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.

See the Regulation of Legacy Medical Devices (MDD).

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.