Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR. Please Note: 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. Our previous MDR publications have drawn considerable interest from experts in the sector. This edition is the third in the series and the first to be published in 2020.  You can download your copy below. Now, with less than 6 months until MDR comes into force, companies need to focus on the issues that they need to complete to ensure that they continue to be able to supply their products.

Download your copy now

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Further MDR Reading from Acorn Regulatory

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.

Get The 1st 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. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper 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.