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PDF Free for Manufacturers & Suppliers

Practical Guide: MDR Requirements for Manufacturers and Suppliers

What does MDR require of manufacturers, and what does this mean for their suppliers? The guide, developed in collaboration with VDMA HealthTech, explains key requirements for quality management, development, risk management, and manufacturing from both perspectives and provides practical guidance for collaboration.

Here's what you can expect

Understanding the MDR from Two Perspectives

For each topic area, the guide explains what is relevant for manufacturers and suppliers, what documents are typically required, and what both parties should discuss:

  • Quality Management: What insights into the supplier’s processes does the manufacturer need, and what should a Quality Assurance Agreement cover?
  • Development and Design: How are requirements, design decisions, and testing methods coordinated early on?
  • Risk Management: How is information from production integrated with potential risk control measures?
  • Manufacturing: What information regarding materials, cleaning processes, and production conditions is needed for the manufacturer’s documentation?

This PDF is available only in German.

Authors:
Julian Raum, Expert in V&V & Technical Documentation, Metecon
Diethelm Carius, VDMA HealthTech

 

whitepaper-mdr-hersteller-lieferanten-metecon-vdma

 

Table of Contents

Four Areas Where Collaboration Takes Shape

Coordinate Quality Management

It is helpful for the supplier to have a certified quality management system. Nevertheless, the manufacturer must be able to understand and document which processes are relevant to its product. The guide explains the role that information exchange and a quality assurance agreement play in this context.

Clarify Design and Testing

Even if a supplier takes on development tasks, the manufacturer must evaluate and approve the results. Both parties should therefore establish early on what requirements apply and how compliance with them will be demonstrated.

Looking at Risks Together

Some risk control measures fall under the supplier’s manufacturing responsibilities. The guide explains why manufacturers and suppliers should discuss critical processes and appropriate evidence together.

Use Information from the Manufacturing Process

Operating and auxiliary materials, cleaning, and production conditions may be relevant to the evaluation of the medical device. Examples illustrate what information the manufacturer needs from the supplier for this purpose.

MDR Practical Guide for Manufacturers and Their Suppliers

Questions About the Guide and Download

Who is this practical guide intended for?

This practical guide is intended for medical device manufacturers and their suppliers, particularly those responsible for quality management, regulatory affairs, development, and manufacturing. It provides suppliers with an introduction to regulatory requirements and helps manufacturers explain the need for information and coordination in joint projects. It was developed in collaboration between Metecon and VDMA HealthTech.
How can manufacturers and suppliers use the guide together?

Use this guide as a basis for discussing the requirements, necessary documentation, and responsibilities specific to your product. Manufacturers can use it to explain their information needs; suppliers can determine which documents they need to provide and which questions still need to be clarified jointly. The guide serves as a starting point. Which specific requirements are relevant depends on the product and the tasks undertaken.
How do I get the practical guide?

Fill out the form on this page. You will then receive an email with a link to the PDF. You can download the guide, access it again later, and share it with your colleagues. If you don't receive the email, please check your spam folder.