Calculate MDR CER Writing Cost [Cost calculated per technical documentation] Please enable JavaScript in your browser to complete this form. - Step 1 of 2CER Writing Fee Calculator Medical Device ClassII s/m/rIIaIIbIIINumber of Models12345Difference in design and intended use not considered under modelsNumber of variants01-56-1011-1516-20Under each Models mentioned aboveSterilisationNot ApplicableYes, SterilizedETO, GAMMA, STEAMSoftwareNot IntegratedIntegratedFirmware / SIMDNano ParticlesNoYesAnimal derivatives / materials usedNoYesThe device is an Implant?NoYesAccessoriesNIL2-45-9support, supplement, and/or augment the performance of main deviceIs the device used at Home?NoYesDoes the device include Drug?NADrug Device Combination (NBoP)Ancillary Medicinal DeviceService Interested from I3CGLOBAL?CER OnlyCER with NB Coordination till ApprovalTotal Summary Name Total ($) Medical Device Class I I s/m/r IIa IIb III II s/m/rIIaIIbIIINumber of Models 1 2 3 4 5 12345Number of variants 0 1-5 6-10 11-15 16-20 1-56-1011-1516-20Sterilisation Not Applicable Yes, Sterilized Not ApplicableYes, SterilizedSoftware Not Integrated Integrated Not IntegratedIntegratedNano Particles No Yes NoYesAnimal derivatives / materials used No Yes NoYesThe device is an Implant? No Yes NoYesAccessories NIL 2-4 5-9 NIL2-45-9Is the device used at Home? No Yes NoYesDoes the device include Drug? NA Drug Device Combination (NBoP) Ancillary Medicinal Device NADrug Device Combination (NBoP)Ancillary Medicinal DeviceService Interested from I3CGLOBAL? CER Only CER with NB Coordination till Approval CER OnlyCER with NB Coordination till ApprovalTotal ($) TotalNextName *Email *Phone *PreviousSend Email OUR CER PRICINGTECHNICAL DOCUMENTATION FEEMORE ABOUT CLINICAL EVALUATION
