Traduction de «european directives regarding medical devices » (Néerlandais → Français) :

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.

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.

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.

De Europese Commissie heeft een voorstel tot “Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001l83/EC on the Community code relating to medicinal products for human use” goedgekeurd (bijlage).
La Commission européenne a déposé une proposition de “Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use” (cf. annexe).

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.

1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines
1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines

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.

Voor een uitgebreider inzicht in de geharmoniseerde normen bezoekt u [http ...]
Pour en savoir plus sur la liste des normes harmonisées, veuillez consulter [http ...]

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