How much does CE Certification Cost?

Are you unsure how much a CE Certification Cost for medical device as per MDR and IVDR?

CE certification cost are determined by multiple factors such as technical data, device Class, intended use, construction material, number of models and variants and finally, the technology used. Check out our affordable CE certification cost of medical device price below. Our estimates are nearly always accurate, and we don’t charge you more for any extra work—our guarantee. We will not abandon you in the middle of your journey.

MDR CE Certification Cost (Fee)

MDR CLASS I

		Regular	Premium
1	Prepare Technical Documentation ensuring EU 2017/745 Compliance	X	X
2	Identification of Common and product-specific Standards	X	X
3	Guidance and review of Device Label and IFU /UM	X	X
4	Biological Evaluation (Testing not Included)	X	X
5	Risk Analysis Documentation	X	X
6	Clinical Evaluation Report Documentation	–	X
7	Post Market Surveillance and PSUR	–	X
		$ 5000	$8000
8	European Authorized Representative	€ 850 / Year
9	UDI Guidance & EUDAMED setup	€ 1000
10	EU Registration	€ 500
11	Free Sale Certificate	Contact Us

MDR CLASS Is/Im/Ir

		Regular	Premium	Assured
1	Guidance on EU 2017/745 compliance requirements	X	X	X
2	Prepare Technical Documentation ensuring EU 2017/745 Compliance	X	X	X
3	Biological Evaluation (Testing not covered)	X	X	X
4	Risk-Benefit Documentation	X	X	X
5	Clinical Evaluation Report Documentation	–	X	X
6	PMS + PMCF + PSUR Documentation	–	X	X
7	Identify and Apply with Notified Body	–	–	X
8	Notified Body Coordination till CE granting	–	–	X
		$ 6000	$ 10000	$ 12000
9	European Authorized Representative	€ 1050 / Year
10	UDI Setup & EUDAMED Registration	€ 1000
11	Medical Device Testing	Request for Quote
12	Sterilizer Validation / Process Validation	Request for Quote
13	Clinical Evaluator (Doctor)	Request for Quote
14	Notified Body Fees / Technical File (reference purpose only)	€ 20000

MDR CLASS IIa

		Regular	Premium	Assured
1	Guidance on EU 2017/745 compliance requirements	X	X	X
2	Prepare Technical Documentation ensuring EU 2017/745 Compliance	X	X	X
3	Biological Evaluation (Testing not covered)	X	X	X
4	Risk-Benefit Documentation	X	X	X
5	Clinical Evaluation Report Documentation	–	X	X
6	PMS + PMCF + PSUR Documentation	–	X	X
7	Identify and Apply with Notified Body	–	–	X
8	Notified Body Coordination till CE granting	–	–	X
		$ 6000	$10000	$14000
9	European Authorized Representative	€ 1050 / Year
10	UDI Setup & EUDAMED Registration	€ 1000
11	Medical Device Testing	Request for Quote
12	Sterilizer Validation / Process Validation	Request for Quote
13	Clinical Evaluator (Doctor)	Request for Quote
14	Notified Body Fees / Technical File (reference purpose only)	€ 20000

MDR CLASS IIb

		Regular	Premium	Assured
1	Guidance on EU 2017/745 compliance requirements	X	X	X
2	Prepare Technical Documentation ensuring EU 2017/745 Compliance	X	X	X
3	Biological Evaluation (Testing not covered)	X	X	X
4	Risk-Benefit Documentation	X	X	X
5	Clinical Evaluation Report Documentation	–	X	X
6	PMS + PMCF + PSUR Documentation	–	X	X
7	Notified Body Coordination till CE granting	–	–	X
		$ 8000	$12000	$16000
8	European Authorized Representative	€ 1150 / Year
9	UDI Setup & EUDAMED Registration	€ 1000
10	Medical Device Testing	Request for Quote
11	Sterilizer Validation / Process Validation	Request for Quote
12	Clinical Evaluator (Doctor)	Request for Quote
13	Accessories to Active device above 3 Nos.	€ 1000 / accessories
14	Notified Body Fees / Technical File (reference purpose only).	€ 25000

MDR CLASS III

		Regular	Premium	Assured
1	Guidance on EU 2017/745 compliance requirements	X	X	X
2	Prepare Technical Documentation ensuring EU 2017/745 Compliance	X	X	X
3	Biological Evaluation (Testing not covered)	–	X	X
4	Risk-Benefit Documentation	–	X	X
5	Clinical Evaluation Report Documentation	–	X	X
6	PMS + PMCF + PSUR Documentation	–	X	X
7	Notified Body Coordination till CE granting	–	–	X
		$ 13000	$17000	$22000
8	European Authorized Representative	€ 1350 / Year
9	UDI Setup & EUDAMED Registration	€ 1000
10	Medical Device Testing	Request for Quote
11	Sterilizer Validation / Process Validation	Request for Quote
12	Clinical Evaluator (Doctor)	Request for Quote
13	Ancillary Medicinal Substance if…	$6000 additional
14	Accessories to Active device.	€ 1000 / accessories
15	Notified Body Fees / Technical File (reference purpose only).	€ 30000

The CE Certification cost for various classes is estimated below. You will get an official proposal after submitting an online quote request form. CE Marking costs are determined by multiple factors such as technical data, device Class, intended use, construction material, number of models and variants and finally, the technology used.

