ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

CE MARKING FEES (Medical Devices)

Service provided across the Globe from Bangalore, India and Chicago, USA.
You can request for turnkey service quote which includes guidance, documentation, testing and Notified Body audit.

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

Identification of Class and Harmonized Standards

Free

Free

Free

Free

Free

Preparing Technical File / Design Dossier

$ 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 - Technical file / Design Dossier

NA

NA

$ 1400

$ 1500

$ 1600

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

$ 500

$ 1200

$ 1200

$ 1400

$ 1600

Label Review

$ 100

$ 200

$ 200

$ 300

$ 300

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 / Design Dossier

$ 1800

$ 2300

$ 2500

$ 3000

Support in closing NB reviewer 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.
  • 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

Self

Self

Class 1s/m

7500

540000

Class 11a

9500

684000

Class 11b

11500

828000

IVD ( List B / A) MDD and Class 111

14500

1044000

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


mail enquiry@i3cglobal.com
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