Calculate Technical Documentation and Consultation Cost[Cost calculated per technical documentation]Please enable JavaScript in your browser to complete this form. - Step 1 of 2MDR Documentation Fee EstimateMedical Device ClassII s/m/rIIaIIbIIINumber of Models123<5<10Difference in design and intended use not considered under models.Number of variants01-56-1011-1516-20SterilisationNoYesETO, GAMMA, STEAMSoftwareNot IntegratedIntegratedFirmware / SIMDNano ParticlesYesNoAnimal derivatives / materials usedNoYesType of ImpalntsNoPartial ImplantsImplantsAccessoriesNIL2-45-9Support, supplement, and/or augment the performance of main device.ConsumablesNil2-45-9Is the device used at Home?NoYesDoes the device include Drug?NADrug Device Combination (NBoP)Ancillary Medicinal DeviceTotal SummaryNameTotal ($)Medical Device ClassII s/m/rIIaIIbIIIII s/m/r IIaIIbIIINumber of Models123<5<10123<5<10Number of variants01-56-1011-1516-201-56-1011-1516-20SterilisationNoYesNoYesSoftwareNot IntegratedIntegratedNot IntegratedIntegratedNano ParticlesYesNoYesNoAnimal derivatives / materials usedNoYesNoYesType of ImpalntsNoPartial ImplantsImplantsNoPartial ImplantsImplantsAccessoriesNIL2-45-9NIL2-45-9ConsumablesNil2-45-9Nil2-45-9Is the device used at Home?NoYesNoYesDoes the device include Drug?NADrug Device Combination (NBoP)Ancillary Medicinal DeviceNADrug Device Combination (NBoP)Ancillary Medicinal DeviceTotal ($)TotalNextName *Email *Phone *PreviousSend EmailEU Authorized Representative Fee CalculatorMDR 2017/745 Notified Body Fee CalculatorBiocompatibility Testing Cost CalculatorMDR 2017/745 - Back to Pricing Page
