Clinical Evaluation Report Expertise and Support
EU MDR Clinical Evaluation Report (CER) writing, literature review, and clinical evidence consulting for medical device manufacturers.
CiteMed’s team includes experienced regulatory writers, medical researchers, and systematic literature review specialists who support medical device manufacturers with EU MDR Clinical Evaluation Reports (CERs). We work closely with regulatory and clinical teams to develop CERs that align with MDR Annex XIV requirements, combining rigorous literature review methodology with clear regulatory writing.
In addition to CER writing, our team provides clinical evidence consulting and literature review support to help manufacturers strengthen their regulatory strategy. Whether you need full CER preparation, literature review development, or expert guidance during notified body review, CiteMed helps ensure Clinical Evaluation Reports are structured, defensible, and ready for submission.
A CER Process
That Fits Your Team
Work With Us On Your Terms
Have some great writing staff already? Or limited budget? Plug directly into our process and use our expertise only when you need it.
Full CERs End to End
Our team of Notified Body Acceptable CER writers can deliver a complete document ready for submission.
Use Our Templates
Draft your new MDR CER from our templates. Complete training annotations. and Notified Body insights included.
CER writing that gets approved.
MDR-compliant clinical evaluation reports written by experienced regulatory professionals. A dedicated writer, a clear timeline, and audit defense included — from kickoff through certificate.
“How long will this take?”
8–12 weeks standard delivery. 5–6 weeks rush. Literature review completes in 2–4 weeks. We’re 3–4x faster than big consulting firms.
“Do you have experience with my device type?”
100+ device types across all EU classes — Class I through III, IVDs, SaMD, drug-device combos. We match you with a writer who already knows your space.
“Will it pass the audit?”
100% acceptance rate. No audit passes on the first round — we stay through the entire cycle of NB feedback until your certificate is issued.
“Who’s writing it?”
Regulatory writers with 12–30+ years experience, advanced clinical/scientific degrees, and CVs provided with every submission per MDR requirements.
We deliver in weeks, not quarters.
Our refined startup process and dedicated writer model eliminates the overhead that slows down traditional consulting engagements. Standard CER delivery in 8–12 weeks. Rush in 5–6.
Weeks
Wk 2
Wk 4
Wk 6
Wk 8
Wk 10
Wk 12
Wk 14
Wk 16
We don’t hand you a document and disappear.
Most CER providers deliver a PDF and wish you luck. We stay through your entire notified body audit process — because no audit is successful on the first round.
Every CER engagement includes full audit defense support. When your notified body comes back with questions, findings, or requests for additional information — we’re in the room with you.
This is why we can say 100% acceptance rate with integrity. We don’t count a CER as complete when we deliver the first draft. We count it when your certificate is issued.
Full-service, or support when you need it.
Whether you need a qualified writer for the entire process, or extra capacity to accelerate productivity within your existing team — our approach supports both.
For smaller manufacturers
Full-Service CER
We own the entire process end-to-end — literature review, writing, revisions, and final deliverable. You get an audit-ready CER without building an internal team.
For larger manufacturers
Staff Augmentation
Already have a regulatory team and process? We plug in where you need capacity — an experienced writer who works within your existing workflows and templates
Trusted across major notified bodies.
Our CERs have been reviewed, accepted, and certified by the notified bodies your submissions go through.
BSI
TÜV Rheinland
TÜV SÜD
BSI
NSAI
100+ device types. All EU classes.
We don’t learn on your project. Our writers have authored CERs across the full spectrum of medical device classifications.
Class III
10+ devices
Aortic stent grafts
Orthopedic joint replacements
ECMO oxygenators
Interarterial shunts
Orthopedic bone grafts
Drug-device combos
Wound closure systems
CamAPS FX (SaMD)
IVD
Class C
P63 Antibodies
Diagnostic assays
+ FDA
510(k) submissions
FDA compliance support
Writers that get it done.
Regulatory professionals with CVs attached to every submission.
Every CER is authored by a writer with direct medical device regulatory experience. They know what notified bodies look for because they’ve been through the process — repeatedly.
In accordance with MDR, MEDDEV 2.7/1 Rev 4, and MDCG guidance, your evaluator’s CV and COI declaration are provided with every submission.
We maintain a staff of approximately 10 dedicated regulatory writers. All work is completed and approved by our Directors.
Edward J., M.S.
Director
30+ years clinical experience
15+ CERs personally authored
Drug and medical device experience. MDR project oversight for 3+ years. Meets and exceeds all criteria for MDR Clinical Evaluator.
Senthil K.
12+ years med device experience
SME in Clinical Evaluations and EU MDR. All device classes. Skilled in CER, PMS Plan, PSUR, PMCF Plan & Report, SVR, and CPR.
Edward J., M.S.
Regulatory Affairs Specialist
MDR & IVDR specialist
Quality and Regulatory Affairs for medical devices and medicinal products. MDR 2017/745, IVDR 2017/746, FDA 21 CFR 820, 510(k).
How it works.
A clear, repeatable process from kickoff to completion. Weekly status reports, defined milestones, no ambiguity.
Phase 0
Week 1–1.5
Your Content Goes Here
- Dedicated writer + PM assigned
- Kickoff workshop with your stakeholders
- Documentation transfer & intake form
- Project plan and timeline finalized
- Writer reviews device documentation and conducts background research
Phase 1
Weeks 1.5–3
Writing & Draft Delivery
- Literature search performed (or existing search validated)
- Clinical data collected and appraised
- CER drafted against proven template
- Weekly update reports with timeline and risk analysis
- First drafts delivered for all assigned reports
Phase 2
Weeks 3–4+
Revisions & Completion
- Your team reviews and provides comment-based feedback
- Writer incorporates revisions
- Final QA check and formatting review
- Sign-off and formal document handoff
- Audit defense support begins when NB review starts
Beyond The Initial Submission
Your CER doesn’t end at submission.
MDR requires ongoing updates to your clinical evaluation. Manage literature monitoring, post-market surveillance, PMCF, and PSURs in Evidence Cloud™ — or let our team handle the updates for you.
Need broader regulatory support? Explore our full EU MDR & IVDR consulting services for gap assessments, submission support, and end-to-end compliance consulting
Literature
Ongoing monitoring & updates
Vigilance
PMS, PMCF & PSUR reports
ReadyView
Submission-ready exports