Regulatory Affairs

A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps. A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps.
2019/06/13 - Regulatory Affairs - Thorsten Prinz

[Video] How to Achieve MDR Compliance for Medical Apps

It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.

A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets . A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Regulatory Affairs - Updated: 2020/01/06 - Janine Manke and Daniel Kendziur

Trade Secrets: Protect Your Intellectual Property

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability . A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability .
2019/01/11 - Regulatory Affairs - Updated: 2019/11/28 - Thorsten Prinz and Michael Ankele

Traceability of Medical Devices

Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

2019/01/08 - Regulatory Affairs - 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. A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition.
2019/01/08 - Regulatory Affairs - 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.

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: 2019/11/28 - 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).

2019/01/04 - Regulatory Affairs - 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.

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
2019/01/03 - Regulatory Affairs - 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.