CE Certification Cost

CE certification cost for medical device determined by multiple factors, such as technical data, device class, intended use, construction material, number of models and variants, and finally, the technology used. 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. Check out our affordable CE Certification cost below.

The increased requirements and changes introduced by the MDR have led to an increase in the medical device CE certification cost. Manufacturers are now required to provide more comprehensive technical documentation and undergo a more rigorous conformity assessment process, which can result in higher costs for certification.

The CE certification cost increased significantly after the introduction of Regulation (EU) 2017/745, commonly referred to as the Medical Devices Regulation (MDR). This regulation, which came into effect on May 26, 2022, replaced the previous Medical Devices Directive (MDD) and introduced several new requirements and changes to the regulatory process for medical devices.

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

CE Certification Cost Based on Risk Class

MDR CLASS I

		Regular	Premium
1	Prepare Technical Documentation File 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	EUDAMED (Actor +SRN)	€ 600
10	EU Registration (Optional)	€ 500
11	Free Sale Certificate (Optional)	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	EUDAMED (Actor + SRN)	€ 600
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	EUDAMED (Actor + SRN)	€ 600
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	EUDAMED (Actor +SRN) activation	€ 650
10	Biocompatibility Testing	Request for Quote
11	Electrical Safety Testing	Request for Quote
12	Drug Master File (DDC / DID)	9000 USD (partial) 16000 USD (Full)
13	Accessories to Active device above 2 Nos.	€ 2000 / 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	EUDAMED (Actor + SRN)	€ 600
10	Biocompatibility Testing	Request for Quote
11	Electrical Safety Testing	Request for Quote
12	Drug Master File	$9000 (Partial) $16000 (Full)
13	Ancillary Medicinal Substance if…	$6000 additional
14	Accessories to Active device.	€ 1000 / accessories
15	Notified Body Fees / Technical File (reference purpose only).	€ 30000

Note:

CE Certification cost quoted per Intended use / technical File/construction/design.
Additional technical files are 25% discounted.
Travel & accommodation extra for a maximum of 3 man-days.

CALCULATE MDR CE CERTIFICATION COST

REQUEST FOR DETAILED MDR QUOTE WITH STATEMENT OF WORK

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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