- The responsibilities of the Person Responsible for Regulatory Compliance
- The impact that the new MDR will have on the role of the EU Authorised Representative
- What are the most important changes to the new MDR?
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here. Acorn Regulatory has published its first medical device regulations whitepaper. The whitepaper looks at a range of issues including: