- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Regulation (EU) 2017/745 on medical devices; hereinafter: MDR).
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Regulation (EU) 2017/746 on in vitro diagnostic medical devices; hereinafter: IVDR).
As of 26 November 2017, conformity assessment bodies may apply for designation as notified bodies to a competent authority under the conditions set out in the above-mentioned regulations (see more under: Designation procedure).
The requirements for the designation of a conformity assessment body as a notified body for medical devices are set out in Annex VII of the MDR and Annex VII of the IVDR.
- organisational and general requirements;
- quality management requirements;
- resource requirements;
- process requirements;
In line with the requirements of the MDR and IVDR and considering the timeline of the designation procedure, it is estimated that a minimum of 18 months is needed to complete the whole process before a notified body can begin performing assessment and certification procedures for medical devices.