Medical Devices Directive 1993/42 / EEC

NB: As from 26 May 2021, the notified body is no longer able to issue new certificates under Directive 93/42/EEC, but only allowed to carry out surveillance activities for certificates validity issued under the Directive in the transitional period, as established in Article 120 of Regulation (EU) 2017/745. For more information on Article 120 click here

To communicate changes to legacy devices, it is possible to download and fill in the following form Communication of changes to legacy devices.

Ente Certificazione Macchine is a Notified Body authorized by the European Commission to issue EC Certificates in accordance with Directive 93/42/EEC (MDD). [See the ECM accreditations on the European Commission Database Nando Information System qui]

See the Authorization issued by the Ministry.

The CE mark The CE mark is the mandatory certification mark that every medical device must possess in order to be marketed and used within the European Union. The CE mark declares that the product complies with the applicable European directives. The Medical Device Directive 93/42/EEC (MDD) lists the essential safety, efficacy and quality requirements that a medical device must meet in order to be CE marked and placed on the European market.

Definition and Classification of medical devices

A medical device is defined as any instrument, apparatus, implant, substance or other product, intended by the manufacturer to be used on humans in order to diagnose, prevent, monitor or treat a disease, injury or handicap, provided that the main action is not exercised by pharmacological or immunological means, or by metabolic process, but assisted by such means (for the full definition see the Legislative Decree 46/97).

Since the definition of medical device includes a wide range of more or less complex products, the applicable standards are multiple and depend on the classification and intended use of the device.

To determine the risk class of the device, it is necessary to consult the classification rules of Annex IX of the Directive. Medical devices are classified into

  • Class I devices (which may also be “sterile” or “measuring”)
  • Class IIa and IIb devices,
  • Class III devices.

Class I devices that are not sterile or with measuring function do not require the intervention of a Notified Body, may be self-certified by the manufacturer. Class I-s, I-m, IIa, IIb and Class III devices require the approval of the Notified Body.

ECM is Notified Body for devices I-s, I-m, IIa, IIb.

ECM Services

Obtaining the CE mark involves a series of activities required from the manufacturer to demonstrate the compliance of his device with the requirements of Directive 93/42/EEC.

ECM Medical Device Division is a team of experts in testing, regulatory assessment and quality auditing, able to perform the entire CE certification process.

ECM provides the following services to the medical device market:

  • CE Certification process, composed of 3 phases:
PHASE 1PHASE 2PHASE 3
Review of the technical documentationVerification of ISO 13485 Quality Management SystemOnce the requirements of the Directive have been met, issue of the CE Certificate
  • Audit and Certification of the Quality Management System according to the ISO 13485 standard;
  • Testing Services as ISO 17025 accredited Testing Laboratory

The new Regulation MDR 2017/745

Regarding the incoming of the new Medical Devices Regulation MDR 2017/745 applicable from May 2021, we are pleased to announce that ECM is proceeding with the accreditation process as a Notified Body and hopes to achieve the goal of designation at the soonest.

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