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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
  • 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)*

ActivityClass of Medical Device
IIs / Im / IrIIaIIbIII
Technical File3500600090001200016000
Support in Notified Body Coordination till Technical File ApprovalNA1000120018003000
total35007000102001380019000

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

(f) Animal Origin Or Radiation Emitting100015002000
(g) Ancillary Medicinal Substances3000
(h) Software driven / Standalone Devices10002000200020002000
Tentative NB Certification Fees (Euro)NA9000120001800025000
    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)*

ActivityClass of Medical Device
ABCD
Technical File35007000950016000
Support in Notified Body Coordination till Technical File ApprovalNA120018003000
total350082001130019000

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

(h) Software driven / Standalone Devices1000200020002000
Tentative NB Certification FeesNA90001500022000
    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)

ActivityClass of Medical Device
IIs / Im / IrIIaIIbIII
Literature Search Protocol & Literature Search Report only15003000350050007500
Complete Clinical Evaluation Plan & Report20004500600080009000
    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)

ActivityClass of Medical Device
Complete Risk Management Plan and ReportClass I & Class AClass Is / Im / Ir & Class BClass IIa & Class CClass IIb & Class CClass III & Class D
8501500200025003000
    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
(2021 Financial year)
Non Implantable Devices
(All prices are in USD)
USFDA 510k Review Fees : $12432 ( Standard)
FDA Establishment Registration Fees : $5546 ( To be paid after 510k clearance only)

ActivityRoute of Application
Abbreviated
510K
Traditional
510k
Special
510k
Guidance (Offsite)600070008000
510k Preparation & Review8000900010000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier100010001000
total150001700019000
    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
(2021 Financial year)
Implantable Devices
(All prices are in USD)
USFDA 510k Review Fees : $12432 ( Standard)
FDA Establishment Registration Fees : $5546 ( To be paid after 510k clearance only)

ActivityRoute of Application
Abbreviated
510K
Traditional
510k
Special
510k
Guidance (Offsite)8000900010000
510k Preparation & Review800090009000
Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier100010001000
total170001900020000
    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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