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CE Certification Cost (Medical Devices)

New MDR! Confused? How much a new Medical Device CE Certification will cost!

Check out our estimated pricing below for CE Certification Cost of Medical Devices.  Our estimates are almost correct and we do not bill you extra for any additional effort. This is our promise. We will not ditch you halfway! Contact us today.

CE certification cost

MDR & IVDR Tentative CE Certification Cost (Fees)

Below are I3CGLOBAL’s tentative CE Certification Cost for various class. You may need to take our final proposal after considering all variants and Intended use.

 

Cost of CE Marking depends on a number of technical files, Device Class, Intended use, constructional material & technology.

CLASS I

Regular

Premium

Assured

1

Development of Technical File

O

O

2

Development of Declaration of Conformity (DOC)

3

Label Review

O

4

Biological Evaluation (Testing not Included)

O

O

5

Risk Analysis Documentation

O

O

6

Clinical Evaluation

O

O

7

PMS

O

O

$ 850

$1550

$7500

8European Authorized Representative

$ 700 / Year

9Third Part Compliance Certificate

$ 600 / Year

10EU Registration

$ 200

11EU Registration Certificate (Issued by EAR)

$ 300

CLASS Is/m/r & CLASS IIa

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

4

Biological Evaluation

5

Risk Benefit Documentation

O

7

Clinical Evaluation Documentation

O

8

PMS + PMCF + PSUR Documentation

O

9

European Authorized Representative

O

9

Notified Body Coordination till CE Granting

O

O

$ 3000

$9000

$11000

10European Authorized Representative

$ 950 / Year

11EU Registration

$ 200

12Medical Device Testing

Request for Quote

13Sterilizer Validation / Process Validation

Request for Quote

14Clinical Evaluator (Doctor)

Request for Quote

15Notified Body Fees / Technical File (reference purpose only)

15500 Euros

CLASS IIb

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

4

Biological Evaluation

5

Risk Benefit Documentation

O

7

Clinical Evaluation Documentation

O

8

PMS + PMCF + PSUR Documentation

O

9

Notified Body Coordination till CE granting

O

O

$ 4000

$11000

$14000

10European Authorized Representative

$ 1100 / Year

11EU Registration

$ 200

12Medical Device Testing

Request for Quote

13Sterilizer Validation / Process Validation

Request for Quote

14Clinical Evaluator (Doctor)

Request for Quote

15Accessories to Active device above 3 Nos.

$ 1000 / accessories

16Notified Body Fees / Technical File (reference purpose only).

18500 Euros

CLASS III

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

4

Biological Evaluation

5

Risk Benefit Documentation

O

7

Clinical Evaluation Documentation

O

8

PMS + PMCF + PSUR Documentation

O

9

Notified Body Coordination till CE granting

O

O

$ 5000

$14000

$17000

10European Authorized Representative

$ 1300 / Year

11EU Registration

$ 200

12Medical Device Testing

Request for Quote

13Sterilizer Validation / Process Validation

Request for Quote

14Clinical Evaluator (Doctor)

Request for Quote

15Ancillary Medicinal Substance if…

$6000 additional

16Accessories to Active device above 3 Nos.

$ 1000 / accessories

17Notified Body Fees / Technical File (reference purpose only).

21500 Euros

Note:

  • Price quoted per Intended use / technical File / construction /design.
  • Additional technical File 25% discounted
  • Consultant travel to client location for emergency will be charged for airline travel & accommodation for a maximum of 3 man-days.

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