Medical Device Regulation Overview
This course provides an overview of European Medical Device Regulation and the implications for company’s organizations.
Since the 1990s, regulation of the medical device industry in Europe has remained relatively unchanged. Recent incidents, including the breast implant crisis and the hip replacements, prompted urgent regulatory and compliance reforms to the Medical Device Industry. Among the most significant of these are the European Commission’s 2012 proposals for regulation on medical devices (EU MDR) and in-vitro diagnostics (EU IVDR).
National regulators exert more control and oversight of the medical devices industry—with adoption mandatory. Companies can lose their license to operate if they fail to comply with these upcoming changes.
Medical Device Market
Manufacturers producing medical devices for the EU market today, and who want to continue supplying those devices beyond 2020, must comply with the new EU MDR. Most of the new requirements are really extensions to already existing requirements. In the majority of cases, these new requirements simply bring the EU regulations up to date with the medical device requirements in the rest of the world.
Unique Device Identification or UDI is the bar-coding of all medical devices on the European market using a standard format. A database provides users and regulators quick access to information about the coded device.
The requirements for device classification in the new European Medical Device Regulation (EU MDR) are essentially the same as those in the current Medical Device Directive (MDD)
Why This Training?
The impact of this regulation can dramatically alter the operations of medical device manufacturers. It can even impact the composition of their existing as well as future portfolios. Cost of compliance is most likely significant. It is critical that
businesses take action now—to gain stakeholder buy-in, prepare their organisations, and start implementing changes.