- EU MDR Compliance Experts
Clinical Evaluation & Post-Market Surveillance Under EU MDR
Our Clinical Services
Comprehensive EU MDR PMS Support
From clinical evaluation strategy through post-market reporting, our services ensure your documentation meets the stringent requirements of EU MDR and Notified Body expectations.
A. Clinical Evaluation Report (CER) Development & Updates
We support the drafting, updating, and remediation of Clinical Evaluation Reports in line with EU MDR requirements and MEDDEV 2.7/1 Rev.4. The CER is the cornerstone of your technical documentation — synthesizing all available clinical data to demonstrate the safety and performance of your device.
Key Activities & Deliverables
- Systematic screening and critical appraisal of relevant clinical and scientific data
- State-of-the-Art (SOTA) and background evidence synthesis
- Integration of clinical investigation findings and manufacturer-held data
- Drafting and updating of CERs and supporting clinical documentation
- Gap analysis, remediation, and re-alignment of existing CERs for Notified Body submission
- Periodic CER updates incorporating latest clinical data, PMCF findings, and vigilance trends
- Support for SSCP (Summary of Safety and Clinical Performance) development
B. Clinical Evaluation Plan (CEP) Development & Updates
A robust CEP is the foundation of a defensible clinical evaluation under MDR. It defines the scope, appraisal criteria, equivalence pathway, and clinical data requirements for demonstrating safety and performance.
Key Activities & Deliverables
- CEP strategy definition aligned to device risk class, intended purpose, and clinical claims
- Authoring and customization of CEPs to reflect device-specific clinical needs
- Equivalence pathway analysis and justification documentation (technical, biological, clinical)
- Gap assessment of existing clinical and technical documentation
- Revision, updating, and remediation of CEPs to ensure compliance and audit readiness
- Alignment of CEP with risk management file, IFU, and SSCP requirements
C. Clinical & Scientific Literature Review
We conduct structured, MDR-aligned literature reviews to support clinical evaluations and regulatory submissions. Our searches are systematic, reproducible, and transparent — meeting MEDDEV 2.7/1 Rev.4 and MDCG expectations.
Key Activities & Deliverables
- State-of-the-Art (SOTA) and background evidence mapping
- Systematic identification of relevant clinical investigation literature
- Design and execution of literature search strategies aligned with MDR expectations
- Database searches across PubMed, Embase, Cochrane, and specialty databases
- Gap analysis of existing clinical and non-clinical evidence
- Review of pre-clinical and non-clinical data
- Periodic literature update searches for CER maintenance and PMCF planning
D. PMSR / PSUR Support
We support manufacturers in developing and maintaining Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) as required under MDR Articles 85 and 86 — ensuring alignment with CER conclusions and risk management outputs.
Key Activities & Deliverables
- Structuring PMSR and PSUR documentation aligned with regulatory expectations
- Integration of complaint data, vigilance data, and trend analysis
- Alignment with CER conclusions, risk management, and performance claims
- Support for surveillance cycles and Notified Body review readiness
- Support for PMCF (Post-Market Clinical Follow-up) planning and data integration
- Coordination with risk management and quality teams for closed-loop corrective actions
Why SORA LIFESCIENCES
Built for Regulatory Excellence
Regulatory-First Approach
Every deliverable is built to withstand Notified Body scrutiny. We build defensible clinical evidence packages — not just documents.
Deep Domain Expertise
Our team includes regulatory affairs specialists, clinical scientists, and medical writers with direct MedTech industry and NB experience.
End-to-End Capability
From gap analysis and strategy through authoring and submission support — we cover the full clinical evidence lifecycle under EU MDR.
Audit-Ready Deliverables
Documentation structured for seamless NB review, reducing deficiency letters and accelerating your path to CE marking.
200+
CERs Delivered
50+
Device Classes Covered
15+
Years Industry Experience
98%
First-Time NB Acceptance