Subscribe now

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.

Head with Gear Wheels symbolizing AI (Artificial Intelligence) Head with Gear Wheels symbolizing AI (Artificial Intelligence)
Artificial Intelligence, Workshop - Online Event on June 22, 2021

Regulatory Affairs for AI Applications in Medical Devices

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

2020/12/16 - Post-Market-Surveillance - Cord Schloetelburg

Post market surveillance and vigilance of medical devices according to MDR

Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation requires manufacturers to systematically and actively collect information on product use after it has been placed on the European market.

2020/12/15 - Quality Management - Cord Schloetelburg

Quality management for medical devices: ISO 13485

The quality management system is an essential component of a medical device manufacturer. The European Medical Device Regulation (MDR) has increased the importance of quality management even further.

2020/12/11 - Safety - Cord Schloetelburg

Electrical Safety for Active Medical Devices: The IEC 60601-1 Standard

Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.

2020/12/10 - Technical Documentation - Cord Schloetelburg

Technical Documentation of Medical Devices According to MDR

Medical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.

2020/12/09 - Medical Software - Cord Schloetelburg

Medical apps or software: classification and approval as medical device

Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.

2020/12/08 - Clinical Affairs - Cord Schloetelburg

Clinical Evaluation of Medical Devices according to MDR

Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.

1 2 3 5