MDR Basics

The EU legislation on medical devices has always been intended to ensure that devices are safe and deliver clinical benefits. When both manufacturers and notified bodies failed to ensure that as a result the new Regulation (EU) 2017/745 (MDR – Medical Device Regulation) has been published. MDR sets out the requirements for all the interested parties – manufacturers, distributors, notified bodies and authorities.

MDR is quite a complex environment, which may be difficult for a professional new to the topic to navigate. Meeting MDR requirements and obtaining certification for the medical device are placing a huge administrative, legal & cost burden on manufacturers. Therefore, it is critical for legal manufacturers to have competent personnel knowledgeable about medical device regulation, so the company does not lose out and can put its devices on the market.

The training aims to serve as a low-detail map for professionals new to the topic and as a starting point for further in-depth learning of all the requirements relevant to their medical devices.

Key Topics Covered:

·       Why is there an MDR? What is the main purpose of MDR?

·       How is MDR structured?

·       What are the requirements for legal manufacturers?

·       Qualification and classification of medical devices

·       Conformity assessment routes

·       Requirements on medical devices and technical documentation

By the end of this training, participants will be able to:

·       Understand the context of MDR

·       Understand the key obligations for MedTech companies under MDR

·       Navigate through MDR and guiding documents

·       Know where to look for requirements on the quality management system and medical devices

·       Understand the process of conformity assessment

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Regulatory Affairs, Quality Management, Clinical Affairs, Product Managers with no to low knowledge of MDR

Trainer: Irenej Polacek