Newsletter No 13 April 2020
Subject: MDR postponed until May 2021
European Commission spokesman Stefan De Keersmaecker announced on the 25th of March 2020 a possible delay of the introduction of the MDR:
“With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.”
The European Parliament on Friday, 17th of April 2020 voted decisively in favor of a proposal to delay by one year the implementation of the EU’s Medical Device Regulation. Friday’s approval — with 693 votes in favor, 1 against, and 2 abstentions — clears a key barrier to the enactment of the delay, but the proposal now has to be approved by the member states and published in the Official Journal before taking effect. According to Parliament, those actions are expected at the latest by May 26, MDR’s original enforcement date.
The Parliament’s decision was based on wanting to prevent device shortages and delays in getting products on the market against constraints posed by the pandemic.
The body said in a press release following the vote that a delay would “allow authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic by continuing under current procedures.”
What does postpone the MDR mean for manufacturers, Notified Bodies and patients, and the MD industry?
Speaking generally the MDR is primarily meant to enable safer Medical devices on the market with improved transparency regarding post-market surveillance. On the other side of the medallion, it was also expected to bring higher costs during development and more stringent regulations that severely delay the time to commercialization.
Medical Device manufacturers throughout the EU were already facing plenty of challenges posed by the new MDR and many companies had already stated they are insufficiently prepared and feel the stringent timelines were unrealistic. In particular, the smaller companies could be forced out of a job because they are unable to comply with the MDR by the current date of application (26 May 2020), whether it is because of lacking resources or not being able to make the timelines.
Shortly, for manufacturers it would reduce the workload during the coronavirus crisis
The current demand for healthcare equipment (e.g. mouth guards, diagnostics, and breathing machines (and so on)) caused by the COVID-19 crisis is obliging Medical Device companies to work around the clock to supply their clients around the world. Taking this into account, it shouldn’t come as a surprise that additional tasks to comply with the new Medical Device Regulation might lead to a lack of focus on making sure that patients have access to the devices, they need to stay healthy.
Besides, many of the Medical Device companies have already had to make difficult strategic decisions to prioritize certain products (most likely products that generate the greatest sales to cover the costs of increased compliance requirements that are inherent to the new MDR). These products are usually chosen over other, less economically viable products that might very well be improving the quality of life for some patients, nonetheless. Perhaps the extra time will mean that companies have the extended possibility to get all their products certified under the new MDR or perhaps new products will be developed to take their place. in any case, both scenarios would lead to a larger spectrum of Medical Devices that are available to patients.
For Notified Bodies
Because all notified bodies needed to be re-accredited, which means performing joint assessments for initial designation, extensions and scope-expansions, the entire process was estimated to be completed in approximately 18 months. Optimistically speaking, manufacturers would not have known until into 2019 if their current Notified Body would still be accountable for their companies’ products.
There were already doubts about the ‘readiness’ of European authorities that are supposed to be the framework behind the MDR but last January 2020, only nine Notified Bodies had actually received their required accreditation. And as an interesting side-note it should be mentioned that out of the + – sixty Notified Bodies in Europe, not even half of them were pursuing re-accreditation. So, additionally, the total amount of notified bodies is suspected to be reduced in the future together with their respective scope on devices within the industry.
What does it mean practically for STS Medical Group?
STS will continue to maintain its focus on meeting the initial MDR deadline for Class I products, the postponement for our Group means we have more practical time to improve and review all our technical files to ensure a better and to focus on building an even more transparent approach.
This newsletter continues to be part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We will continue in our commitment and continue to provide you with the latest on the MDR journey, accompany also during the extended period of postponement. We are confident we will be able to continue to supply health care competently on customized surgical procedure sets and small kits.
The next MDR Newsletter will be issued in May
You want to know more about specific topics? Do you have any questions or comments? Write us!
CEO STS Medical Group
Dr. Sönke Asmussen
Group Manager for
Quality System Compliance