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Medical Device CE Marking Fees

(Technical File / Design Dossier Prepration, Consulting and Notified Body cost included)

We try to detailed below the expected cost implication that can incur during CE Certification process of your Medical Device. We hope below table will be helpfull for first timer's planning to go for CE Marking / CE Certification of Medical Device.

You can request for turnkey service quote which includes Guidance, Technical Documentation, Biocompatablity or Safety Testing, 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

Guidance on MDD Requirements  related to your Device

Free

Free

Free

100

200

Preparing Technical File / Design Dossier (Excl*)

$ 800

$ 1000

$ 1300

$ 1500

$ 1800

* Clinical Evaluation Documentation(Meddev 2.7/1 Rev.4)

$ 800

$ 1000

$ 1300

$ 1500

$ 1800

Animal Origin Devices - Technical File / Design Dossier

NA

NA

$ 1500

$ 1800

$ 1900

Radiation Emitting Devices - TCF / Design Dossier

NA

NA

$ 1600

$ 1900

$ 2100

Medical Software (SaMD) - Technical File / Design Dossier

NA

NA

$ 1400

$ 1500

$ 1600

Answering to Notified Body during Technical File review and Coordination till CE Certification

NA

$ 1200

$ 1200

$ 1400

$ 1600

Full-Fledged Risk Management File with Usablity Files

$ 500

$ 1000

$ 1000

$ 1500

$ 2000

Technical File Contents – Click Here

Responsibility Matrix – Click here

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 - 50 % advance, 30% before submission and balance after approval.
  • Drug Device combination products 40% additional fees applicable.
  • Method of communication - Telephone / Skype / G talk.
  • Language for communication – English.
  • Documentation by external Cloud server.
  • Minimum Timeline - 45-75 Days.
  • Taxes applicable as per Government rules.
  • We provided services across the Globe from Bremen Germany, Bangalore India and Chicago USA.
  • Travelling to client location will be invoiced extra.
  • 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 surprise audit and Notified body direct audits
  • Class 1 CE Compliance certification can be arranged from Certification Body

Please Fill the Request For Quote (RFQ) here:
We will send the official proposal with agreement upon receipt of filled RFQ.

Payment Methods will be send along with the proposal/agreement.

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INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp


GERMANY – Bremen
+49 2161 990 8831
Phone / Viber / WhatsApp


mail enquiry@i3cglobal.com
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