Regulatory Affairs

EU Regulatory Affairs and Liability Risks of AI-based Medical Devices

Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.

CE roadmap for medical devices: What are the requirements for approval and what are the costs?

Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.

2020/12/14 - Regulatory Affairs - Cord Schloetelburg

The EU Medical Device Regulation (MDR): What is changing?

The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.

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.

[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: 2021/04/16 - 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: 2021/04/16 - 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.

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.

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).