Marketing of a Medical Device in Europe
Marketing of a Medical Device in Europe
The information included in this document are valid and current from June 2020. Legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they relate. In view of that, the writer declines all responsibilities with regard to any lack of relevance and/or accuracy of information occurred at or after the publication of this page.
Regulatory Authority:
European Commission.
Classification:
Class I, Class IIa, Class IIb, Class III.
Quality System:
Complies with ISO 13485:2016.
Procedure/process:
To be marked in Europe, all medical devices must bear the CE marking.
In the case of a non-European Manufacturer, it is necessary to appoint a European Authorized Representative.
The current reference legislations are the Directive 93/42/EEC (MDD) and subsequent changes concerning medical devices and the Directive 90/385/CEE and subsequent changes relating to active implantable medical devices.
For the class I MD, the Manufacturer or the Authorised Representative declares under his own responsibility the compliance of the medical device with the essential requirements of the Annex I of the MDD.
For sterile devices, for devices with a measuring function, even if they belong to class I, and for the class IIa, class IIb and class III devices, the intervention of a Notified Body (NB) is necessary. The Declaration of Conformity is therefore not enough, but an EC certificate must be issued by a NB.
The designated NB list is available on Nando (New Approach Notified and Designated Organisations) Information System
