Requirements and Implementation of Regulation (EU) 2017/745
Two-day practical course
The requirements of the MDR have applied since 26 May 2021 to all medical devices sold in the EU. The aim of this Regulation is to harmonise the regulatory review and approval process for medical devices across all EU Member States and to increase patient safety.
On 15 March 2023, Regulation (EU) 2023/607 was formalised.
With this amending regulation, manufacturers of medical devices were granted more time to certify their devices. However, the extension of the transitional period is tied to clear conditions.
Many new and revised requirements raise questions—for example, the classification of medical devices, the evidence required for safety and performance, as well as the numerous changes affecting technical documentation, clinical evaluation, post-market surveillance (PMS), EUDAMED, UDI, and more.
Anyone working in the medical devices sector should know and understand the various hurdles of the MDR, as day-to-day work is based on this Regulation.
In this interactive seminar, you will learn the key requirements of the MDR and receive practical tips on how to implement them within your organisation.
- Content
- Legal framework
- Roles and obligations of economic operators
- Requirements for a Quality Management System (QMS)
- Requirements for a Risk Management System (RMS)
- Technical documentation for medical devices
- Classification of medical devices
- Clinical evaluation
- Conformity assessment procedures and CE marking
- Post-Market Surveillance (PMS)
- EUDAMED
- Person Responsible for Regulatory Compliance (PRRC) under Article 15
- Your Benefits
- You will receive an up-to-date overview of the regulatory landscape and the MDR requirements.
- You will understand how to implement the new requirements within your organisation.
- You will understand interdependencies and interfaces across departments and see the bigger picture.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Early-career professionals or career changers
- Regulatory Affairs professionals
- Risk Management specialists
- Project leads
- Staff from specialist departments who want to better understand the overall picture and interfaces with other functions
