Regulatory Authority
European Commission (definition of the regulatory framework) and Competent Authorities of the Member States (market application and market surveillance).
Classification
- MD: Class I, Class IIa, Class IIb, Class III
- IVD: Class A, Class B, Class C, Class D
Quality system
Reference standard for the quality management system: ISO 13485:2016
To be placed on the market in the European Union, all Medical Devices must comply with the applicable requirements and bear the CE marking of conformity. In the case of a non‑EU manufacturer, it is mandatory to designate an Authorized Representative established in the European Union.
- Regulation (EU) 2017/745 (MDR): regulatory framework for Medical Devices (entered into force on 25 May 2017 and fully applicable from 26 May 2021)
- Regulation (EU) 2017/746 (IVDR): regulatory framework for in vitro diagnostic Medical Devices (fully applicable from 26 May 2022)
- Classes IIa, IIb and III: involvement of a notified body is always required for the conformity assessment, as these are medium‑high or high‑risk devices
- Class I “special” (Is, Im, Ir): although formally in Class I, when devices are sterile (Is), have a measuring function (Im), or are reusable surgical instruments (Ir), involvement of a notified body is required, limited to the specific aspects (sterility, measuring function, reusability)
For these devices, the technical documentation must be assessed by a notified body that issues a certificate under the MDR/IVDR; on the basis of that assessment, the manufacturer draws up the EU Declaration of Conformity and affixes the CE marking.
Applicant
Manufacturer or Authorized Representative (European Mandatary).
Time and Costs
Variable depending on the risk class, device complexity, and conformity assessment route.
Validity
Certificates issued by a notified body have a maximum validity of 5 years. On the basis of these certificates, the manufacturer can affix the CE marking.
Documentation language and Labelling
Labelling: instructions for use (IFU) and any user interfaces (UI) must be provided in the official languages required by the Member States in which the device is placed on the market.
Useful information
The official list of Notified Bodies is available in the European Commission’s NANDO (New Approach Notified and Designated Organisations) database.
