Follow Us:

I3CGlobal

Regulatory Consulting Services

Home IVDR CE Certification Cost
IVDR CE MARKING FEE

IVDR CE Certification Cost

To obtain CE marking under the IVDR, manufacturers must demonstrate compliance with the relevant requirements and undergo a conformity assessment by a notified body. The specific requirements and procedures for obtaining CE marking may vary depending on the classification of the device and the applicable conformity assessment procedure.

 

It’s important to note that the IVDR introduces several new requirements and changes to the regulatory process for IVD devices, and manufacturers should familiarize themselves with the new regulations and seek guidance from a notified body or regulatory consultant like I3CGlobal to ensure compliance.

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 & CLASS A STERILE

Regular

Premium

Assured

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

X

2

Guidance on Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

 Performance Evaluation Plan

X

X

5

PMS + PMPF + PSUR Documentation

X

X

6

Performance Evaluation Report

X

X

7

Notified Body Application and Submission

X

8

Notified Body Coordination till CE Granting

X

$ 9000

$14000

$16000

9

European Authorized Representative

950 / Year

10

UDI Setup &  EUDAMED Registration

1000

11

Performance Evaluation Studies / Testing

Request for Quote

12

Notified Body Fee per Technical Documentation File (reference purpose only)

  16000

IVDR CLASS C

Regular

Premium

Assured

1

Guidance and Technical Documentation as EU 2017/746 requirements

X

X

X

2

Guidance on Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

Performance Evaluation Plan & 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 certification granting

X

$ 10000

$16000

$18000

8

European Authorized Representative

1100 / Year

9

Performance Evaluation Studies / Testing

Request For Quote

10

Notified Body Fee per Technical Documentation File (reference purpose only).

20000

IVDR CLASS D

Regular

Premium

Assured

1

Guidance and Technical Documentation

X

X

X

2

Guidance on Analytical and Clinical Performance

X

X

X

3

Risk Management as per Annex II Section 6

X

X

X

4

                                     Performance Evaluation Plan & 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 Coordination till CE granting

X

$ 11000

$18000

$22000

8

European Authorized Representative

1300 / Year

9

Performance Evaluation Studies / Testing

Request For Quote

10

Notified Body Fee per Technical Documentation File (reference purpose only).

40000

How to calculate Notified Body Fees?