Downloads - Guidance for your regulatory compliance

We are happy to share our knowledge with you when it comes to the regulatory compliance of medical devices and IVDs! Browse through our whitepapers and guides - and if you are looking for something that you can't find here, feel free to contact us

(Please note: The guide is only available in German. However, you can easily translate the PDF using standard online translation tools for better accessibility.)

We look forward to hearing from you!

Medical Device Regulation (MDR): Guide and introductory aid for manufacturers and suppliers

developed by VDMA HealthTech and Metecon

Contents

The MDR presents significant challenges for both medical device manufacturers and suppliers: increased transparency, new responsibilities, and stringent regulatory requirements demand a shift in thinking and closer collaboration.

This guide, developed in cooperation with VDMA HealthTech, provides practical insights to help you better understand MDR requirements and foster successful cooperation between manufacturers and suppliers.

Please note: The guide is only available in German. However, you can easily translate the PDF using standard online translation tools for better accessibility.

Download now and gain valuable insights!

"The Technical Documentation under the MDR"

4 Practical Guides for Adapting from MDD to MDR

The Technical Documentation under the MDR (1): Changeover of your existing products


Technical documentation - Practical guide to converting your existing products - Introduction

Content


A procedural model in 6 steps:
  • Organization of Your Products
  • Intended Purpose
  • Indication/Contraindication
  • Product Description
  • Classification
  • General Safety and Performance Requirements (GSPR)

Download part 1 (Completely free of charge)

"The Technical Documentation under the MDR (2): Successful GAP Analysis"


Technical documentation - Practical guide: gap-analysis of your technical documentation

Content

  • Analysis based on GSPR,
  • Detailed analysis of technical documentation, and
  • Post-market surveillance analysis

Download part 2 (Completely free of charge)

"The Technical Documentation under the MDR (3): Content Overview and Ideas for Structure"


Technical documentation - practical guide for an overview of content and ideas for structure

Content

  • Well-structured technical documentation in coordination with the Notified Body,
  • Relevant components of the technical documentation including examples

Download part 3 (completely free of charge)

"The Technical Documentation under the MDR (4): Closing Gaps and Post-Market Surveillance"


Technical documentation - Practical guide for closing gaps and PMS

Content

  • Closing Gaps,
  • Post-Market Surveillance, and
  • Detailed Update of the Technical Documentation

Download part 4 (Completely free of charge)

"The Technical Documentation under the IVDR"

Practical Guide for Adapting from IVDD to IVDR"

Cover of the white paper Technical documentation: How to successfully adapt from IVDD to IVDR

Content

  • Transition of Existing Products to IVDR: Development of a Procedural Model
  • Successful GAP Analysis of Your Technical Documentation with Tips for Tables and Checklists
  • Closing the Gaps: The Gaps are Identified. What's the Systematic Next Step?
  • Content Overview and Expert Input on Specific Topics
  • Post-Market Surveillance

Download now (Completely free of charge)