Annex XIV — Clinical Evaluation

Source: EU MDR 2017/745 Annex XIV | OJ L 117, 5.5.2017

Part A — Clinical Evaluation

Clinical Evaluation Requirements (Article 61)

Manufacturers shall conduct a clinical evaluation to confirm that:

• The device conforms to the relevant requirements of Annex I GSPR
• The intended benefits of the device outweigh the risks

Clinical Evaluation Pathways

Pathway 1 — Clinical Data (preferred):

• Clinical investigation data from the manufacturer's own device
• Literature review (scientific literature search)
• Clinical data from an equivalent device (equivalence must be demonstrated)

Pathway 2 — Equivalent Device:

• Technical, biological and clinical equivalence with the equivalent device must be demonstrated
• For Class III and implantable devices, a contract with the equivalent device manufacturer must be in place to obtain access to technical documentation

Clinical Evaluation Report (CER) Content

1. Scope definition: device description, intended purpose, target patient population
2. Clinical background: clinical context of the disease/condition, existing treatment options
3. Literature search strategy: databases searched, keywords, inclusion/exclusion criteria
4. Literature appraisal: literature quality assessment, data extraction
5. Clinical data analysis: safety and performance data summary
6. GSPR conformity: support of clinical data for GSPR
7. Benefit-risk analysis: benefit-risk assessment based on clinical data
8. Conclusions: clinical evaluation conclusions
9. Reference to PMCF plan

Clinical Evaluation Updates

• CER shall be updated periodically (at minimum in sync with PSUR)
• For Class III and implantable devices: the notified body shall review the CER

Part B — Post-Market Clinical Follow-up (PMCF)

PMCF Plan Content

• General objectives and rationale for PMCF activities
• Specific methods and procedures (PMCF studies, questionnaires, literature reviews, etc.)
• Reference to relevant harmonised standards (EN ISO 14155)
• Timeline

PMCF Report

• PMCF report shall be incorporated into CER updates
• Shall describe the results of PMCF activities and their impact on CER conclusions

Related Pages

• Annex I — GSPR
• Annex II — Technical Documentation
• Annex III — Technical Documentation on PMS
• Harmonised Standards — Clinical Investigation

Official Sources

• EUR-Lex: EU MDR 2017/745 full text (including Annex XIV)
• MDCG 2020-5: Guidance on clinical evaluation
• MDCG 2020-6: Guidance on PMCF