Requirements and Implementation of the Medical Device Regulation for CE Marking training course
The Medical Devices Regulation is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
The Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as well as manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).
The course will give you an understanding of the key requirements, which will provide:
- Essential knowledge to understand Regulatory Affairs of medical devices in EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
- A basis to learn later about implementation of CE marking projects
You will then learn to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.
The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.