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How much does CE Certification Cost?

Are you unsure how much a ce marking process for medical device will cost as per MDR and IVDR?

Check out our anticipated CE Certification Cost of Medical Devices price below. Our estimates are nearly always accurate, and we don’t charge you more for any extra work—our guarantee. We will not abandon you in the middle of your journey.

ce certification cost

MDR Tentative CE Certification Cost (Fees)

MDR CLASS I

Regular

Premium

1

 Prepare Technical Documentation ensuring EU 2017/745 Compliance

X

X

2

Identification of Common and product-specific Standards

X

X

3

Guidance and review of Device Label and IFU /UM

X

          X

4

Biological Evaluation (Testing not Included)

X

X

5

Risk Analysis Documentation

X

X

6

Clinical Evaluation Report Documentation

X

7

Post Market Surveillance and PSUR

X

$ 5000

$8000

8 European Authorized Representative

850 / Year

9 UDI Guidance & EUDAMED setup

1000

10 EU Registration

500

11 Free Sale Certificate

Contact Us

MDR CLASS Is/Im/Ir

Regular

Premium

Assured

1

Guidance on EU 2017/745 compliance requirements

X

X

X

2

Prepare Technical Documentation ensuring EU 2017/745 Compliance

X

X

X

3

Biological Evaluation (Testing not covered)

X

X

X

4

Risk-Benefit Documentation

X

X

X

5

Clinical Evaluation Report Documentation

X

X

6

PMS + PMCF + PSUR Documentation

X

X

7

Identify and Apply with Notified Body

X

8

Notified Body Coordination till CE granting

X

$ 6000

$ 10000

$ 12000

9 European Authorized Representative

1050 / 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)

20000

MDR CLASS IIa

Regular

Premium

Assured

1

Guidance on EU 2017/745 compliance requirements

X

X

X

2

Prepare Technical Documentation ensuring EU 2017/745 Compliance

X

X

X

3

Biological Evaluation (Testing not covered)

X

X

X

4

Risk-Benefit Documentation

X

X

X

5

Clinical Evaluation Report Documentation

X

X

6

PMS + PMCF + PSUR Documentation

X

X

7

Identify and Apply with Notified Body

X

8

Notified Body Coordination till CE granting

X

$ 6000

$10000

$14000

9 European Authorized Representative

1050 / 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)

20000

MDR CLASS IIb

Regular

Premium

Assured

1

Guidance on EU 2017/745 compliance requirements

X

X

X

2

Prepare Technical Documentation ensuring EU 2017/745 Compliance

X

X

X

3

Biological Evaluation (Testing not covered)

X

X

X

4

Risk-Benefit Documentation

X

X

X

5

Clinical Evaluation Report Documentation

X

X

6

PMS + PMCF + PSUR Documentation

X

X

7

Notified Body Coordination till CE granting

X

$ 8000

$12000

$16000

8 European Authorized Representative

1150 / 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).

25000

MDR CLASS III

Regular

Premium

Assured

1

Guidance on EU 2017/745 compliance requirements

X

X

X

2

Prepare Technical Documentation ensuring EU 2017/745 Compliance

X

X

X

3

Biological Evaluation (Testing not covered)

X

X

4

Risk-Benefit Documentation

X

X

5

Clinical Evaluation Report Documentation

X

X

6

PMS + PMCF + PSUR Documentation

X

X

7

Notified Body Coordination till CE granting

X

$ 13000

$17000

$22000

8 European Authorized Representative

1350 / 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.

1000 / accessories

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

30000

The CE Certification cost for various classes is estimated below. You will get an official proposal after submitting an online quote request form. CE Marking costs are determined by multiple factors such as technical data, device Class, intended use, construction material, number of models and variants and finally, the technology used.

Note:

  • CE Certification cost / 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.

IVDR Tentative CE Certification Cost (Fees)

IVDR CLASS A

Regular

Premium

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

2

Analytical and Clinical Performance

X

X

3

Risk Management as per Annex II Section 6

X

X

4

Performance Evaluation Report

 X

5

PMS + PMPF Documentation

X

6

Label Review and Guidance

X

X

7

Support with Declaration of Conformity

X

X

$ 5000

$8000

8 European Authorized Representative

  850 / Year

9 UDI Guidance

600

10 EU Registration

500

11 Free Sale Certificate

Contact Us

IVDR CLASS B

Regular

Premium

Assured

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

X

2

Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

 Performance Evaluation Report

X

X

5

PMS + PMPF + PSUR Documentation

X

X

6

PMS + PMCF + PSUR Documentation

X

X

7

Notified Body Application and Submission

X

8

Notified Body Coordination till CE Granting

X

$ 6000

$10000

$14000

9

European Authorized Representative

950 / Year

10

UDI Setup &  EUDAMED Registration

1000

11

External Performance evaluation

Request for Quote

12

Notified Body Fees / Technical File (reference purpose only)

  15500

IVDR CLASS C

Regular

Premium

Assured

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

X

2

Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

Performance Evaluation Report

X

X

5

 Summary of Safety and Performance as per Article 29

X

X

6

PMS + PMPF + PSUR Documentation

X

X

7

Notified Body Application, Submission & Coordination till CE granting

X

$ 8000

$11000

$15000

8

European Authorized Representative

1100 / Year

9

UDI Setup &  EUDAMED Registration

1000

10

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

25000

IVDR CLASS D

Regular

Premium

Assured

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

X

2

Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

                                     Performance Evaluation Report

         X        X

5

 Summary of Safety and Performance as per Article 29

X

X

6

PMS + PMPF + PSUR Documentation

X

X

7

Notified Body Application, Submission & Coordination till CE granting

X

$ 10000

$15000

$20000

8

European Authorized Representative

1300 / Year

9

 UDI Setup &  EUDAMED Registration

1000

10

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

40000

How to calculate Notified Body Fees?