Pricing for CE Mark, CE IVD, and USFDA Certifications

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
Consultation and Technical Document Preparation	5000	6250	8000 / 9250	11000 / 13500	16500
Tentative NB Certification Fees	NA	12000-15000	15000-20000	20000-25000	25000-30000
EAR Fee	1200	1200-1400	1400-1800	1800-2000	2000-2500

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
Consultation and Technical Document Preparation	5000	6250	9250	11000	16500
Tentative NB Certification Fees	NA	12000-15000	15000-20000	20000-25000	25000-35000
EAR Fee	1000	1200-1400	1400-1600	1600-1800	1800-2000

*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
Consultation and Technical Document Preparation	5000	6250	8000 / 9250	11000 / 13500	16500
Tentative NB Certification Fees	NA	12000-15000	15000-20000	20000-25000	25000-30000

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 2026 (October 1, 2025, through September 30, 2026)
(All prices are in USD)
USFDA 510k Review Fees : $26,067 ( Standard) & $6,517 (Small Business Fee)
FDA Establishment Registration Fees : $11,423 ( To be paid after 510k clearance only)

US FDA510 (k)	Fees ($)
Consultation Fee (Non-Implantable Devices)	20000
Consultation Fee (Implantable Devices)	22000

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

Our Services

CE Marking

CE Marking Support for Medical Devices and IVDs

Navigating CE marking requirements can be challenging, especially under the EU MDR and IVDR. At Maven, we help medical device and IVD manufacturers achieve CE certification through practical regulatory support, including technical documentation preparation, clinical evaluation, risk management, GSPR compliance, post-market activities, and audit readiness. Our consultants work closely with manufacturers to simplify the conformity assessment process and support successful access to the European market.

US FDA

US FDA 510(k) Consulting Services

Bringing a medical device to the U.S. market requires more than just submitting documents. It demands a clear regulatory strategy, the right predicate selection, and a thorough understanding of FDA expectations. At Maven, we support medical device and IVD manufacturers throughout the FDA 510(k) process, from product classification and performance requirements to eSTAR preparation and submission, helping streamline the path toward successful FDA clearance.

UKCA

UKCA Certification for Medical Devices & IVDs

Expanding into the UK market requires more than just regulatory documentation. Maven helps medical device and IVD manufacturers navigate UKCA certification requirements with confidence, from MHRA registration and technical documentation review to UK Responsible Person support and regulatory compliance. Our practical, hands-on approach helps streamline the certification process, reduce delays, and support successful market access in Great Britain.

ISO 13485

ISO 13485 Quality Management System

ISO 13485 is more than a certification requirement. It provides a structured framework for medical device manufacturers to consistently meet regulatory requirements, manage risks, maintain product quality, and improve operational efficiency. A well implemented Quality Management System (QMS) helps organizations streamline processes, strengthen compliance, and build confidence among regulators, customers, and business partners. With the right regulatory strategy and implementation approach, ISO 13485 can become a foundation for successful market access and long term business growth.

CDSCO India

CDSCO Regulatory Support for Medical Devices & IVDs

Navigating CDSCO requirements can be challenging without the right regulatory expertise. Maven helps medical device and IVD manufacturers secure CDSCO approvals, including Import Licenses, Manufacturing Licenses, Test Licenses, and Loan Licenses. Our team provides practical regulatory guidance, documentation support, and end to end assistance to help businesses achieve compliance, reduce approval delays, and bring products to the Indian market with confidence.