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 On 26 May 2021, these directives will be repealed by Regulation (EU) no. 2017/745 (MDR) which will become the new regulatory reference for the placing on the market of medical devices.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 will repeal 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.

Annex of the Directive Conformity Assessment procedure EC Certificate
Annex Il Annex II.4 (only for class III devices) Evaluation of the design dossier of the device EC design-examination certificate
Allegato Il escluso punto 4 Evaluation of the full quality assurance system applied to all the phases – design, manufacture and final inspection of the products concerned. The evaluation includes the analysis of the technical documentation of the devices contemplated by the quality system. EC declaration of Conformity (Full Quality Assurance System)
Annex  III Evaluation of the technical documentation of the device and execution of tests on a representative sample of a given production (type examination). EC Type Examination Certificate
Annex  IV Evaluation of the technical documentation of the device and execution of tests on each product of the batch (test on every device)  or on samples (statistical verification). EC Verification Certificate
Annex  V Evaluation of the quality system applied only to the product manufacturing phase. The evaluation includes the analysis of the technical documentation of the devices contemplated by the quality system. Production Quality Assurance System Approval Certificate
Annex  VI Evaluation of the quality system applied only to the final inspection of the product. The evaluation includes the analysis of the technical documentation of the devices contemplated by the quality system. Product Quality Assurance System Approval Certificate


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.

Annex of the Directive Conformity assessment procedure EC Certificate
Annex 2 Annex 2.4 Evaluation of the design dossier of the device EC design-examination certificate
Annex 2 excluding point 4 Evaluation of the full quality assurance system applied to all the phases – design, manufacture and final inspection of the products concerned. The evaluation includes the analysis of the technical documentation of the devices contemplated by the quality system. Full Quality Assurance System Approval Certificate
Annex 3 Evaluation of the technical documentation of the device and execution of tests on a representative sample of a given production (type examination). EC Type Examination Certificate
Annex 4 Evaluation of the technical documentation of the device and execution of tests  with statistical verification. EC Verification Certificate
Annex 5 Evaluation of the quality system applied only to the product manufacturing phase. The evaluation includes the analysis of the technical documentation of the devices contemplated by the quality system Production Quality Assurance System Approval Certificate


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.

 

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