Get The Acorn Regulatory Medical Device Regulations Whitepaper
- 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
- and most importantly, the medical device regulations whitepaper will look at what actually constitutes a medical device.
This is the first in a series of white papers on the subject to be published by Acorn Regulatory.Orla Keane, has looked at the major issues that will impact on device manufacturers and suppliers.In our first whitepaper, released earlier this year, they looked at the role of the Person Responsible for Regulatory Compliance and the enhanced role of the EU Authorised Representative.Now, in the second MDR whitepaper they look at further issues that will impact upon companies preparing for the new MDR. Again, they have considered the ‘hot topics’ from the clients that they have been working with and questions submitted to them through the Acorn Regulatory website.In this edition they look at:
- The role of Eudamed under MDR
- Post Market Surveillance
- What will happen to UDI’s under MDR?