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CE Certification Cost

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

Check out our estimated pricing below for the 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 is I3CGLOBAL’s tentative CE Certification Cost for various classes. 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-Party 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

3

Biological Evaluation

4

Risk Benefit Documentation

O

5

Clinical Evaluation Documentation

O

6

PMS + PMCF + PSUR Documentation

O

7

Application processing with Notified Bodies

O

8

Notified Body Coordination till CE Granting

O

O

$ 3000

$9000

$12000

9European Authorized Representative

$ 950 / Year

10EU Registration

$ 500

11Medical Device Testing

Request for Quote

12Sterilizer Validation / Process Validation

Request for Quote

13Clinical Evaluator (Doctor)

Request for Quote

14Notified Body Fees / Technical File (reference purpose only)

15500 Euros

CLASS IIb

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

3

Biological Evaluation

4

Risk-Benefit Documentation

O

5

Clinical Evaluation Documentation

O

6

PMS + PMCF + PSUR Documentation

O

7

Notified Body Coordination till CE granting

O

O

$ 4000

$11000

$14000

8European Authorized Representative

$ 1100 / Year

9EU Registration

$ 500

10Medical Device Testing

Request for Quote

11Sterilizer Validation / Process Validation

Request for Quote

12Clinical Evaluator (Doctor)

Request for Quote

13Accessories to Active device above 3 Nos.

$ 1000 / accessories

14Notified Body Fees / Technical File (reference purpose only).

18500 Euros

CLASS III

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

3

Biological Evaluation

4

Risk-Benefit Documentation

O

5

Clinical Evaluation Documentation

O

6

PMS + PMCF + PSUR Documentation

O

7

Notified Body Coordination till CE granting

O

O

$ 5000

$14000

$17000

8European Authorized Representative

$ 1300 / Year

9EU Registration

$ 500

10Medical Device Testing

Request for Quote

11Sterilizer Validation / Process Validation

Request for Quote

12Clinical Evaluator (Doctor)

Request for Quote

13Ancillary Medicinal Substance if…

$6000 additional

14Accessories to Active device above 3 Nos.

$ 1000 / accessories

15Notified 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 an emergency will be charged for airline travel & accommodation for a maximum of 3 man-days.

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