Note:

CE Certification cost / price quoted per Intended use / technical File / construction /design.
Additional technical File 25% discounted
Consultant travel to client location for an emergency will be charged for airline travel & accommodation for a maximum of 3 man-days.

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IVDR CE Certification Cost (Fee)

IVDR CLASS A

		Regular	Premium
1	Guidance and Technical Documentation as EU 2017/746 requirements	X	X
2	Analytical and Clinical Performance	X	X
3	Risk Management as per Annex II Section 6	X	X
4	Performance Evaluation Report	–	X
5	PMS + PMPF Documentation	–	X
6	Label Review and Guidance	X	X
7	Support with Declaration of Conformity	X	X
		$ 5000	$8000
8	European Authorized Representative	€ 850 / Year
9	UDI Guidance	€ 600
10	EU Registration	€ 500
11	Free Sale Certificate	Contact Us

IVDR CLASS B & CLASS A STERILE

		Regular	Premium	Assured
1	Guidance and Technical Documentation as EU 2017/746 requirements	X	X	X
2	Guidance on Analytical and Clinical Performance	X	X	X
3	Risk Management as per Annex II Section 6	X	X	X
4	Performance Evaluation Plan	–	X	X
5	PMS + PMPF + PSUR Documentation	–	X	X
6	Performance Evaluation Report	–	X	X
7	Notified Body Application and Submission	–	–	X
8	Notified Body Coordination till CE Granting	–	–	X
		$ 9000	$14000	$16000
9	European Authorized Representative	€ 950 / Year
10	UDI Setup & EUDAMED Registration	€ 1000
11	Performance Evaluation Studies / Testing	Request for Quote
12	Notified Body Fee per Technical Documentation File (reference purpose only)	€ 16000

IVDR CLASS C

		Regular	Premium	Assured
1	Guidance and Technical Documentation as EU 2017/746 requirements	X	X	X
2	Guidance on Analytical and Clinical Performance	X	X	X
3	Risk Management as per Annex II Section 6	X	X	X
4	Performance Evaluation Plan & Report	–	X	X
5	Summary of Safety and Performance as per Article 29	–	X	X
6	PMS + PMPF + PSUR Documentation	–	X	X
7	Notified Body Application, Submission & Coordination till CE certification granting	–	–	X
		$ 10000	$16000	$18000
8	European Authorized Representative	€ 1100 / Year
9	Performance Evaluation Studies / Testing	Request For Quote
10	Notified Body Fee per Technical Documentation File (reference purpose only).	€ 20000

IVDR CLASS D

		Regular	Premium	Assured
1	Guidance and Technical Documentation	X	X	X
2	Guidance on Analytical and Clinical Performance	X	X	X
3	Risk Management as per Annex II Section 6	X	X	X
4	Performance Evaluation Plan & Report	–	X	X
5	Summary of Safety and Performance as per Article 29	–	X	X
6	PMS + PMPF + PSUR Documentation	–	X	X
7	Notified Body Coordination till CE granting	–	–	X
		$ 11000	$18000	$22000
8	European Authorized Representative	€ 1300 / Year
9	Performance Evaluation Studies / Testing	Request For Quote
10	Notified Body Fee per Technical Documentation File (reference purpose only).	€ 40000

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How to calculate Notified Body Fees?

#	Description of Activity	Hourly Charges in Euros
1	MDR /IVDR Technical Documentation review including Clinical Evaluation Hours spent for documentation review, dependent on a number of factors such as device risk class, novel/state of art design, quality and completeness of the technical file during initial submission. (An average of 32 hours usually required to complete a review)	250 to 600
2	Medical Device QMS (EN ISO 13485) Onsite Audit Travelling & Lodging Additional Auditor Travelling to client location will be 125 to 175 per hour. The client must organize the stay and local convenience.	250 to 300
3	Certification charges including printing & Dispatch.	1500
4	Unannounced Audit (Once during the Certification tenure or any customer /Vigilance issues)	5000 to 7000
	***Source of Information: Notified Body Websites

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