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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 provided tentative CE Certification cost for various classes. You may need to take our final proposal after considering all variants and Intended use by filling our quote request form online. Cost of CE Marking depends on a number of technical files, Device Class, Intended use, constructional material & technology.

MDR CLASS I & IVDR CLASS A

Regular

Premium

Assured

1

Development of Technical File

X

2

Development of Declaration of Conformity (DOC)

3

Label Review

4

Biological Evaluation (Testing not Included)

X

X

5

Risk Analysis Documentation

X

X

6

Clinical Evaluation

X

X

7

PMS

X

X

$ 850

$3000

$7500

8 European Authorized Representative

$850 / Year

9 UDI Guidance

$ 600

10 EU Registration

$ 500

11 Free Sale Certificate

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MDR CLASS Is / m / r / IIa & IVDR CLASS B

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

3

Biological Evaluation

4

Risk Benefit Documentation

X

5

Clinical Evaluation Documentation

X

6

PMS + PMCF + PSUR Documentation

X

7

Application processing with Notified Bodies

X

X

8

Notified Body Coordination till CE Granting

X

X

$ 3000

$9000

$12000

9 European Authorized Representative

$ 950 / Year

10 UDI Setup &  EUDAMED Registration

$ 1000

11 Medical Device Testing

Request for Quote

12 Sterilizer Validation / Process Validation

Request for Quote

13 Clinical Evaluator (Doctor)

Request for Quote

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

15500 Euros

MDR CLASS IIb & IVDR CLASS C

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

3

Biological Evaluation

4

Risk-Benefit Documentation

X

5

Clinical Evaluation Documentation

X

6

PMS + PMCF + PSUR Documentation

X

7

Notified Body Coordination till CE granting

X

X

$ 4000

$11000

$14000

8 European Authorized Representative

$ 1100 / Year

9 UDI Setup &  EUDAMED Registration

$ 1000

10 Medical Device Testing

Request for Quote

11 Sterilizer Validation / Process Validation

Request for Quote

12 Clinical Evaluator (Doctor)

Request for Quote

13 Accessories to Active device above 3 Nos.

$ 1000 / accessories

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

18500 Euros

MDR CLASS III & IVDR CLASS D

Regular

Premium

Assured

1

Guidance on MDR requirements

2

Development of Technical File

3

Biological Evaluation

4

Risk-Benefit Documentation

X

5

Clinical Evaluation Documentation

X

6

PMS + PMCF + PSUR Documentation

X

7

Notified Body Coordination till CE granting

X

X

$ 5000

$14000

$17000

8 European Authorized Representative

$ 1300 / Year

9  UDI Setup &  EUDAMED Registration

$ 1000

10 Medical Device Testing

Request for Quote

11 Sterilizer Validation / Process Validation

Request for Quote

12 Clinical Evaluator (Doctor)

Request for Quote

13 Ancillary Medicinal Substance if…

$6000 additional

14 Accessories to Active device above 3 Nos.

$ 1000 / accessories

15 Notified 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.
How to calculate Notified Body Fees?