DECLARATION CE DE CONFORMITE

2 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Document Generated: 2020-12-15 Status: EU Directives are being published on this site to aid cross referencing from

Medical Device Directive 93/42/EEC CE-Marking What

the Directive and its support document/or s meddev 2 4/1 latest Rev and the Border Line manual latest version investigation: There are 6 risk classifications not to be compared with the US-FDA classifications: Annex II a) Risk Class I, Note: this is the only classification that qualifies for the self-certification compliance route in the

Directive 93/42/CEE - KONG

Directive 93/42/CEE Laden Sie die Übersetzung in Ihrer Sprache herunter - Download the translation in your langua-ge - Bájate la traducción en tu idioma - Télécharger la traduction dans vostre langue - Scarica la traduzione nella tua lingua ZZV001EN Rev 0

New medical device regulation: Understanding the transition

regulatory regime (Directive 93/42/CEE - MDD) will be still allowed on the European market In short, the MDR transition period allows some medical devices to remain legally on the European market until their full compliance with MDR has been declared ResMed has worked intensively for more than two years to update its quality

Monaco - WHO

Directive 93/42/CEE We have lists for Public health emergency situations known as “Plans d’urgence” Communicable diseases Non-communicable diseases Injuries Public health emergency situations x Healthcare facility Public sector Private sector Total Density per 100,000 population Health post n/a n/a n/a n/a Health centre n/a n/a n/a n/a