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How to obtain CE marking for medical software under the EU MDR or IVDR?

Medical Device Software (MDSW) refers to software applications that are an integral part of a medical device or intended for use in the diagnosis, monitoring, treatment, or prevention of diseases. These software systems play a crucial role in modern healthcare, facilitating tasks such as data analysis, image processing, treatment planning, and more.


However, due to their critical impact on patient safety and health outcomes, MDSW is subject to rigorous regulatory requirements to ensure their reliability, accuracy, and compliance with medical standards. This includes adherence to the European Union's Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for devices marketed in the EU. Understanding and meeting these regulatory standards is essential for manufacturers and developers of MDSW and necessary for obtaining the CE-marking demonstrating product's regulatory compliance.

Requirements for medical software and the manufacturer seeking the CE-marking

The essential compliance criteria are similar to those for any other medical device under the EU MDR or any in-vitro diagnostic device under the IVDR. Here's a concise overview:



  1. Comprehensive technical documentation as outlined in EU MDR or IVDR Annex II. This documentation should furnish evidence of adherence to the General Safety and Performance Requirements (GSPR, as enumerated in Annex I), and Annex III for post-market surveillance. The central proof of GSPR compliance should be rooted in conformity with the EN 62304 standard on medical device software lifecycle management.
  2. A robust quality management system, as stipulated in EU MDR or IVDR Article 10 at the very least. For device classes that necessitate Notified Body certification, an EN ISO 13485 compliant quality management system is a prerequisite.
  3. A Person Responsible for Regulatory Compliance (PRRC), in accordance with EU MDR or IVDR Article 15. the PRRC serves as a crucial bridge between the company's operations and the regulatory environment, ensuring that all activities related to medical device manufacturing and distribution align with the applicable laws and standards.
  4. For manufacturers situated outside of the EEA, an EU Authorized Representative is required, as stipulated in EU MDR or IVDR Article 11.
  5. Assignment of Unique Device Identification (UDI). Assigning a UDI to a medical device involves obtaining a unique code from a UDI issuing agency, which is responsible for managing and maintaining the UDI system. This code is then encoded into a barcode or a data matrix, which is physically marked on the device label or packaging.
  6. EUDAMED registration, which mandatory for medical device manufacturers aiming to market their products within the European Union. It involves submitting information about the device, its specifications, intended use, and more, to the European Databank on Medical Devices. This centralized database helps regulatory authorities monitor and regulate medical devices in the EU market.
  7. Certification by a Notified Body, for medical software other than Class I under the EU MDR or Class A under the IVDR. A Notified Body is an independent organization designated by an EU member state to assess and verify the conformity of medical devices with the applicable regulatory requirements.

In conclusion, navigating the regulatory landscape for Medical Device Software (MDSW) is a multifaceted endeavor that demands meticulous attention to detail and a thorough understanding of the EU MDR and IVDR. Adhering to the outlined requirements, including robust quality management systems, comprehensive technical documentation, and the appointment of a Person Responsible for Regulatory Compliance (PRRC), is paramount. Additionally, the assignment of a Unique Device Identification (UDI), EUDAMED registration, and certification by a Notified Body further underscore the rigors involved. By diligently following these steps, manufacturers of MDSW can confidently pursue CE marking, ensuring their products meet the highest standards of safety, quality, and performance in the European market and beyond. This diligent adherence to regulatory standards not only facilitates market access but also upholds the integrity of patient care and medical innovation.

Here is what you need to get your medical device software CE-marked:

Technical documentation
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Quality
management
system
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PRRC

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Authorized
representative
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UDI

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EUDAMED
registration
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Notified
body
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We will help you obtain all the necessary certificates.

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How to obtain CE marking for medical software under the EU MDR or IVDR?

Medical Device Software (MDSW) refers to software applications that are an integral part of a medical device or intended for use in the diagnosis, monitoring, treatment, or prevention of diseases. These software systems play a crucial role in modern healthcare, facilitating tasks such as data analysis, image processing, treatment planning, and more.


