3 docs tagged with "clinical-evaluation"

MDR Art. 61 and Annex XIV. Clinical evaluation is mandatory for all MDR devices regardless of class. It is a continuous, lifecycle process — not a one-time pre-market exercise.

MDR Annex XIV Part A, Section 4. The CER is the written output of the clinical evaluation process. It must be reviewed and updated throughout the device lifecycle and is a mandatory technical documentation element.

MDR Art. 61(4)–(5) and Annex XIV §3. Equivalence is a tool for leveraging existing clinical data from a comparable device in lieu of a new clinical investigation. Its use is significantly more restricted under MDR than under the previous MDD.