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CE Certification Cost
Priced for value, defined by quality and excellence — not just numbers.

Pricing

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  2. Pricing

MDR & IVDR TENTATIVE CE CERTIFICATION COST (FEES)

Below provided tentative CE Certification cost for various classes. You may need to take our final proposal after considering all variants and Intended use by filling our quote request form online.

Cost of CE Marking depends on a number of technical files, Device Class, Intended use, constructional material & technology.

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REGULATORY PRICING

  • CE-Medical
  • CE-IVD
  • UKCA
  • US FDA 510 (K)

Pricing of Medical Device CE Marking as per EU MDR (All prices are in EURO)*

Activity Class of Medical Device
I Is / Im / Ir IIa / IIa (Active) IIb / IIb (Active) III
Technical documentation preparation and coordination with Notified body till certification 4000 5250 7000 / 8200 9500 / 12500 14000
Tentative NB Certification Fees NA 12000-15000 15000-20000 20000-25000 25000-30000
EAR Fee 1200 1200-1400 1400-1800 1800-2000 2000-2500
    Note:

  • Prices quoted above are considering one product and it may vary depending upon exact Intended use or GMDN codes / Nando codes.
  • It may vary and depend on exact product specification, models and other requirements.

Pricing of In vitro Diagnostics Medical Device CE Marking as per EU MDR (All prices are in EURO)*

Activity Class of Medical Device
A (Non-Sterile) A (Sterile) B C D
Technical documentation preparation and coordination with Notified body till certification 4000 5000 8200 9500 14000
Tentative NB Certification Fees NA 12000-15000 15000-20000 20000-25000 25000-35000
EAR Fee 1000 1200-1400 1400-1600 1600-1800 1800-2000
    Note:

  • *Prices quoted above are considering one product and it may vary depending upon exact Intended use or GMDN codes / Nando codes.
  • It may vary and depend on exact product specification, models and other requirements.

Pricing of UKCA (All prices are in EURO)*

Activity Class of Medical Device
I Is / Im / Ir IIa / IIa (Active) IIb / IIb (Active) III
Technical documentation preparation and coordination with Notified body till certification 4000 5250 7000 / 8200 9500 / 12500 14000
Tentative NB Certification Fees NA 12000-15000 15000-20000 20000-25000 25000-30000
    Note:

  • Prices quoted above are considering one product and it may vary depending upon exact Intended use or GMDN codes / Nando codes.
  • It may vary and depend on exact product specification, models and other requirements.

FDA 510k Budgetary Costing
Fiscal Year 2025 (October 1, 2024, through September 30, 2025)
(All prices are in USD)
USFDA 510k Review Fees : $24,335 ( Standard) & $6,084 (Small Business Fee)
FDA Establishment Registration Fees : $9,280 ( To be paid after 510k clearance only)

US FDA510 (k) Fees ($)
Consultation Fee (Non-Implantable Devices) 18000
Consultation Fee (Implantable Devices) 20000
    Note:

  • Price quoted per Intended use.
  • It may vary and depend on exact product specification, models and other requirements.
  • Testing Cost is not included in above fees

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Technical File

The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to NB or CA for review & approval for CE certification.

Clinical Evaluation

Clinical evaluation enables manufacturers to provide sufficient clinical evidence for demonstration of conformity of the device with the general safety and performance requirements.

Indian Medical Device Rules

In India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017

510k Approval

For legal commercialization of your product, 510k approval process need to be carried out by choosing the type of 510k and complying to the requirements established by the USFDA

NIOSH Certification

NIOSH must certify any respirator or respiratory protective product before it can be used in any workplace: medical, industrial, educational, etc. The regulation that empowers NIOSH to regulate and certify respiratory protective products is 42 CFR Part 84.