Requirements of the Medical Device Regulation 2017/745 (MDR)
Online course available
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 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).
This course conveys key concepts of the European Medical Devices Regulation. All medical devices will need to undergo a Conformity Assessment Procedure based on the MDR requirements in order to be placed on the European Union market. You will gain understanding of the requirements stipulated within MDR.