If you produce medical devices, you’re probably aware that in 2017, the European Parliament released a new set of regulations regarding both medical devices and in vitro medical devices. In short, the MDR and the IVDR – Medical Device Regulations and In Vitro Device Regulation – enforced a stricter set of demands for the manufacturing and distribution of these products within the European Union. This timeline template illustrates how MDR and IVDR will be adopted and the transition periods to help you prepare for the new requirements.
The changes adopted in the new legislature have the role of increasing consistency in the documentation, reclassifying the devices in accordance with the risks involved and delineating the supervision bodies responsible for each class. The MDR and IVDR are also more extensive in scope compared to the older regulations and now cover genetic testing and exams that reveal a patient’s predispositions to certain conditions. Lastly, a unique device identification paired with the removal of grandfathering provisions will force manufacturers to follow these strict guidelines for all devices made available to the public.
The MDR & IVDR timeline was created using Office Timeline PowerPoint add-in, an incredibly intuitive but also powerful timeline maker, and is free to download as a PowerPoint template. Give the free version a go and create an outline of your next steps to obtain and maintain your MDR certifications. Or get the Pro Edition and access import features and numerous swimlane templates to transform a complex batch of data into that visually appealing and easily digestible graphic your stakeholders will appreciate.