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).

Conformity assessment bodies can since November 26, 2017, submit an application for designation to the competent authority under the conditions set out in the above-mentioned regulations (see more under: Procedure for designation).

After designation and notification, the notified body can submit an application to the competent authority for extending the scope of the designation (see more under: Procedure for extending the scope of the designation) or prior requested by the competent authority to submit an application for complete re-assessment of the notified body (more under: Procedure for complete re-assessment).

The requirements for:

  • the designation of a conformity assessment body as a notified body for medical devices,
  • for extension of the scope of the designation of the notified body and
  • complete re-assessment of the notified body

are set out in Annex VII of the MDR and Annex VII of the IVDR and are divided into four categories:

  • organisational and general requirements,
  • quality management requirements,
  • resource requirements and
  • process requirements.

In line with the requirements of the MDR and IVDR and considering the timeline of the designation and notification process, it is estimated that a minimum of 18 months is needed to complete the whole process. Only after the designation and notification is complete, the notified body can begin performing assessment and certification procedures for medical devices.

Scroll to Top