Notified body

In May 2017, two new regulations relating to medical devices came into force, namely:
  • 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.

They are divided into four categories:
  • 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.

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