Gruppo IMQ

Medical devices and Active Implantable Medical Devices

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

 
 

IMQ is a Notified Body to carry out the conformity assessment procedures of:

  • Medical devices pursuant to Directive 93/42/EEC as amended 
  • Active implantable medical devices pursuant to Directive 90/385/EEC as amended 

The areas of IMQ designation can be consulted at the following link: NANDO

IMQ has submitted the application for designation as a Notified Body for Regulation (EU) No. 2017/745 on medical devices that repeals Directive 93/42 /EEC and Directive 90/385/EEC 

 

Directive 93/42/EEC as amended concerning medical devices

 

Medical devices can be placed on the market or put into service only if they meet the requirements of Directive 93/42 /EEC and as amended, including the "essential requirements" set out in Annex I of the Directive itself.

 

According to their complexity and potential risk to the patient, medical devices are divided in the following risk classes: I, IIA, IIB and III. The manufacturer has the responsibility to classify his device by applying the rules defined in Annex IX of the Directive.

 

For CE-marking and placing on the market of the medical devices:

 

  • For class I Devices, the manufacturer must draw up the technical documentation referred to in Annex VII of the Directive and the declaration of conformity. The intervention of a notified Body is notrequired for this kind of devices.

     

  • For Devices in classes I in sterile conditions (IS), I with measuring function (IM), IIa, IIB and III, the manufacturer must choose a procedure - or a combination of procedures - for conformity assessment, as indicated in article 11 of the Directive, request the intervention of a Notified Body and obtain the attestation of conformity (EC certificate). 

     

Below, a brief description of the procedures for conformity assessment of medical devices as provided by Directive 93/42 /EEC as amended.

 

 DM1_en

The procedures carried out by IMQ and the related assessment procedure are described in the “IMQ Regulation for the certification of medical devices - CE Marking – Directive 93/42/EEC as amended” available in the “download” section herein below.

 

Directive 90/385/EEC as amended relating to active implantable medical devices

 

Active implantable medical devices can be placed on the market or put into service only if they meet the requirements of Directive 90/385 /EEC and as amended.
For CE-marking and placing on the market of the medical devices the manufacturer must request the intervention of a Notified Body and obtain the attestation of conformity (EC certificate)
Below, a brief description of the procedures for conformity assessment of medical devices as provided by Directive 90/385 /EEC as amended.

 

DM2_en

The procedures carried out by IMQ and the related assessment procedure are described in the “IMQ Regulation for the certification of active implantable medical devices - CE Marking – Directive 93/42/EEC as amended” available in the “download” section herein below.

 

Regulation (EU) 2017/745  (the “MDR”)

 

The Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, repealing the Directives 90/385/EEC and 93/42/EEC (hereinafter, the “MDR”), entered into force on 25thMay 2017 and will apply starting from 26th May 2020.

 

Information regarding the MDR is available at the following link:https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

 

Full MRD text is available at the following link:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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