CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

EUROPEAN COMMISSION DG  Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies  Health technology and Cosmetics ABSTRACT 1. Introduction   Pursuant to  - section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to  - section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC),  the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC.  This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices.  The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question....

“Excellence in International Orthodontics” International Master. All the speackers are important reference points in orthodontic World views. The arguments are current and interesting. There is a practical, too with meeting during Thursday before Master. The cost would be 3000 Euros. It is mostly covred by “Orthocaps & Win” two included certifications. Program

Master Internazionale “Excellence in International Orthodontics” Tutti i relatori  rappresentano dei veri punti di riferimento nel panorama ortodontico mondiale.  Gli argomenti proposti sono tra i più interessanti e attuali. Il corso è anche pratico con incontri che si svolgono il giovedì precedente al Master. Il costo di 3000 euro è in gran parte coperto dalle due Certificazioni incluse "Orthocaps & Win”. Master Base “Basic Orthodontics”   Rappresenta  una splendida occasione per chi vuole approcciare questa affascinante disciplina.  Coloro che intendono iscriversi troveranno tutti i Tutor pronti ad indirizzarli e seguirli su questo interessante percorso. Gli argomenti consentono di avere una preparazione di base completa ed esauriente. Il corso è anche pratico con incontri che si svolgono il giovedì precedente al Master. Il costo di 2400 euro è in gran parte coperto dalla Certificazione "Orthocaps” inclusa.  Programma ...

From website "Much UK regulatory law originates from the EU. Most of it comes from EU Directives which the UK has implemented into our national law. Examples are Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) and Directive 89/105/EEC, regulating the pricing of medicinal products for human use and their inclusion in national health insurance schemes. Some of it is derived from EU Regulations which are directly applicable in the UK, without the need for any implementing legislation here. An example is Regulation 726/2004 on the authorisation and supervision of medicinal products and establishing the European Medicines Agency. This briefing considers some potential impacts of a vote to leave the EU (“Brexit”) on regulatory aspects of healthcare and life sciences." Go to complete article>Click Here

Updated to / Aggiornamento al  22.07.2016 Weekly overview report of RAPEX notifications LINK> REPORT RAPEX EN RAPEX is established as the EU rapid alert system that facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. As of 2010, the system also facilitates the rapid exchange of information on products subject to EU harmonisation regulation and posing a serious risk to the health and safety of professional users as well as on those posing a serious risk to other public interests protected via the relevant EU legislation (e.g. environment and security). Both measures ordered by national authorities and measures taken 'voluntarily' by producers and distributors are reported by RAPEX. Every...