EU intends to postpone medical devices regulation by one year

The new regulation on medical devices was supposed to come into force on 26.05.2020 this year. Among other things, it provides uniform and more stringent criteria for so-called notified bodies when approving medical devices and establishes the procedure for approving clinical trials of medical devices.
EU Health Commissioner Stella Kyriakides said: “We must not lose a second in our fight against the coronavirus. With the measures taken, safe and vital medical devices and protective equipment such as masks and surgical gowns can reach the EU market much faster”.
“That’s the right move. I will do my utmost to ensure that the European Parliament adopts the proposal as soon as possible,” he said. “We must now ensure that everyone who can do it manufactures ventilators, masks, tests and other medical devices and is not prevented from doing so.”
In the corona crisis it is necessary to improvise, says Liese. “If, for example, a part is not available, you have to work with a replacement and this has to be done immediately and not after months of testing”.
In addition, companies that had previously done something different would now also be involved in the production of the necessary equipment. “Here, it must be possible to check the most important things very quickly and unbureaucratically and then start production,” says Liese.
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© fos/, 25.03.2020
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