7 docs tagged with "clinical-evidence"

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. 62–82 and Annex XV. Clinical investigations — structured studies in human subjects — are the gold standard for clinical evidence. They are mandatory for certain device classes and may be required when existing evidence is insufficient.

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.

IVDR Art. 56 and Annex XIII. Performance evaluation for IVDs is the IVDR equivalent of clinical evaluation under MDR. It is mandatory for all IVD classes and must be maintained as a continuous lifecycle process.

IVDR Art. 57–77 and Annex XIV. Performance studies are studies conducted on specimens from human subjects specifically to evaluate the performance of an IVD. They have their own regulatory framework distinct from MDR clinical investigations.

Both MDR 2017/745 and IVDR 2017/746. International clinical data — generated outside the EU — can be used in clinical evaluations and performance evaluations, subject to certain conditions.