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Medical devices and Active Implantable Medical Devices

Medical Devices Directive 93/42/EEC and Directive 90/385/EEC

Medical Devices Directive 93/42 / EEC as amended
Active Implantable Medical Devices Directive (AIMDD) 90/385 / EEC as amended
 

IMQ SERVICES

IMQ is Notified Body for all procedures provided by Directive 93/42/EEC.
For Directive 90/385/EEC, IMQ is Notified Body for the procedures set out in Annex 2 (EC Declaration of Conformity - Full Quality Assurance System) and 5 (EC Declaration of Conformity to Type - Quality Assurance of Production)
 
Directive 93/42/EEC
It establishes a division of the Medical devices in 4 classes depending on the danger of the device itself. The manufacturer is required to identify the class of product based on the classification rules set out in the directive.
Class I devices do not require the intervention of a Notified Body. For Class > I devices, instead, manufacturers are requested to follow a certification procedure with a Notified Body such as IMQ.
 
Directive 90/385/EEC
It establishes the essential requirements and further requirements that Active Implantable Medical Devices have to meet in order to be placed on the market and / or put into service.
This Directive also defines the phases of compliance assessment procedures (schemes for Active Implantable Medical Devices certification), defining the mutual responsibilities of Manufacturer and Notified Bodies.
Among the main essential requirements that manufacturers and importers have to meet in order to apply CE marking to AIMD devices and legally placing on the market in EU countries, the following ones are point out:
• not to compromise the clinical status or the patient's safety
• not to pose any risk to people who implant them
• to guarantee the performances expected by the manufacturer
• to be designed to withstand storage and transport conditions.

All Active Implantable Medical Devices must undergo a conformity assessment procedure by a Notified Body such as IMQ.
 

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