CE Marking Fees


Medical Device CE Marking Fees

(Consulting, Technical File Prepration, Notified Body costing included)

In this page we detailed the pricing for each major activity involved in medical device CE Certification. We are sure, below information will be very helpful for those planning for MDR CE Marking for the first time. Price variation from the below table happens in case of multiple models and variants.

You can request for turnkey service quote which includes Guidance, Technical Documentation, Biocompatablity or Electrical Safety, European Authorized Representative and Notified Body Fees.

A. Guidance and Documentation Fees ( MDD/AIMD)  



Activity

Class of  Medical Device

1

1s/m

11a

11b

111

(a) MDR Technical File & Guidance

$ 1500

$ 1500

$ 2000

$ 2000

$ 3000

(b) Animal Orgin Or Radiation Emitting

(Additional Fees to "a")

-

-

-

$ 1500

$ 2000

(c) Ancillary Medicinal Substances

(Additional Fees to "a")

-

-

-

-

$ 2000

(d) Software driven / Standalone Devices

(Additional Fees to "a")

$ 1000

$ 1500

$ 1500

$ 1500

$ 1500

(e) Risk Analysis Support with Usablity Files

(Additional Fees to "a")

-

$ 500

$ 500

$ 750

$ 1000

(f) CER Report with PMS and PMC

(Additional Fees to "a & e")

$ 1000

$ 1000

$ 1500

$ 1500

$ 2000

(g) Complete Notified Body Coordination till Technical File Approval

(Additional Fees to "a, e & f")

NA

$ 1500

$ 1500

$ 1500

$ 2000

CALCULATE ESTIMATE

B. Guidance and Documentation Fees ( IVD )  


Activity

  IVD Type / List

Self

B (LR)

B (HR)

A

Guidance on IVD Requirements  related to Device for CE Marking

$ 300

$ 400

$ 500

$ 600

Preparing Technical File

$ 1800

$ 2300

$ 2500

$ 3000

Support in closing NB review comments

NA

$ 11000

$ 1200

$ 1400

Label Review

$ 500

$ 600

$ 700

$ 800

Important:

  • OBL / PLM will be charged 30 % less
  • Payment Terms: Initial Advance 40%, before TF submission 20%, answering to initial NB comments 20% and balance after approval.
  • Method of communication: Telephone / Skype / Email.
  • Language for communication – English.
  • Complete Documentation in external Cloud (Dropbox).
  • Minimum Timeline: 45-75 Days.
  • Taxes applicable as per Government rules.
  • Consultant Onsite visit arranged from Bremen Germany, Bangalore India and Chicago USA.
  • Consultant Onsite visit will be invoiced on actuals.
  • Don’t forget to get NB quote from us for price comparison!!!


C. Notified Body CE Certification Fees ( For Reference purpose ONLY)

Class of Device

First Year Fee

EURO

INR

Class 1 CE Certification

Self

Self

Class 1s & Class Im CE Certification

10000

800000

Class 11a CE Certification

12000

1000000

Class 11b CE Certification

14000

1200000

IVD ( List B / A) & MDD Class 111 CE Certification

18000

1500000

Important:

  • CE Certificate validity is five years
  • Auditor travelling and Lodging additional
  • Annual Surveillance Fee will be 35% of the initial year fee
  • Client should be invoiced separately for unannounced audits by Notified Body.
  • Class 1 CE Compliance Certificate can be arranged from Germany Office

Looking for a detailed estimate? Please fill up the Request for Quote and submit online. Our Experts will study the information submitted and will revert back to you soon.


Request For Quote – Click Here

Technical File Contents – Click Here

Responsibility Matrix – Click here

CER Pricing – Click here

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INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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