MDR Delay -Will It Be Postponed?

The Covid-19 crisis has impacted every facet of modern life.  The life sciences sector has been at the centre of the crisis as companies have sought to develop a vaccine and ensure that essential supplies are available to those who need then.  The scheduled introduction of the new medical device regulations is now in doubt as the European healthcare and life sciences sector scramble to manage the Coronavirus crisis.  The possibility of an MDR delay looms large at present.  Read more to find out the latest on the issue. 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. We have been at the forefront of the MDR issue for a considerable amount of time.  We can assist your company with any MDR related issues.  Get in touch with us by calling us on 00353 52 61 76 706 or by completing the form below. [ninja_form id=1]

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 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

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 the course of our interactions with these clients, there are many topics that are being raised time and again. Read more here.