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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.

MDR CLASS I & IVDR CLASS A

Regular

Premium

Assured

1

Development of Technical File

X

X

2

Development of Declaration of Conformity (DOC)

3

Label Review

X

4

Biological Evaluation (Testing not Included)

X

X

5

Risk Analysis Documentation

X

X

6

Clinical Evaluation

X

X

7

PMS

X

X

$ 850

$1550

$7500

8 European Authorized Representative

$ 700 / Year

9 Third-Party Compliance Certificate

$ 600 / Year

10 EU Registration

$ 200

11 EU Registration Certificate (Issued by EAR)

$ 300

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

8

Notified Body Coordination till CE Granting

X

X

$ 3000

$9000

$12000

9 European Authorized Representative

$ 950 / Year

10 EU Registration

$ 500

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 EU Registration

$ 500

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 EU Registration

$ 500

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 Notified Body Fees Calculated?

#
Description of Activity
Hourly Charges in Euros
1 MDR /IVDR Technical Documentation review including Clinical Evaluation

 

Hours spent for documentation reviews is dependent on a number of  critical factors such as device risk 

class, Novel / state of art design, quality and completeness of the technical file during initial submission.

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

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 published websites