MDR reportedly causing medtech companies to leave EU market

The EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters.

Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying with the MDR were simply too much.

The EU’s MDR went into effect in 2021. Medical device makers have had until 2024 to transition previously certified devices to the new standard.

Reuters reports that European doctors’ groups are already reporting medical equipment shortages. The Russia-Ukraine war has caused material shortages that have further exacerbated the problem.

EU leaders have become aware of the problems. The EU Health Commissioner Stella Kyriakides has proposed extending the transition deadline to 2027 for high-risk devices — 2028 for medium- and low-risk produ…

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

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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.

Get the full story at our sister site, Pharmaceutical Processing World.

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EU allows remote audits for medical devices during pandemic

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively.

In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic has made in-person audits at manufacturers’ facilities difficult if not impossible.

Get the full story on our sister site, Medical Design & Outsourcing.

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