CE Certification Cost

CE Certification cost 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.

The increased requirements and changes introduced by the MDR have led to an increase in the 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 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. Check out our affordable CE Certification cost in below table.

CE Certification Cost Based on Risk Class

MDR CLASS I

		Regular	Premium
1	Prepare Technical Documentation as per Annex II and III , Article 10, Clause 4	X	X
2	Clinical Evaluation Report Documentation	–	X
3	Post Market Surveillance and PSUR	–	X
		$ 5000	$8000
4	European Authorized Representative	€ 850 / Year

⊗ A bulk discount of 30% is applicable for three or more technical documentation projects starting simultaneously

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

⊗ Fees will add up with addition of Models and variants. The approximate fee addition would be 500 USD

⊗ A bulk discount of 30% is applicable for three or more technical documentation projects starting simultaneously

⊗ An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within 04 months.

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

⊗ Fees will add up with addition of Models and variants. The approximate fee addition would be 500 USD

⊗ A bulk discount of 30% is applicable for 03 or more technical documentation projects starting simultaneously

⊗ An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within 05 months.

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

⊗ Fees will add up with addition of Models and variants. The approximate fee additioan would be 1000 USD

⊗ A bulk discount of 20% is applicable for 03 or more technical documentation projects starting simultaneously

⊗ An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within 05 months.

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 Authorised Representative (Optional)	€ 1350 / Year
9	EUDAMED (Actor + SRN) (Optional)	€ 600
10	Biocompatibility Testing (If Applicable)	Request for Quote
11	Electrical Safety Testing (If Applicable)	Request for Quote
12	Drug Master File (If Applicable)	$9000 (Partial) $16000 (Full)
13	Ancillary Medicinal Substance (If Applicable)	$6000 additional
14	Accessories to Active device (If Applicable)	€ 1000 / accessories
15	Notified Body Fees / Technical File (reference purpose only).	€ 30000

⊗ Fees will add up with addition of Models and variants. The approximate fee addition would be 1500 USD

⊗ A bulk discount of 20% is applicable for 03 or more technical documentation projects starting simultaneously

⊗ An additional discount of 10% will be provided if customer coordination with the consulting team is excellent and the technical documentation is uploaded to the Notified Body within 05 months.

General Information

⊗ If we need to meet onsite for critical discussions, travel and hotel costs are billed at cost and are limited to a maximum of three days (Consultants travel from Germany, India, Malysia, UK, USA)

⊗ Implementation services for EN ISO 13485 / IEC 62304 are available upon request and shall be subject to additional service fees

CALCULATE MDR CE CERTIFICATION COST

REQUEST FOR DETAILED MDR QUOTE WITH STATEMENT OF WORK

How to calculate Notified Body Fees?

#	Description of Activity	Charges (Euros)
1	MDR/IVDR Technical Documentation Review Includes Clinical Evaluation. Dependent on risk class and file quality. (Avg. 32 hours required).	250 to 600 (per hour)
2	Medical Device QMS (EN ISO 13485) Onsite Audit Travel & Lodging extra. Auditor travel time: 125 to 175 per hour. Client to organize stay/convenience.	250 to 300 (per hour)
3	Certification Charges Includes printing and dispatch.	1,500 (fixed)
4	Unannounced Audit Once during certification tenure or for vigilance issues.	5,000 to 7,000

***Source of Information: Notified Body Websites

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