Medical devices must undergo a conformity assessment in the EU, EEA and Switzerland in accordance with EU MDR 2017/745. This assessment must demonstrate that the medical device meets the “Essential Safety and Performance Requirements according to EU MDR 2017/745 Annex I.
In the case of risk class I, an own conformity assessment is sufficient and in the case of risk classes Is/Im/Ir, IIa/b and III, a “Notified Body” must be involved, which then performs a conformity assessment and issues a certificate of conformity (CE certificate).
This conformity assessment requires extensive technical documentation in accordance with EU MDR 2017/745 Annex II and III.
We can support you in the preparation of the technical documentation and the conformity assessment.