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1. MDR Fees (Technical Documentation and Notified Body)
2. MDR Guidance and Documentation Fees
3. IVDR Guidance and Documentation Fees
4. Notified Body Fees (Reference purpose Only)

MDR Fees (Technical Documentation and Notified Body)  

MDR Fees on this page, we detailed the pricing for each major activity involved in medical device CE Certification. We are sure, the 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 the case of multiple models and variants.

You can request a turnkey service quote, including Guidance, Technical Documentation, Biocompatibility or Electrical Safety, European Authorized Representative, and Notified Body Fees.

MDR Guidance and Documentation Fees

Activity

Class of Medical Device
1 Is/Im/Ir 11a 11b 111
(a) MDR Technical File & Guidance $ 3500 $ 5000 $ 6000 $ 8000 $ 9000
(b) Animal Origin 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”)

 $ 2000 $ 3000 $ 4000 $ 5000 $ 6000
(e) Risk Analysis Support with Usability Files

(Additional Fees to “a”)

 – $ 1500 $ 1600 $ 1850 $ 2000
(f) Clinical Evaluation

(Additional Fees to “a & e”)

 $ 2999 $ 3999 $4999 $ 6999 $ 7999
(g) PMS + PMCF + PSUR

(Additional Fees to “a, e & f”)

 $ 1500 $ 1500 $ 1500 $ 2000 $ 3000
(h) Complete Notified Body Coordination till Technical File Approval

(Additional Fees to “a, e, f & g”)

 NA $ 2500 $ 2500 $ 3000 $ 5000

IVDR Guidance and Documentation Fees

Activity

  IVD Type / List

Self

B (LR)

B (HR)

A

Guidance on IVD Requirements related to Device for CE Marking

$ 1300

$ 1400

$ 1500

$ 1600

Preparing Technical File

$ 3800

$ 4300

$ 6500

$ 7000

Support in closing NB review comments

NA

$ 3000

$ 4200

$ 5400

Label Review

$ 500

$ 600

$ 700

$ 800

Important

  • OBL / PLM will be charged 30 % less
  • Payment Terms: Initial Advance 40%, before TF submission 20%, answering initial NB comments 20%, and balance after approval.
  • Method of communication: Telephone / Skype / Email.
  • Language for communication – English.
  • Complete Documentation in the external Cloud (Dropbox).
  • Minimum Timeline: 45-75 Days.
  • Taxes are 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 an NB quote from us for price comparison!!!

Notified Body Fees (Reference purpose Only)

Class of Device First Year Fees
EURO USD
Class 1 CE Certification Self Self
Class 1s / 1r /1m CE Certification 12000 12500
Class 11a CE Certification 13000 13500
Class 11b CE Certification 16000 17000
IVD (List B / A) & MDD Class 111 CE Certification 24000 26000

Important

  • CE Certificate validity is five years
  • Auditor traveling and lodging additional
  • The annual Surveillance Fees will be 35% of the initial year fees
  • The client should be invoiced separately for unannounced audits by Notified Bodies.
  • Class 1 CE Compliance Certificate can be arranged from Germany Office

Request for Proposal form can be filled and submitted online for a quick reply from our expert.