IVDR CE Certification Cost

To obtain CE marking under the IVDR, manufacturers must demonstrate compliance with the relevant requirements and undergo a conformity assessment by a notified body. The specific requirements and procedures for obtaining CE marking may vary depending on the classification of the device and the applicable conformity assessment procedure.

It’s important to note that the IVDR introduces several new requirements and changes to the regulatory process for IVD devices, and manufacturers should familiarize themselves with the new regulations and seek guidance from a notified body or regulatory consultant like I3CGlobal to ensure compliance.

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Team I3CGLOBAL provides strategic guidance for IVDR CE Certification. Our professionals have the expertise and know-how to navigate EU 2017/746 regulations for small, medium, and large-scale manufacturers globally by supporting all stages of technical documentation.

We have the necessary manpower to accommodate as many projects as possible to meet customer deadlines. Our consultants work as an extension of your regulatory team.

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PRICING CALCULATOR

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

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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