MDR CER Writing Fees
In the global context of MDR CER writing medical device manufacturers and their regulatory teams are currently grappling with a sense of confusion and ambiguity in relation to EU MDR Article 61 and the intricacies of crafting and documenting Clinical Evaluation Reports (CERs) following the guidelines outlined in MEDDEV 2.7/1 Revision 4.
Our MDR CER Writing consultants and subject matter experts has invested substantial time and effort in conducting thorough research, which has led to the accumulation of valuable expertise in comprehending the strategies essential for the successful documentation of a clinical evaluation report which satisfies the Notified Body requirements.
Below compare MDR CER writing fees by device risk class (Class I to III). Transparent pricing for Clinical Evaluation Reports. Request a proposal today.
MDR CER Writing Fee Details by Risk Class
| # | Activity | RegularScopes 1–10 | PremiumScopes 1–16 | AssuredScopes 1–18 |
|---|
Special Discounts & Bulk Pricing on MDR CER Projects
Discounts can be combined where all conditions are met.
Discounts can be combined. Manufacturers meeting all three conditions simultaneously benefit from all savings.
- Any reclassification or change in MDR classification rules after CER work has commenced.
- Additional accessories not explicitly listed in the originally agreed CER scope.
- Accessories that increase clinical or technical complexity.
- Rework required due to late, incomplete, or inconsistent inputs from the client.
- Devices with multiple intended purposes or multiple clinical indications.
- Combination products (drug–device or biological device combinations).
- Novel devices or technologies with limited or emerging clinical history.
- Cases where equivalence strategy fails or is rejected by the Notified Body due to insufficient access.
- Accelerated timelines, fast-track reviews, or priority submissions requested by the client.
- Any documents or activities not explicitly mentioned in the approved proposal, quotation, or contract.
Frequently Asked Questions on CER Writing Cost
How much does MDR CER writing cost?
What factors affect CER writing fees?
How long does CER writing take?
Can I get a discount for multiple CER projects?
Yes. I3CGlobal offers structured discounts for manufacturers working on multiple CER projects, and these discounts can be combined where all conditions are met. To find out the best pricing for your specific device portfolio, request a proposal with a statement of work.
What is the difference between Regular, Premium and Assured packages?
- Regular — Core CER writing from literature search to final report.
- Premium — Full CER plus PMS, PSUR and PMCF documentation included.
- Assured — Everything in Premium, plus Notified Body review responses handled until your CER is formally accepted.
Information in this page about MDR Consulting Fees / CE Marking Consultancy Cost with items wise MDR cost breakdown developed and created by Sara Moly on 16th May 2026. Approved by Soio George