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COVID 19 In Vitro Diagnostic Test Kit CE Marking

COVID 19 In Vitro Diagnostic Tests Kit CE Marking

The European Commission has released guidelines on COVID 19 in vitro diagnostic test Kit CE Marking and their performance, based on which the COVID-19 In Vitro Diagnostic Test Kit could be commercialized in the EU market.
It is stated in the guideline, under EU regulatory context of COVID -19 test devices that, “Directive 98/79/EC on in vitro diagnostic medical devices (IVD) currently applies to COVID-19 tests. In order to place these tests on the EU market, the manufacturer has to comply with the relevant provisions of the Directive.”
“For COVID-19 tests intended for use by health professionals, the CE-mark may be affixed following a declaration by the manufacturer that the requirements of the Directive are satisfied (declaration of conformity).”

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 Antibody detection kit do no fall under List A or B of Annex II of IVDD.  According to IVDD, Article 9 – Conformity assessment procedure, For all devices “other than” those covered by Annex II (List A and List B) and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and  draw up the EC declaration of conformity required before placing the devices on the market.

Covid 19 IVD Kit CE Marking Process

Step I : Develop IVDD Technical File

Manufacturer should be responsible to keep final and updated IVDD Technical File and submit to your European Authorized Representative  (Only for Non Eu Manufactures)

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.