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.

Acorn Regulatory has published its first medical device regulations whitepaper.  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
  • What are the most important changes to the new MDR?

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 has been published to coincide with Medtech Week.

If you would like to receive a copy of the whitepaper please complete the webform below and we will email a copy to you.

We have written extensively on the MDR issue.  If you would like to stay up to date on what is happening with the new medical device regulations, then you should subscribe to the Acorn Regulatory monthly newsletter.  You can subscribe to the newsletter here.

This is just one of a number of publications released by Acorn Regulatory on a range of regulatory, PV and clinical issues.  Why not download some of our other publications:

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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