All medical devices placed on the European internal market must comply with the European Medical Devices Regulation (EU-MDR). This also applies to medical devices that have been on the market for years before this legislation came into effect. During the Medical Devices Regulation (MDR) training (2017/745/EU), you will be informed about the most important rules. These rules affect healthcare providers, notified bodies, manufacturers, importers, distributors, and service providers of medical devices.
- Get acquainted with classification rules, quality management systems (QMS), and conformity assessment routes
- Discover the requirements for technical documentation, post-market surveillance, clinical investigations, and risk management
- Gain insight into the role of Notified Bodies
About the training Medical Devices Regulation
The MDR (Medical Device Regulation) is the successor to the MDD (Medical Device Directive). The MDR outlines a renewed framework for the quality of medical devices with the aim of ensuring safety during use. Additionally, it is valuable that patients and healthcare providers can easily access adequate information about the devices thanks to the new regulations, enabling them to make well-informed decisions about their deployment and use.
All existing requirements from the MDD are included in the MDR, but new requirements have also been added. Within the MDR, a distinction is made between different risk classes of medical devices. The higher the risk to the patient/client if the medical device fails, the higher the risk class of the device. The stricter the requirements imposed on this device from the MDR are for both pre-market and post-market entry.
Program
- Background of the MDR
- Domain and definitions of the MDR
- Classification rules
- Quality management systems (QMS)
- Conformity Assessment Routes
- GSPR (General Safety and Performance Requirements)
- Technical documentation and requirements
- Clinical evidence and investigation process
- Post-market surveillance (PMS)
- Post-market clinical follow-up (PMCF)
- Incident monitoring and corrective actions (vigilance)
- Risk management
- Identification through the European Database on Medical Devices (EUDAMED)
- Traceability through Unique Device Identification (UDI)
- Transition and next steps
- Business impact, timeline, and portfolio planning
- The role of notified bodies, competent authorities, and the European Commission
Place, dates and prices - Open registrations
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Mikrocentrum uses all-inclusive rates. All mentioned rates are exclusive of VAT and include course materials and package costs.
Members of the Mikrocentrum High Tech Platform get a 10% discount.
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination with your company-specific situation and the deployment of highly experienced lecturers who have earned their spurs in practice is essential here. Mikrocentrum is CEDEO-recognized and guarantees the best quality.
Our training manager is happy to think along with you!
Are you interested in an incompany process? Our training manager Barend Blom will be happy to visit you without obligation.