However, due to their critical impact on patient safety and health outcomes, MDSW is subject to rigorous regulatory requirements to ensure their reliability, accuracy, and compliance with medical standards. This includes adherence to the European Union's Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for devices marketed in the EU. Understanding and meeting these regulatory standards is essential for manufacturers and developers of MDSW and necessary for obtaining the CE-marking demonstrating product's regulatory compliance.

Requirements for medical software and the manufacturer seeking the CE-marking

The essential compliance criteria are similar to those for any other medical device under the EU MDR or any in-vitro diagnostic device under the IVDR. Here's a concise overview:



  1. Comprehensive technical documentation as outlined in EU MDR or IVDR Annex II. This documentation should furnish evidence of adherence to the General Safety and Performance Requirements (GSPR, as enumerated in Annex I), and Annex III for post-market surveillance. The central proof of GSPR compliance should be rooted in conformity with the EN 62304 standard on medical device software lifecycle management.
  2. A robust quality management system, as stipulated in EU MDR or IVDR Article 10 at the very least. For device classes that necessitate Notified Body certification, an EN ISO 13485 compliant quality management system is a prerequisite.
  3. A Person Responsible for Regulatory Compliance (PRRC), in accordance with EU MDR or IVDR Article 15. the PRRC serves as a crucial bridge between the company's operations and the regulatory environment, ensuring that all activities related to medical device manufacturing and distribution align with the applicable laws and standards.
  4. For manufacturers situated outside of the EEA, an EU Authorized Representative is required, as stipulated in EU MDR or IVDR Article 11.
  5. Assignment of Unique Device Identification (UDI). Assigning a UDI to a medical device involves obtaining a unique code from a UDI issuing agency, which is responsible for managing and maintaining the UDI system. This code is then encoded into a barcode or a data matrix, which is physically marked on the device label or packaging.
  6. EUDAMED registration, which mandatory for medical device manufacturers aiming to market their products within the European Union. It involves submitting information about the device, its specifications, intended use, and more, to the European Databank on Medical Devices. This centralized database helps regulatory authorities monitor and regulate medical devices in the EU market.
  7. Certification by a Notified Body, for medical software other than Class I under the EU MDR or Class A under the IVDR. A Notified Body is an independent organization designated by an EU member state to assess and verify the conformity of medical devices with the applicable regulatory requirements.

In conclusion, navigating the regulatory landscape for Medical Device Software (MDSW) is a multifaceted endeavor that demands meticulous attention to detail and a thorough understanding of the EU MDR and IVDR. Adhering to the outlined requirements, including robust quality management systems, comprehensive technical documentation, and the appointment of a Person Responsible for Regulatory Compliance (PRRC), is paramount. Additionally, the assignment of a Unique Device Identification (UDI), EUDAMED registration, and certification by a Notified Body further underscore the rigors involved. By diligently following these steps, manufacturers of MDSW can confidently pursue CE marking, ensuring their products meet the highest standards of safety, quality, and performance in the European market and beyond. This diligent adherence to regulatory standards not only facilitates market access but also upholds the integrity of patient care and medical innovation.

Further reading

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it

EUDAMED registration - a brief guide

Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)

GSPR – General Safety and Performance Requirements for medical devices in the European Union

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

IEC 62304 - the pivotal standard for software medical devices

Medical Device Regulation (MDR) - basics

ISO and IEC standards for medical device software

Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle

Notified Bodies and their role in certification of medical devices

What is NANDO and why medical device companies should know about it?

Labeling and UDI requirements for medical devices in the EU

Understanding the roles of Authorised Representatives and Importers under MDR/IVDR

MDR implementation - challenges and solutions

Post-market surveillance under MDR and IVDR - requirements and best practices

Notified Body audit - a manufacturer's guide

Risk management plan - guide for medical device companies

Should my medical device comply with GDPR?

EC-certificate for a medical device - Q&A

How long does it take to CE-mark a medical device?

What is a PRRC?

Essential requirements for importers and distributors under MDR and IVDR

Language requirements for IFUs and labels under the MDR and IVDR

Legal Manufacturer and Original Equipment Manufacturer in medical devices

How to structure a PRRC contract for effective compliance

How to Create a Declaration of Conformity According to MDR or IVDR

All articles >>

Get in touch

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

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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 >>


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Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

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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 >>

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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.
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