Update on EU MDR Harmonized Standards: Ensuring Compliance and Safety

Introduction

The European Commission recently issued an important update to the Harmonized Standards incorporated within the EU Medical Device Regulation (MDR) on July 4, 2023. This regulation update, known as Implementing Decision (EU) 2023/1410, introduces modifications to the existing inclusion of EN ISO 25424 and adds a new standard, EN ISO 10993-10. In this article, we will delve into the amendments made and their implications for medical device manufacturers.

Understanding the Amendments

Implementing Decision (EU) 2023/1410 includes the following changes:

1. Replaced Entry:

   – Previous Entry No. 5: EN ISO 25424:2019

   – Replacement Entry: EN ISO 25424:2019/A1:2022

   – Scope: Sterilisation of healthcare products – Low temperature steam and formaldehyde – Requirements for development, validation, and routine control of a sterilization process for medical devices (ISO 25424:2018)

2. New Entry:

   – Entry No. 17: EN ISO 10993-10:2023

   – Scope: Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Impact for Manufacturers

This decision emphasizes the EU MDR’s primary focus on safety. While the previous Medical Device Directive (MDD) provided more guidance on registration and marketing, the MDR places a stronger emphasis on risk management, reporting, and product quality throughout the entire lifecycle of a medical device. Manufacturers should assess the applicability of these revised standards to their product lines and conduct gap assessments to evaluate any potential impact. Identifying gaps is crucial, as they may influence compliance with General Safety and Performance Requirements (GSPRs), both for existing products and those under development.

Achieving Compliance

Compliance with harmonized standards grants manufacturers a presumption of conformity with the EU MDR. Once the references of these standards are published in the Official Journal of the European Union, the presumption of conformity is established from the publication date. As a result, manufacturers can leverage the amended harmonized standards for sterilization of healthcare products and biological evaluation of medical devices in their product development and assessment processes.

Moving Forward

Staying up-to-date with industry changes can be a challenging task. At MedLark, we understand the importance of effectively managing regulatory updates. We offer comprehensive services such as gap assessments and development of regulatory intelligence programs to alleviate the burden on your team. Visit our webpage to learn more about how we can assist you. Stay informed about the latest regulatory news by subscribing to our newsfeed below.

Conclusion

It is essential for medical device manufacturers to grasp the implications of these changes to ensure compliance and maintain product safety. By adhering to the revised standards, manufacturers can navigate the regulatory landscape and provide safe and effective medical devices to the European market.