“It’s important that we are honest with each other and assess the state of readiness,” he told his EU counterparts. The new rules further require notified bodies to obtain new accreditation and authorization to enforce MDR. On April 3, 2020, the EU Commission published a communication in its virtual press room stating that, due to the coronavirus pandemic, it is proposing to postpone the date of application of the European Medical Device Regulation 2017/745 by one year to May 26, 2021. Devices in full compliance with the current Medical Device Directive (MDD) that are either (1) reusable surgical instruments, (2) in sterile conditions, or (3) have a measuring function, may remain or be placed on the market until May 26, 2024. To implement the new rules, both the industry and relevant authorities must prepare and generally implement changes that are costly and time consuming.The Commission’s intention to propose a postponement of the MDR application date is a reaction to the ongoing worldwide coronavirus crisis that also affects the medical device and technology industry. Get our stories by email.Do you believe journalism can make a difference? A following press release from the Commission states that the Commission is working on submitting the proposal in early April to ensure time for the European Parliament and Council to adopt it. For just $15/month you can help expose the truth and hold the powerful to account. He estimated that 20 notified bodies would be authorized to process medical device licenses — known as “Andriukaitis was speaking on behalf of his colleague EU industry commissioner Elżbieta Bieńkowska, who has chief responsibility for medical device regulation. Conditions and timelines for such implementation were decided by the European Parliament and [member states] based on thorough analyses and discussions.”Concerns raised by European health ministers comes after months of lobbying pressure from the medical device industry, including notified body companies, warning of a lack of readiness. But many health ministers now believe that Europe’s complex, part-privatized regulatory regime — which they were unwilling to scrap — has failed to prepare itself for the new set of rules.“We don’t want bottlenecks in the provision of [medical] devices for patients in May,” Germany’s Jens Spahn told a He called for an existing grandfathering clause in the legislation — which effectively allows many existing medical devices to stay outside the new rules until 2024 — to be expanded to other products and extended to an even later expiry date.Spahn pointed out that only two private certification firms, known as “notified bodies,” had been cleared to process medical device safety licenses within the European Union (EU). It is the intention that the forthcoming proposal will ease the pressure on national authorities and the industry, allowing them to focus on the urgent priorities related to the crisis.The intent to propose a postponement of the MDR application date follows a series of call outs from the industry.
If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply. If you would like to learn how Lexology can drive your content marketing strategy forward, please email "As Company Secretary, I find these articles very useful and appropriate and also share them with the lawyers and paralegals in the department". You may also like: Shaping the Human Side of Medical Devices in Critical Care: The Implication of Human Factor Studies Published a new section following European Parliament and Council decision to delay the full implementation of the Medical Device Regulation by one year to 26 May 2021. The European Commission has postponed by one year the date of application of the Medical Devices Regulation (MDR) till 26 May, 2021, “to allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.”. Both nations have large numbers of workers employed in the device industry and are The largest pan-European industry trade group, MedTech Europe It blames the failure to prepare on the commission, which, it says, has not set out necessary regulatory guidelines and infrastructure in time.
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