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 to support the clinical evaluation and potentially reduce the need for new clinical investigations. However, equivalence does not eliminate clinical evaluation requirements. Its use is significantly more restricted under MDR than under the previous MDD, particularly for Class III and implantable devices.