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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance

General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)

CE-marking process for medical devices CE-marking process for in vitro diagnostics PRRC under MDR or IVDR Checklists >>

CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

In vitro diagnostics (IVD)

We assist in vitro diagnostics companies manufacturing products of all risk classes in obtaining CE marking under the In Vitro Diagnostic Medical Device Regulation (IVDR).

In vitro diagnostics (IVD)

We assist in vitro diagnostics companies manufacturing products of all risk classes in obtaining CE marking under the In Vitro Diagnostic Medical Device Regulation (IVDR).

Our services cater to various types of in vitro diagnostic products, such as:

immunoassay kits

molecular diagnostic tests

point-of-care testing (POCT) devices

clinical chemistry analysers

hematology analysers

hematology analysers

coagulation analysers

microbiology culture systems

flow cytometers

urinalysis analysers

serology test kits

general laboratory equipment

We provide support throughout the entire CE certification process. Our services cover a wide range of in vitro diagnostic products of all classes. We assist in the preparation and compilation of all necessary technical and QMS documentation required for your IVD products.

Contact us today to learn more about our CE marking services for in vitro diagnostics under IVDR.

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We're ready to help you. Contact us whether you have a question about our solutions or need help with regulatory issues

Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com

			©2025 MDRC - Medical Devices Regulatory Compliance

			Solutions
			EU Authorised Representative (EC REP)

			PRRC

			Technical documentation

			Risk management

			Clinical evaluation

			Notified bodies

			Quality management system

			Post-market surveillance system

			Your products
	    Medical devices and medical equipment

		In vitro diagnostic medical devices

		Medical software

		Resources
		Medical Device Regulation (MDR) - basics

		CE-marking process for medical devices

     	CE-marking process for in vitro diagnostic medical devices

     	UDI infographic

     	EUDAMED registration step by step instruction

     	Checklists
		MDR technical documentation checklist

		IVDR technical documentation checklist

	   	Technical documentation checklist for medical device software (MDSW)

		MDR-compliant quality system documentation checklist

		Clinical Evaluation Plan checklist

		Clinical Evaluation Report checklist

All checklists >>

Useful informationCE-Certificate vs. EC-Certificate
Basic UDI-DI (bUDI) 
EUDAMED registration - a brief guide
Authorised Representative Mandate
GSPR – General Safety and Performance Requirements
How to obtain CE marking for medical software under the EU MDR or IVDR?
Technical documentation for Medical Device Software in the EU
Read more >>

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We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
 We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.