Vital to allow the industry deal with the unprecedented demand

The EU Commission has today agreed to temporarily suspend the introduction of new Medical Device rules amid the Covid-19 crisis “With all our systems under enormous pressure, especially our medical devices industry, it is time to press the pause button on implementation of the Medical Devices Regulation, due to come into force in two months, until such time as things return to normal said Mairead McGuinness MEP and Vice President of the Parliament "It's the right move. I will do my utmost to ensure that the European Parliament adopts the proposal as soon as possible. We must now ensure that all those who can manufacture ventilators, masks, tests and other medical devices do so and focus on addressing the current crisis", said EPP MEP Peter Liese, health spokesperson of the largest group in the European Parliament (EPP- Christian Democrats) and supported the announcement of the European Commission to postpone the implementation of the new medical devices regulation for one year.

“The updating of the rules for medical devices was due to be implemented in full this year, but this is not possible given the focusing of scarce resources on providing essential personal protective equipment (PPE) and medical devices to the healthcare sector across the EU. “We have worked with our MEP colleagues, across the EU Parliament and we are of one voice in requesting the suspension of the introduction of new rules to give time and space to the sector at this very busy time”, said Mairead McGuinness MEP & Peter Liese MEP, confirming the agreement on the postponement today (Wednesday). The proposal to press pause has the support of the three largest political groupings in the Parliament and will now be formally voted upon in April. McGuinness and Liese have led negotiations on the new Regulation during its drafting and steered it through Parliament. The MEPs wrote to the EU Commission President, Ursula von der Leyen and the Health Commissioner, Stella Kyriakides, requesting greater flexibility on the timing of the implementation of the new rules. Today, the Commission confirmed its support for the suspension. “With the healthcare industry rightly diverting resources and attention to respond to COVID-19, now is not the time to change the rules. In order to maintain a steady supply of medical equipment, we should not overly burden the industry with changes”, McGuinness & Liese said. “Having worked on the Medical Device legislation through the Parliamentary process, we understand how important the new rules are in terms of improving patient safety and industry innovation so the new rules will not and should not be postponed indefinitely. However, given the current unforeseen circumstances, it is reasonable to postpone its introduction temporarily until the situation normalises. “We want to take this opportunity to thank all the doctors, nurses, paramedics and indeed all hospital staff on the frontline fighting COVID-19 as well as those manufacturing medical equipment for they also have a role in saving lives”, the MEPs concluded.

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