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info@mdrc-services.com

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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 >>
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Seamless Certification by a Notified Body

When a medical device manufacturer seeks to place their product on the EU market, the majority of products must undergo a thorough conformity assessment process conducted by a Notified Body, an independent organisation designated by an EU member state to assess the compliance of medical devices with the applicable regulations.

Seamless Certification by a Notified Body

When a medical device manufacturer seeks to place their product on the EU market, the majority of products must undergo a thorough conformity assessment process conducted by a Notified Body, an independent organisation designated by an EU member state to assess the compliance of medical devices with the applicable regulations.

Streamlined communication with EU Notified Bodies will facilitate regulatory approvals for your medical devices. However, managing the interaction with EU Notified Bodies can be complex and time-consuming.

That's where we step in to assist you. We have a deep understanding of the regulatory requirements and expectations of EU NBs. We act as the bridge between your company and the NBs, streamlining the communication process and ensuring efficient interactions.

Contact us right now

We will support you during:

We will guide you through the audits, ensuring a smooth and successful certification and pathway to gaining market access in the EU.

Get in touch

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 information

CE-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 >>


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.

Send us an email:
info@mdrc-services.com

Or use the contact form below

 

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.