European Union Archives - Medical Design Sourcing

European IVDR application partially postponed

Ronald Boumans, Emergo by UL

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.

Get the full story here at the Emergo Group’s blog.

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The European Union has become a leading COVID-19 vaccine exporter

The European Union is now one of the largest exporters of COVID-19 vaccines globally, having provided 150 nations with more than one billion vaccine doses.

The U.S. has exported fewer than 200 million vaccine doses to date but has pledged to donate more than one billion.

China has pledged to donate two billion doses by the end of the year. As of September 23, the Chinese foreign ministry stated that China had exported 1.2 billion doses to more than 100 countries.

The EU announced in September that it would provide an additional 200 million doses to low-income countries in Africa and elsewhere.

“We know that other countries also have to step up,” EU Commission President Ursala von der Leyen told the AP. “That’s the only way to beat the pandemic.”

To date, 47.6% of the world’s population has received at least one dose of vaccine, according to Our World in Data. But most of those doses have gone to middle- and high-income nations. Less than 3.…

EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature.

Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

As a result of the approval, vials of the vaccine can be stored in all 27 European Union (EU) member states at the updated temperatures as an alternative to the ultra-low requirements, offering flexibility to distribution and inoculation, according to a news release.

“From the beginning our goal was to make our vaccine broadly available to people around the world. This approval…

EU secures four million additional doses of Pfizer-BioNTech vaccine

The European Commission has announced that it has secured four million more COVID-19 vaccine doses than it had expected to be delivered over the next two weeks.

The vaccines will help E.U. “tackle coronavirus hotspots,” “facilitate free border movement” and fight COVID-19 variants.

The E.U. has been involved in a recent vaccine-related tussle with the U.K., with European Council President Charles Michel accusing the U.K. of blocking vaccine exports to the Continent. U.K. Prime Minister Boris Johnson has refuted that claim.

The U.K. has outpaced the E.U. in vaccine administration, having administered vaccines to more than a third of its population while the E.U. has done so for 9.5%.

Several regions in Europe have seen infection rates and hospitalizations tick up recently, including Tyrol in Austria, Nice and Moselle in France, Bolzano in Italy and some parts of Bavaria and Saxony in Germany.