Get The Acorn Regulatory Medical Device Regulations Whitepaper

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. We have produced our first medical device regulations whitepaper to look at the issues that will be faced by manufacturers and suppliers of medical devices.The whitepaper looks at a range of issues including:
  • 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.
The new regulations have widened the definition of what is actually a medical device and this change is bound to have significant impact on manufacturers.The whitepaper was published to coincide with 2019 Medtech Week.If you would like to receive a copy of the whitepaper please complete the form below and we will email a copy to you.
This is the first in a series of white papers on the subject to be published by Acorn Regulatory.

Be Prepared: Deadline 2020 – 2nd MDR Whitepaper

The Acorn Regulatory medical devices team, headed by 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?
Download it now.
About the Author

Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane

Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues. You can read medical device and related articles written by Bronwyn Kelly by clicking the link below.
Other articles by Bronwyn Kelly