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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.

REGULATORY PRICING

  • CE-Medical
  • CE-IVD
  • Clinical
  • UKCA
  • Risk Management
  • US FDA Non-Implantable Devices
  • US FDA Implantable Devices

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

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 3750 5250 6250 / 7000 8250 / 9000 12000

Additional Cases where further documentation shall be required depending upon product description

(f) Animal Origin Or Radiation Emitting 1000 1500 2000
(g) Ancillary Medicinal Substances 3000
(h) Software driven / Standalone Devices 1000 2000 2000 2000 2000
Tentative NB Certification Fees (Euro) NA 9000 12000 18000 25000
    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 USD)*

Activity Class of Medical Device
A B C D
Technical documentation preparation and coordination with Notified body till certification 3750 5250 7000 9000

Additional Cases where further documentation shall be required depending upon product description

(h) Software driven / Standalone Devices 1000 2000 2000 2000
Tentative NB Certification Fees NA 9000 15000 22000
    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 Medical Device Clinical Evaluation as per EU MDR (All prices are in USD)

Activity Class of Medical Device
I Is / Im / Ir IIa IIb III
Literature Search Protocol & Literature Search Report only 1500 3000 3500 5000 7500
Complete Clinical Evaluation Plan & Report 2000 4500 6000 8000 9000
    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 USD)*

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 3750 5250 6250 / 7000 8250 / 9000 12000

Additional Cases where further documentation shall be required depending upon product description

(f) Animal Origin Or Radiation Emitting 1000 1500 2000
(g) Ancillary Medicinal Substances 3000
(h) Software driven / Standalone Devices 1000 2000 2000 2000 2000
Tentative NB Certification Fees (Euro) NA 9000 12000 18000 25000
    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 Medical Device Risk Management as per EU MDR (All prices are in USD)

Activity Class of Medical Device
Complete Risk Management Plan and Report Class I & Class A Class Is / Im / Ir & Class B Class IIa & Class C Class IIb & Class C Class III & Class D
850 1500 2000 2500 3000
    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
2023 Financial Year (October 1, 2022, through September 30, 2023)
Non Implantable Devices
(All prices are in USD)
USFDA 510k Review Fees : $19870 ( Standard)
FDA Establishment Registration Fees : $6493 ( To be paid after 510k clearance only)

Activity Route of Application
Abbreviated
510K
Traditional
510k
Special
510k
Guidance (Offsite) 6000 7000 8000
510k Preparation & Review 8000 9000 10000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier 1000 1000 1000
total 15000 17000 19000
    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

FDA 510k Budgetary Costing
2023 Financial Year (October 1, 2022, through September 30, 2023)
Implantable Devices
(All prices are in USD)
USFDA 510k Review Fees : $19870 ( Standard)
FDA Establishment Registration Fees : $6493 ( To be paid after 510k clearance only)

Activity Route of Application
Abbreviated
510K
Traditional
510k
Special
510k
Guidance (Offsite) 8000 9000 10000
510k Preparation & Review 8000 9000 9000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier 1000 1000 1000
total 17000 19000 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

Error free submission. Expert advice. Cost-Effective rates

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Our Services

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.

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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.

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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

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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

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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.

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