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Formal reassurance for industry that MDR will not take force in two months as originally planned appears to be on the horizon.
Despite regulators hardly budging the past year as industry worried a notified body shortage would render MDR implementation in 2020 unrealistic, a one-year postponement would recognize the burden medtechs face in trying to supply healthcare workers with necessary medical technologies to fight COVID-19 and maintain business operations while countries are shut down.
The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the rest of the world.
“Although the regulation contains very important elements to improve patient safety, in these unprecedented times, the priority should be on meeting the demand for medical devices and equipment,” Croatian Parliament member and S&D medical devices spokesperson Biljana Borzan said in a statement Tuesday.
“This should be seen as just a temporary measure. An extraordinary measure for extraordinary times. Therefore, we demand the Commission to postpone its implementation until after the fight against Coronavirus has been won.”
In a letter Tuesday to EC President Ursula von der Leyen and Commissioner for Health and Food Safety Stella Kyriakides, the group of S&D members of Parliament said they are also open to proposals by the Commission to make changes to the current directives.
Kyriakides flagged the Commission’s response on social media Wednesday.
MedTech Europe said Wednesday that while it welcomes the EC’s plans, as well as “the support that the European Parliament has expressed for this,” the trade association remains convinced “a similar solution is needed” regarding implementation of the In Vitro Diagnostic Regulation (IVDR).
The group argued that although IVDR’s start date isn’t until 2022, diagnostic makers’ preparations that would have happened this year is being equally disrupted by coronavirus response.
“Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution,” MedTech Europe wrote in a statement Wednesday. “By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID19 pandemic.”
MedTech Europe had on Monday requested that implementation of both MDR and IVDR be paused and not resumed until six months after the crisis passes, which the group said could be defined by the World Health Organization declaring the pandemic over.
By: Maria Rachal
Source: Medtechdive
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy. The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older.
Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm could create a new closed-loop system for largely hands-off diabetes management.
Apnimed started the year by bagging nearly $80 million in extended series C funds and the momentum has kept up, with the sleep-apnea-focused biotech nailing its goals in a phase 2 study. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day.”
