The Clinical Evaluation Report (CER) is a key requirement for CE Marking under EU MDR 2017/745. Accuprec’s Regulatory Affairs team specializes in preparing CERs that comply with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV, combining scientific literature, clinical data and performance evidence.

Our CER Development Process:

• Clinical Literature Review: Comprehensive data retrieval and evaluation using PubMed, Embase and other indexed databases.
• Clinical Data Evaluation: Assessment of preclinical, clinical and post-market data.
• Equivalence Assessment: Comparison of your device with predicate devices using structured equivalence tables.
• Risk–Benefit Analysis: Systematic evaluation of safety and performance outcomes.
• Gap Analysis & PMS Integration: Updating CERs with post-market surveillance and vigilance data.

Why Choose Accuprec

• Expertise in EU MDR technical documentation and notified body feedback handling.
• Multi-disciplinary CER team combining clinicians, toxicologists and regulatory experts.
• Support for initial submissions, renewals and periodic CER updates.

Outcome: Regulator-ready CERs ensuring compliance, traceability and market access in the EU region.