Who is concerned?

Manufacturing or placing on the market medical devices falling within the following classes:
Class I sterile;
Class I with a measuring function;
Class IIa;
Class IIb.


EU Directive 93/42/EEC, transposed into Italian law by Italian Legislative Decree no. 46  dated 24.02.1997, as amended, lays down the conditions under which medical devices may be placed on the market, with the aim of ensuring the protection of health and safety of patients, users and any third party when using such products. Medical Devices are a broad category of products (instruments, apparatus, implants, materials, software, etc.) intended to be used for or on human beings for the purpose of diagnosis, prevention, monitoring or treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, or control of conception. Such medical device must not achieve its principal intended action through pharmacological, immunological or metabolic means, but may be assisted in its function by such means (ancillary action). The intended use of the product must serve a medical purpose. 


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Certiquality, as a Notified Body (n: 0546) according to the terms of EU Directive 93/42/EEC, performs the relevant verification operations for the release of CE certification of medical devices in classes I sterile, I with a measuring function, IIa and IIb pursuant to:
Annex II (Full Quality Assurance System);
Annex V (Production Quality Assurance); 
Annex VI (Product Quality Assurance) of the Directive.
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The Certification Process

The certification process involves the following steps:

  • The Manufacturer lodges a certification application with Certiquality (Notified Body);
  • Certiquality examines the technical documentation of the medical device and assesses the clinical evaluation prepared by the manufacturer;
  • Certiquality conducts an inspection at the manufacturer’s offices and production sites and, if necessary, on the premises of the manufacturer’s key suppliers;
  • Certiquality issues an EC certificate for the medical device following its successful assessment, which is valid for five years;
  • During the validity period of the certificate, Certiquality carries out surveillance inspections and at the end of such validity period, a renewal inspection.


To ensure that medical devices are placed on the market in the proper manner, the manufacturer has the following responsibilities:

Proper classification of the medical device. 
The class of the product depends on its intended purpose. EU Directive 93/42/EEC provides that medical devices are grouped into four product classes: Class I (including devices in sterile condition or with a measuring function), Class IIa, Class IIb and Class III, depending on their complexity and on the potential risk to the patient, user or any third party. 

Demonstration of compliance with the essential requirements of EU Directive 93/42/EEC. 
In order to demonstrate that the device complies with the essential requirements of the directive, the manufacturer must provide adequate documentation (the Technical Documentation) describing the medical device and the processes used it its design, manufacture and placement on the market.

Attestation of conformity and CE marking of the medical device. 
The attestation of the conformity of the medical device is made by the manufacturer when issuing the Declaration of Conformity.
For medical devices of any class above Class I and for certain products placed on the market in sterile condition and devices with a measuring function, prior to attesting to the conformity of the product, the manufacturer must initiate a conformity assessment procedure with the intervention of an independent third party, the Notified Body.

The Technical Documentation of the medical device consists of a set of documents drafted under the responsibility of the manufacturer, notwithstanding the partial or total outsourcing of resources at the design or production stage, to demonstrate the conformity of the medical device to the requirements of EU Directive 93/42/EEC, including the applicable Essential Requirements set out in its Appendix I.

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