MDR 2017/745, Annex IX and IVDR 2017/746, Annex IX. Annex IX is the most widely used conformity assessment route for Class IIa, IIb, III (MDR) and Class B, C, D (IVDR). It is the only permitted route for Class III (MDR) and Class D (IVDR).
MDR 2017/745, Annex X and IVDR 2017/746, Annex X. Annex X defines the EU type examination procedure. It is used in combination with Annex XI (Part A or B) and is available for Class IIa, IIb (MDR) and Class B, C (IVDR). Not available for Class III (MDR) or Class D (IVDR), which must use Annex IX.
MDR Art. 52(7) and Annex IV. Class I devices (standard) do not require notified body involvement. The manufacturer self-declares conformity by signing an EU Declaration of Conformity after completing all required steps.
MDR conformity assessment procedures are set out in MDR Art. 52 and Annexes IX–XI. IVDR equivalents are in IVDR Art. 48 and Annexes IX–XI. The EU Declaration of Conformity is required under MDR Art. 19 / IVDR Art. 17 and MDR Annex IV / IVDR Annex IV.
MDR Art. 19 and Annex IV (Declaration of Conformity); MDR Art. 20 (CE marking). Equivalent IVDR provisions: Art. 17 and Annex IV (DoC); Art. 18 (CE marking).
This site provides general information only and does not constitute legal or regulatory advice.
Notified body obligations are set out in MDR Art. 36–50 and Annex VII / IVDR Art. 33–47 and Annex VII. Notified bodies are designated by national competent authorities and supervised by the MDCG.