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A hand holding a sheet with an exclamation mark and a list, a red cross in the background. Symbolizing a Factsheet for the EU MDR.
Published: 2019/01/08 - Regulatory Affairs - by Cord Schloetelburg

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.
Published: 2019/01/08 - Regulatory Affairs - by Thorsten Prinz

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
Published: 2019/01/07 - Medical Software - Updated: 2019/11/28 - by 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
Published: 2019/01/07 - Regulatory Affairs - Updated: 2019/11/28 - by 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).

Published: 2019/01/04 - Regulatory Affairs - by Thorsten Prinz

Delegated Acts and Implementing Acts

Delegated acts and implementing acts are instruments of the European Commission to ensure the implementation of the EU MDR.

A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials
Published: 2019/01/04 - Clinical Affairs - Updated: 2019/11/28 - by Thorsten Prinz and Helene Kern

Medical Device Clinical Trials

Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification
Published: 2019/01/03 - Regulatory Affairs - by Cord Schloetelburg

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
Published: 2019/01/03 - Medical Software - by Thorsten Prinz

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.

Do you want faster market access of medical software?

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