Implementation of the MDR for CE Marking
The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation.
Course objective and outcome
The objective of this course is to help implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product. The CE mark gives access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing medical devices 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.
This course aims to offer guidance on implementation of the requirements stipulated in the MDR. The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation. Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own.
The Medical Devices Regulation (MDR) 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 will 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 MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post market surveillance (PMS), transparency and traceability. The requirements will also affect (supplier) audits and governmental control, introduce new partners to interact with, and increase communication needs and obligations (e.g. contracts, reporting, documentation, and publication of information).
Who should attend
- RA, QM, and QA professionals who need to implement the MDR
- Personnel concerned with certification or active in projects for CE marking
- Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, authorized representative, importer, distributor, auditee
This course is a next step for those participants who have already attended Medicoindustrien’s course “MDD to MDR Transition”.
Marco Rost – BSI Tutor