUREG », « Flux Medico-Administratifs - Infirmier A Domicile (MEDADM-INF) », « ZNA - Zorgportaal – SARAi », « Enregistrement des projets thérapeutiques (TherPro – PatientRegistration) », « Medega », « QermidDefibrilateur-Quality Electronic Registration of Medical Implant Devices », « eHealthBox », « QermidEndoprothèses- Quality Electronic Registration of Medical Implant Devices », « QermidPacemakers- Quality Electronic Registration of Medical Implant Devices », « QermidTuteurs Coronaires-Quality Electronic Registration of Medical Implant Devices », « Module d’enregistrement de la Tumorothèque Virtuelle Belge », « Catalogue de la Tumorothèque Virtuelle Belge », « CIVARS – Chapter IV Agreement Requesting System », « Web Application Metahub », « Consultation des cartes médicales », « TDI

The European directives regarding medical devices are referred to as the New Approach Directives. Products may be commercialised without the intervention of a competent authority.
The European directives regarding medical devices are referred to as the New Approach Directives. Products may be commercialised without the intervention of a competent authority.

Medical devices with the CE marking can move freely within the European Union.
Medical devices with the CE marking can move freely within the European Union.

The manufacturer also submits a declaration of conformity with the European medical devices directive.
The manufacturer also submits a declaration of conformity with the European medical devices directive.

ACE Angiotensin Converting Enzyme ACS Acuut Coronair Syndroom AMI Acuut Myocard Infarct BIS Bispectral index BMS Bare Metal Stent CABG Coronary Artery Bypass Graft CVA Cerebrovasculair Accident DES Drug Eluting Stent EKG Electrocardiogram ESC European Society for Cardiology GP General Practitioner IABP Intra-Aortic Balloon Pump INVOS In Vivo Optical Spectroscopy KI Kwaliteitsindicatoren NSTE-ACS Geen ST-segment verhoging, Acuut Coronair Syndroom OPCAB Off-pump coronary artery bypass PCI Percutane Coronaire Interventie QERMID Quality Electronic Registration of Medical Implant Devices (RIZIV – INAMI) SLA Service Level Agreement SOP Standard Operating Procedure STEMI ST-Elevatie Myocard Infarct TEE Trans Esophageal Echocardiography URL Uniform Resource Locator VKF Voorkamerfibrillatie
ACV Accident Cérébro-Vasculaire BIS Bispectral index BMS Bare Metal Stent CABG Coronary Artery Bypass Graft DES Drug Eluting Stent ECG Electrocardiogramme ESC European Society for Cardiology FA Fibrillation Auriculaire GP General Practitioner IABP Intra-Aortic Balloon Pump IAM Infarctus Aigue du Myocarde ICP Intervention Coronarienne Percutanée ICU Intensive Care Unit I-ECA Inhibiteur de l’Enzyme de Conversion de l’Angiotensine INVOS In Vivo Optical Spectroscopy IQ Indicateur de qualité NSTE-ACS Non-ST-Segment Elevation Acute Coronary Syndrome OPCAB Off-pump Coronary Artery Bypass POS Procédures Opérationnelles Standard (SOP) QERMID Quality Electronic Registration of Medical Implant Devices (RIZIV – INAMI) SCA Syndrome Coronarien Aigu SLA Service Level Agreement / Accords sur les niveaux de service STEMI ST-Elevation Myocardial Infarction TEE Trans Esophageal Echocardiography URL Uniform Resource Locator

Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission