European flag with scale symbolising CJEU European Court of Justice
Published: 2019/01/07 - Court Decision - 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 - Law - 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 - Guidance - Updated: 2019/06/07 - 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 - Guidance - 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 - Guidance - 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.

A label with an hourglass, a factory, an umbrella, a thermometer, a barcode and a qr code on it, symbolizing UDI-compliant labelling of medical devices
Published: 2019/01/01 - Workshop

March 26: UDI compliant labeling of medical devices

Learn in our workshop how to introduce a system of UDI unique device identification for the traceability of medical devices as a project in your company.

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