VDE Medical Devices and Software

EU MDR Factsheet for Manufacturers of Medical Devices

Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.

A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition. A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition.

Transition Period of the EU MDR: What Dates Manufacturers Need to Know

The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.

Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards
2019/01/07 - Medical Software - Updated: 2021/04/16 - Thorsten Prinz

Harmonized Standards for Medical Software

Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.

European flag with scale symbolising CJEU European Court of Justice European flag with scale symbolising CJEU European Court of Justice
2019/01/07 - Regulatory Affairs - Updated: 2021/04/16 - Thorsten Prinz

CJEU Top Court Cases on Medical Devices

Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification

Medical Device Certification Based on the New EU MDR: a Step by Step Guide

Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.

Compass and a person working an computer, symbolizing Guidance for Medical Software Compass and a person working an computer, symbolizing Guidance for Medical Software

Guidance for Medical Software Companies

You have to do with medical software and feel lost in regulation? Don’t give up. Get guidance with our latest book.

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