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Affordable CE Certification Cost

CE certification cost determined by multiple factors, such as technical data, device class, intended use, construction material, number of models and variants, and finally, the technology used. 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. Check out our affordable CE Certification Cost  below.

 

The increased requirements and changes introduced by the MDR have led to an increase in the cost of CE certification. Manufacturers are now required to provide more comprehensive technical documentation and undergo a more rigorous conformity assessment process, which can result in higher costs for certification.

 

The CE certification cost increased significantly after the introduction of Regulation (EU) 2017/745, commonly referred to as the Medical Devices Regulation (MDR). This regulation, which came into effect on May 26, 2022, replaced the previous Medical Devices Directive (MDD) and introduced several new requirements and changes to the regulatory process for medical devices.

 

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

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

Note:

  • CE Certification cost quoted per Intended use / technical File/construction/design.
  • Additional technical files are 25% discounted.
  • Travel & accommodation extra for a maximum of 3 man-days.

How to calculate Notified Body Fees?