European Medical Device Directives

  • Medical Device Directive (MDD 93/42/EEC)
    this directive covers most medical devices (active and non-active) and their accessories that are not covered by the In-Vitro Medical Directive or the Active Implantable Medical Device Directive. This concerns a large number of products ranging from walking aids to prosthetic heart valves.
  • In Vitro Diagnostic Medical Device Directive (IVD 98/79/EC)
    this directive will cover any reagent, reagent product, control material, kit, medical device, instrument, apparatus or system which is intended to be used in-vitro for the examination of substances derived from the human body.
  • Active Implantable Medical Device Directive (AIMDD 90/385/EEC)
    this directive covers all medical devices, which rely for their functioning on a power supply and are left in the human body. Examples of AIMD’s are implantable cardiac pacemakers, implantable nerve stimulators and implantable drug administration devices with or without catheter.

To gain market access in the European Union, you have to compile a Technical File (or Design Dossier for Class III products) demonstrating compliance to the Medical Device Directives and implement relevant quality procedures for meeting the quality requirements set out in the appropriate Annex.

When you are ready, you can lodge an application for conformity assessment with a Notified Body, or in case of Class I devices, notify a competent authority. If you are not located in the European Union, you need to appoint an European Authorized Representative.

Qserve offers a training program for European market access, check our flyer or the training section of this website.

What can we do for you?

Technical Dossier Set Up

 

Notified Body Selection

 

ISO 13485 Implementation

 

Clinical Evaluation Report

 

Software validations

 

GAP Analysis

 

Want more information? Get in touch with us

Information request