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IVDR CE Certification Cost

IVDR CE Certification Cost given below is for estimation purposes only. 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.

Team I3CGLOBAL provides strategic guidance for IVDR CE Certification. Our professionals have the expertise and know-how to navigate EU 2017/746 regulations for small, medium, and large-scale manufacturers globally by supporting all stages of technical documentation.

 

We have the necessary manpower to accommodate as many projects as possible to meet customer deadlines. Our consultants work as an extension of your regulatory team.

REQUEST IVDR QUOTE!
PRICING CALCULATOR

IVDR CE Marking Fee based on Risk Class

IVDR CLASS A STERILE

Regular

Premium

Assured

1

Regulatory Strategy, Classification and Identification of

IVDR Annexes, Standards and Guidances

X

X

X

2

Preparing and compiling IVDR Technical Documentation excluding,

Performance Evaluation and Post Market Activities

X

X

X

3

Sterilization Validation Support

–

X

X

4

Notified Body Coordination till CE granting

–

–

X

$ 4000

$8000

$13000

5

 Annual European Authorised Representative

Refer Fee >

6

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

€ 15000

⊗   A bulk discount of 50% is applicable for more than 05 IVDs, provided all technical documentation is submitted at the same time.

⊗   An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within Three months.

IVDR CLASS B

Regular

Premium

Assured

1

Regulatory Strategy, Classification and Identification of

IVDR Annexes, Standards and Guidances

X

X

X

2

Preparing and compiling IVDR Technical Documentation excluding,

Performance Evaluation and Post Market Activities

X

X

X

3

Performance Evaluation regulatory road mapping, PE Planning,

Data Synthesis and Reporting

–

X

X

4

                                    PMS Plan, PMPF Plan and PMPF Report integrated

with the outputs of RMF, PSUR, SSP and PER

 –          X        X

5

Coordinating with Third Party CRO’s and CMO’s for the

conduct of Performance Evaluation Studies

–

X

X

6

Application with multiple Notified Bodies

–

–

X

7

Notified Body Coordination till CE granting

–

–

X

$ 5000

$9000

$15000

8

 Annual European Authorised Representative

Refer Fee >

9

 Performance Evaluation Studies from External Sources

Request For Quote

10

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

€ 30000

⊗   A bulk discount of 50% is applicable for more than 10 IVDs, provided all technical documentation is submitted at the same time.

⊗   5% additional discounts for IVDD self certified devices applying with NB before May 2027

⊗   An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within Four months.

IVDR CLASS C

Regular

Premium

Assured

1

Regulatory Strategy, Classification and Identification of

IVDR Annexes, Standards and Guidances

X

X

X

2

Preparing and compiling IVDR Technical Documentation excluding,

Performance Evaluation and Post Market Activities

X

X

X

3

Performance Evaluation regulatory road mapping, PE Planning,

Data Synthesis and Reporting

–

X

X

4

                                    PMS Plan, PMPF Plan and PMPF Report integrated

with the outputs of RMF, PSUR, SSP and PER

 –          X        X

5

Coordinating with Third Party CRO’s and CMO’s for the

conduct of Performance Evaluation Studies

–

X

X

6

Application with multiple Notified Bodies

–

–

X

7

Notified Body Coordination till CE granting

–

–

X

$ 8000

$13000

$18000

8

 Annual European Authorised Representative

Refer Fee >

9

 Performance Evaluation Studies from External Sources

Request For Quote

10

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

€ 30000

⊗   A bulk discount of 20% is applicable for more than 5 IVDs, provided all technical documentation is submitted at the same time.

⊗   5% additional discounts for IVDD self certified devices applying with NB before May 2026

⊗   An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within five months.

IVDR CLASS D

Regular

Premium

Assured

1

Regulatory Strategy, Classification and Identification of

IVDR Annexes, Standards and Guidances

X

X

X

2

Preparing and compiling IVDR Technical Documentation excluding,

Performance Evaluation and Post Market Activities

X

X

X

3

Performance Evaluation regulatory road mapping, PE Planning,

Data Synthesis and Reporting

–

X

X

4

                                    PMS Plan, PMPF Plan and PMPF Report integrated

with the outputs of RMF, PSUR, SSP and PER

 –          X        X

5

Coordinating with Third Party CRO’s and CMO’s for the

conduct of Performance Evaluation Studies

–

X

X

6

Application with multiple Notified Bodies

–

–

X

7

Notified Body Coordination till CE granting

–

–

X

$ 11000

$18000

$24000

8

 Annual European Authorised Representative

Refer Fee >

9

 Performance Evaluation Studies from External Sources

Request For Quote

10

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

€ 50000

⊗   An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within Six months.

How to calculate Notified Body Fees?
#
Description of Activity
Hourly Charges in Euros
1 MDR /IVDR Technical Documentation review including Clinical Evaluation

Hours spent for documentation review, dependent on a number of factors such as device risk class, novel/state of art design, quality and completeness of the technical file during initial submission. (An average of 32 hours usually required to complete a review)

250 to 600
2 Medical Device QMS (EN ISO 13485) Onsite Audit

 

Travelling & Lodging Additional

Auditor Travelling to client location will be 125 to 175 per hour.

The client must organize the stay and local convenience.

250 to 300
3 Certification charges including printing & Dispatch.

1500
4 Unannounced Audit

(Once during the Certification tenure or any customer /Vigilance issues)

5000 to 7000
***Source of Information: Notified Body Websites

More details
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