Directives 93/42/EEC and 90/385/EEC: CE 0051 certification to commercialise medical devices and active implantable medical devices in Europe

Medical devices can be placed on the market or put into service only if they meet the requirements of directive 93/42 / CCE  and of the directive 90/385 / EEC and as amended which are intended to ensure the safety and health protection of patients, users and any third parties during the use of these products. On 26 May 2021, these directives have been repealed by Regulation (EU) no. 2017/745 (MDR) which has become the new regulatory reference for the placing on the market of medical devices.

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IMQ is Notified Body for the Regulation (EU) No. 2017/745 on medical devices that on 26 May 2021 has repealed Directive 93/42 /EEC and Directive 90/385/EEC 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 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.

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

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 on the right.

 
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.

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 90/385/CEE as amended” available in the “download” section herein on the right.