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.
If your organization has genuine interest in the process of either revising an existing MDD Clinical Evaluation Report or initiating the development of a new one, taking into consideration the regulations specified in Article 61, we kindly request that you examine the pricing information provided below, tailored to your specific device class.
MDR Clinical Evaluation Report (CER) Documentation Writing and Ownership Fee Structure by Risk Class
| Clinical Evaluation Activities (Article 61 & Annex XIV) | ||||||
|---|---|---|---|---|---|---|
| Scope # | Activity | |||||
| 1 | Guidance on Clinical Evaluation Route | |||||
| 2 | Development of Procedures & Templates | |||||
| 3 | Clinical Evaluation Scoping | |||||
| 4 | Clinical Evaluation Planning | |||||
| 5 | Identify Literature Source and Scientific Literatures | |||||
| 6 | Literature Search Review & Report | |||||
| 7 | Demonstration for the equivalence device provided by the manufacturer | |||||
| 8 | Appraisal of Clinical Data | |||||
| 9 | Analysis of Clinical Data | |||||
| 10 | Clinical Evaluation Report with Conclusion | |||||
| 11 | Review of Risk Management Files | |||||
| 12 | Review of IFU / User Manual | |||||
| 13 | PMS Documentation based on data provided by the Manufacturer | |||||
| 14 | PMSR/PSUR Documentation based on data provided by the Manufacturer | |||||
| 15 | PMCF Documentation (for Class I, Is, Ir, Im, and IIa) | |||||
| 16 | PMCF Documentation based on the provided PMCF study Data (for Class IIb, Class III, and Implantable) | |||||
| 17 | SSCP (for Class III and Class IIb Implantable only) | |||||
| 18 | Answering to Notified Body review comments till acceptance | |||||
| MDR Device Risk Class | ||||||
| Choose your required service type from below options | Class I | Class I (S/M/R) | Class IIA | Class IIB | Class III | |
| REGULAR (Scope 1 to 10) | $3000 | $5000 | $6000 | $9000 | $11000 | |
| PREMIUM (Scope 1 to 16) | $4000 | $6000 | $9000 | $11000 | $14000 | |
| ASSURED (Scope 1 to 18) | $9000 | $11000 | $14000 | $17000 | ||
🌟 Special Pricing & Smart Savings on MDR CER Projects
⊗ When multiple CER,s are developed under a single TD File, each additional CER is charged at only 50% of the standard fee.
⊗ A 20% bulk discount applies when three (03) or more CER projects are initiated simultaneously
⊗ Enjoy an additional 10% discount when client coordination with our consulting team is excellent and the CER is successfully completed and uploaded to the Notified Body within 4 months.
⚠️ Items Excluded / Subject to Additional Fees
⊗ Any reclassification or change in applicable MDR classification rules after CER work has commenced.
⊗ Additional accessories not explicitly listed in the originally agreed CER scope.
⊗ Rework required due to late, incomplete, or inconsistent inputs from the client.
⊗ Cases where the client insists on an equivalence approach without I3CGlobal consultant alignment and subsequently fails to obtain adequate technical, clinical, or biological access, or where the Notified Body rejects the equivalence strategy, necessitating a new clinical approach
⊗ Accelerated timelines, fast-track reviews, or priority submissions requested by the client.