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CE Technical Dossiers 

15 Years of Experience
Preparing technical dossiers for CE marking approval and providing full guidance and support
3 European medical device directives

 
CE Medical Devices Directive
EC Directive 93/42/EEC
  • EC Directive 93/42/EEC
  • AIMD - Active Implantable Medical Device Directive 90/385/EEC
  • IVD - In-Vitro-Diagnostic-Device Directive 98/79/EC
  • There are three European CE marking directives that specifically apply to medical device manufacturers:
  • The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
  • The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
  • The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.

There are 3 main directives in the European medical device field:

  1. General medical equipment
  2. Equipment for labs
  3. Active implants  
 
In order to market medical devices in Europe , manufacturers of Class I sterile,  and Class I with measuring function, IIa ,IIB, III need CE and ISO 13485, these certificates serve as an entrance ticket into the European marketing world.
 

The main stages on the route to receive a CE mark are:

  1. Defining the device and its intended use.
  2. After defining it - classification in one of the risk classes - Class I IIa, IIb or III.
 
Preparation of a technical dossier to submit to an authorized notified body  in Europe,  according to the company’s quality control procedures and ultimately an audit conducted by the notified body.
 

L.S.Marketing & Registration - Experts in the Medical Devices Field

A team with vast experience - 15 year’s experience in the medical device industry, expertise in registration of a wide range of medical devices.
 
We are very familiar with many companies both in Israel and worldwide.
  

Preparation of CE technical dossiers - the service includes:

  • Preparation of a technical dossier in cooperation with the manufacturer for the notified body.
  • Reducing costs of accreditation of  notified bodies.
  • Preparation for external audit by the notified body.
  • If the products are Class I not sterile - if necessary - assistance with finding the right  European Authorized Representative - acts as a representative body in Europe to local health authorities.

Let us, the professionals, be there with you!!!

Your Success is Assured with us!!!

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L.S.Marketing & Registration
19 Harduf St.
Tzur Yigal

Shuki Nadel +972-54-8058871
Liat Nadel  +972-52-3516078

 

Contact us

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עיצוב גרפי: סטודיו עדנה ריקלין
 We will guide you safely through the world of medical regulations - 
we are your full partners in the process
     
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