Clinical Evaluation Reports That Satisfy Notified Bodies — First Time
Under EU MDR, clinical data is not optional — it is the cornerstone of device safety proof. MEGACERT's clinical evaluation specialists write systematic, evidence-based CERs that survive Notified Body scrutiny and regulatory audit.
Why Clinical Evaluation Is the MDR's Most Demanding Requirement
The EU MDR has transformed clinical evaluation from a checkbox exercise into a rigorous, science-driven process. Under Article 61 and Annex XIV, manufacturers must demonstrate clinical evidence for their devices — not just equivalent device data — and maintain that evidence through the device's entire lifecycle.
Key MDR changes vs. MDD
- Equivalence claims are now strictly limited and require contractual access to the equivalent device's technical file
- PMCF (Post-Market Clinical Follow-Up) is presumptively required for all implantable and Class III devices
- SSCP must be published on EUDAMED for implantable and Class III devices
- Legacy devices relying on MDD CERs must be upgraded to MDR standard
Our Clinical Evaluation Services
Clinical Evaluation Report (CER)
We write full CERs per MEDDEV 2.7.1 Rev. 4 and MDCG 2020-1 — including clinical background, state-of-the-art review, device-specific clinical data appraisal, equivalence assessment, and clinical conclusions. Every CER includes a Clinical Evaluation Plan (CEP).
Systematic Literature Review
Our team conducts structured database searches (PubMed, Embase, Cochrane) using PICO/PICOS frameworks. We appraise study quality with validated tools (GRADE, SIGN, AMSTAR) and integrate findings into your CER in a manner that withstands Notified Body challenge.
PMCF Plan & Report
Post-Market Clinical Follow-Up is now mandatory for most device classes. We design PMCF plans per MDCG 2020-7 that are proportionate, feasible, and auditable — whether via registry participation, post-market studies, or structured user surveys.
Clinical Investigation Plan (CIP)
When existing clinical data is insufficient, a clinical investigation is required. MEGACERT drafts CIPs per ISO 14155:2020 and supports Ethics Committee submissions, investigator coordination, and data management planning.
Frequently Asked Questions
Don't let clinical data gaps delay your MDR certification. MEGACERT's clinical team is ready to assess your current evidence and chart the fastest compliant path forward.
Book a Clinical Data Assessment