Regulatory Authority
European Commission
Classification
Class I, Class IIa, Class IIb, Class III
Class A, B, C, D
Quality system
Complies with standard ISO 13485:2016
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 MDR Regulation (EU) 2017/745 – which entered into force on 25 May 2017 and fully applied on 26 May 2021 – is the regulatory reference for placing Medical Devices on the European market.
The MDR requirements apply to all Medical Devices sold in the EU.
In Vitro Diagnostic Medical Devices refer instead to the IVDR (EU) 2017/746.
For Class I MD the Manufacturer or Authorised Representative declares under its own responsibility that the Medical Device complies with the general safety and performance requirements of Annex I of the MDR.
For sterile devices (ls), for devices with measuring function (lm) and reusable surgical instruments (lr) even if they belong to class I, and for class IIa, class IIb and class III devices, the intervention of a Notified Body (Notified Body) is required. The Declaration of Conformity is therefore not sufficient, but the issuing of an EC certificate by a Notified Body is required.
The list of designated Notified Bodies can be found on Nando (New Approach Notified and Designated Organisations) Information System (https://ec.europa.eu/growth/tools-databases/nando/)
Validity
The CE certificate issued by a Notified Body is valid for 5 years.
Labelling and documentation language
The documentation and labelling must be translated into one of the languages accepted by the Member States where the device is to be marketed.
Useful information
On 6 January 2023, the European Commission issued a proposal to extend the transition period under Art. 120 for MDR until 2027-2028, which was welcomed by the European Parliament on 16 February. The new deadlines depend on the type and risk class of the Medical Devices.
