COVID 19 In Vitro Diagnostic Tests Kit CE Marking
In Vitro Diagnostic Kits (IVD Kits)
IVD kits are set of components packaged together and intended to be used for, or part thereof, for a specific in vitro diagnostic examination.
Covid-19 antibody detection kit is intended for the detection of 2019-Novel Coronavirus antibody in serum of patients or suspected cases.
Covid 19 IVD Kit CE Marking Process
Step I : Develop IVDD Technical File
Step 2 : Mutually Sign E.A.R Agreement
Non European manufacturers must appoint European Authorized Representative. This is mandatory by law. EAR Address and Contact information must be kept on the primary labels and IFUs
Step 3 : Sign Declaration of Conformity (DOC)
Declaration of Conformity (DOC) must be signed by the most responsible personnel of the company in an official company letterhead with the date of declaration.
More about Declaration of Conformity (DOC)
Step 4: Register the device with EU
The EU Registration process will be completed by the Authorized European Representative of your firm.
IVD Kit CE Marking & EU Registration cost & Timeline
Main Service Fess and Timeline
- Annual EU Representative Service Fees : 1050 Euros (3-4 Working Days)
- EU Registration Fees : 200 / Device (6-10 working days)
Additional / Optional Service Fess and Timeline
- Technical File preparation : 4500 Euros in 60 days time
- Declaration of Conformity (DOC) drafting : 250 Euros in 3 working days
- CE Compliance Certificate : 650 Euros in 2 working days post submission of Technical File.