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.
The news of a proposed delay in the date of application of the MDR by one year coming from the Commission in recent days is being welcomed by many across the medical devices sector which have been under intense pressure to prepare for implementation of MDR in May 2020.
The full text of the European Commission proposal has been published today and can be read by clicking here.
Notified Body Delays
There have been delays across the board in terms of Notified Body capacity, progress on various guidance documents and implementing acts and it has certainly limited the ability of manufacturers and other economic operators in making effective preparations for MDR implementation.
Our understanding from various sources in the sector is that the intent of the proposal is to allow the medical devices sector – industry, notified bodies and competent authorities- to devote its resources and efforts in addressing the challenges presented by Covid-19. There has been some speculation as to whether the proposed delay will mean that Article 120 (3) requirements around vigilance, for example, will be pushed out by 12 months, and what the implication would be for Article 122 on the repeal of the directive. Until the text of the proposal is published, any subtleties or nuances in how the proposed delay would be managed remain to be seen.
We will share updated information as it becomes available. In the meantime, until the detail becomes clear and any proposals are formally adopted by the European Parliament, our advice is to continue with preparations for MDR. Whether we are now 55 days from the date of application or a little longer, there remains much work to be done to be ready.
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.
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.