MDR Delay: Regulations Delayed Until May 2021
The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic. The European Parliament has now voted to formalise the delay and to suspend introduction of MDR until May 2021.
Firstly, you will see that some of our comprehensive MDR content that we have created since 2018 refers to the May 2020 date of application. Recent developments, as referenced above, means that the date of application has now 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.
MDR Delay: Parliament Vote
The European Parliament’s vote on April 17th, 2020 (by 693 in favour of a delay with 1 against and 2 abstentions) must now be approved by member states and entered into the Official Journal of the European reunion. It is expected that those steps will be completed by the original application date of May 26th, 2020.
The Parliament notes that the postponement only applies to the MDR and does not have any impact on the application of the In Vitro Diagnostic Regulation, which is still set to take effect on 26 May 2022.
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.
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
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.