MDRC logo
Home
Services ﹀
Clinical evaluation EU Authorized representative Notified bodies Post-market surveillance PRRC Quality management system Risk management Technical documentation
Devices﹀
General devices and equipment In vitro diagnostics Medical software
Articles About Contact us
German flag icon Russian flag icon
MDRC logo

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

Or use the contact form below

 
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 >>
German flag icon Russian flag icon

Risk management

Risk management is a fundamental component of the regulatory approval process for medical devices and is a critical aspect of ensuring patient safety and compliance with regulatory requirements. It is an ongoing process directed at identifying and addressing potential risks throughout the entire lifecycle of the medical device.

Risk management

Risk management is a fundamental component of the regulatory approval process for medical devices and is a critical aspect of ensuring patient safety and compliance with regulatory requirements. It is an ongoing process directed at identifying and addressing potential risks throughout the entire lifecycle of the medical device.

The risk management process involves the following key steps

1. Risk Identification Identifying and documenting poten- tial hazards and risks associated with the medical device and its intended use. This includes analysing possible failure modes, harm- ful events, and poten- tial consequences. 2. Risk Evaluation Assessing the severity of identified risks and the likelihood of those risks occurring. This evaluation helps prioritise risks based on their potential impact on patient safety and device performance. 3. Risk Control Implementing measures to reduce or control identified risks to an acceptable level. This may involve design modifications, safety features, warning labels, or changes in the device's instructions for use 4. Risk Benefit Analysis Balancing the potential benefits of the medical device against its identified risks to determine if the overall benefit-risk profile is favorable

Ensuring ISO 14971 Compliance

Obtaining CE-marking for your medical devices is a critical milestone for market access in the European Union. To achieve this, a robust risk management system that aligns with ISO 14971 standards is of utmost importance.

Regulatory authorities in the EU place significant emphasis on risk management when assessing medical devices for CE-marking. A well-documented and ISO 14971 compliant risk management system can expedite the CE-marking process by providing a comprehensive and transparent overview of how your organisation addresses potential risks.

Ensuring ISO 14971 Compliance

Obtaining CE-marking for your medical devices is a critical milestone for market access in the European Union. To achieve this, a robust risk management system that aligns with ISO 14971 standards is of utmost importance.

Regulatory authorities in the EU place significant emphasis on risk management when assessing medical devices for CE-marking. A well-documented and ISO 14971 compliant risk management system can expedite the CE-marking process by providing a comprehensive and transparent overview of how your organisation addresses potential risks.

Let us support you in developing an ISO 14971 compliant risk management system that sets you on the path to success in the medical device industry.

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.