2nd MDR Whitepaper: Get An Advance Copy

We will be publishing our 2nd MDR whitepaper ‘Be Prepared’ in October.  You can sign up to receive a copy before it is available on general release.  The second whitepaper will look at 5 areas that will impact device manufacturers and distributors.

2nd MDR whitepaper from Acorn Regulatory

‘Be Prepared’ will look at issues such as:

  • Overview of UDI (Unique Device Identifier system)
  • Quality Management System under MDR
  • An overview of Eudamed
  • Clinical investigations under MDR
  • Clinical evaluations under MDR

MDR has been dogged by issues, particularly the delay in appointing Notified Bodies. Italy’s IMQ became the fourth Notified Body to be appointed (along with DEKRA, TUV SUD and BSI) in recent weeks. The pace of appointing NB’s has alarmed some in the industry and has led to calls for the delay to the implementation of MDR in May 2020.  Despite the clamour to delay implementation, the date has not yet changed and MDR will come into force on May 26th 2020. Companies need to be ready.

Sign up to receive your advance copy of the 2nd MDR whitepaper by completing the form.  Also, below, you can find the details of our medical devices team should you need to contact them to discuss any MDR related issues that your company might have.

Do You Have MDR related Issues?

If so, contact Orla Keane, Acorn Regulatory’s Medical Devices Manager at 00353 52 61 76 706 or email: info@acornregulatory.com

Meet our Medical Devices Team

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