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.

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.

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 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.

Further Reading on MDR

A Guide to Drug Device Combination Products

We have produced a drug device guide that looks at the issue.  It also considers the issue in relation to the changes for drug device combination products in relation to the Medical Device Regulations.  You can download the guide here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.

About the Author

John Seekings
Medical Devices Manager
John Seekings manages the Acorn Regulatory medical devices team. He is an experienced device expert having spent over 20 years in the sector working with companies in Ireland, the UK, Germany, Switzerland and elsewhere.
Contact John

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