Resources - Article 10a

How Can an Article 10a Decision Tree and Worksheet Simplify Your Path to Compliance?

Article 10a Decision Tree and Worksheet

Download the Article 10a Decision Tree and Compliance Assessment Worksheet to streamline your MDR/IVDR readiness with actionable steps and tools. Download Now>>

[Download the Complete Guide to Article 10a Compliance and Mastery]

Guidance

Regulation (EU) 2024/1860

Published in the official journal on July 9, 2024, and the amendments to the MDR and IVDR apply as of January 10, 2025. Read more>>

MDCG 2024-16

The form that manufacturers can use to submit information regarding the supply interruption or discontinuation to the competent authority. Read more>>

MDCG 2024-16 Annex

A useful table that manufacturers can use to list the devices in question. Read more>>

Q&A Document Revision 1 (EC)

Provides more information and can be found alongside the MDCG documents on the EC Commission website. Read more>>

Articles

Legacy Device Manufacturers and Article 10a: A Practical Guide

Legacy device manufacturers face new obligations under Article 10a of the EU MDR and IVDR. Compliance is critical to avoid regulatory pitfalls—this guide breaks down the requirements and how to navigate them effectively. Read more>>

Quality Management Systems and Article 10a: Ensuring Compliance

Article 10a under the EU MDR and IVDR requires manufacturers to update their quality management systems (QMS) to manage risks and ensure compliance. Learn how Article 10a impacts QMS and the steps you need to take. Read more>>

Economic Operators and Article 10a: What You Need to Know

Article 10a introduces significant responsibilities for economic operators, including importers, distributors, and authorized representatives. Understand how these roles impact the supply chain and how to prepare. Read more>>

What Notified Bodies Need to Know About Article 10a

Notified bodies face new responsibilities in assessing compliance under Article 10a of the EU MDR and IVDR. Discover the key requirements and how NBs can support manufacturers while safeguarding public health. Read more>>