Do you know which guidelines your medical product needs to comply with? After completing the training on CE marking of medical devices, you will be able to confidently bring products to the European internal market (EU). You will learn about the roles of stakeholders, essential safety and performance requirements in relation to harmonized standards, product classification, and the possible assessment routes. Post-market requirements and increasing obligations for the distribution chain will also be covered.
- Bring your products to market faster and reduce risks and costs
- Learn to develop your own product correctly and optimally the first time
- Ensure your design complies with European Directives from the outset
About the training on CE marking of medical devices
Obtaining CE marking for medical devices is a complex and evolving process. If you want to bring medical devices to market, they must meet safety, quality, and guaranteed functional requirements. The CE Marking of Medical Devices course will guide you through recent regulations and help you determine the most optimal route to compliance.
Medical devices in compliance with the MDR
Medical devices compliant with the Medical Device Regulation (MDR) must bear a CE mark. This mark is placed on the device itself or, if required, on its sterile packaging. If placement on the device is not feasible due to its type, the CE mark is placed on the packaging. Additionally, the CE mark must appear in the device's instructions for use and on its sales packaging. If a notified body has conducted the conformity assessment, the CE mark is followed by the identification number of the notified body. CE marking does not apply to custom-made devices or devices intended for research purposes.
Program
- The structure of European directives and regulations for medical devices
- Responsibilities of the manufacturer, notified bodies, and the Ministry of Health, Welfare, and Sport (VWS)
- Selection and interpretation of relevant standards
- Relationship between directives, EN ISO 13485, ISO 14971, and clinical performance (MEDDEV 2.7.1)
- Classification rules
- Possible routes to CE marking of medical products
- Necessary collaboration with a notified body
- Setup and maintenance of a technical file/design dossier
- Requirements for clinical evaluation (MEDDEV 2.7.1)
- Practical aspects of bringing and maintaining a medical product on the market
- Language requirements, product changes, and supervision of incidents and corrective actions
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.