• Covid-19

McGuinness leads move to suspend medical device regulation changes

Mairead McGuinness
Fine Gael MEP Mairead McGuinness. Photo: Flickr Creative Commons License.

First Vice-President of the European Parliament and Fine Gael MEP Mairead McGuinness says it is time to “push the pause button” on new legislation related to medical devices as the world deals with the Covid-19 pandemic.

On Wednesday, the EU Commission agreed to temporarily suspend the introduction of new rules to regulate the medical devices industry. A formal vote on the matter will take place in April and it is expected the new measures, due to open into force in May, will be delayed until a time yet to be determined. It was deemed, by MEPs, that now was not the time to force extra restrictions and confusion upon manufacturers at a time when medical equipment is in high demand.

The Ardee woman, who represents the European Parliament Midlands North West in Brussels, wrote to political groupings this week and successfully gathered the support of the three largest political groupings to put the vote back.

McGuinness had led negotiations on the new regulation during its drafting and steered it through Parliament to this stage. EU Commission President Ursula von der Leyen and the Health Commissioner Stella Kyriakides were both contacted and they offered their support to the request for greater flexibility on the timing of the implementation of the new rules.

On Tuesday, trade group MedTech argued that implementation of the Medical Device Regulation should be delayed until six months after the COVID-19 crisis has passed.

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Speaking on Wednesday, McGuinness said, “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.

“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.

“I have worked with my 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,” she continued.

“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. I 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.”

Vice-President McGuinness – a perennial favourite of the bookmakers when it comes to betting markets for the next President of Ireland, for which she is priced at 9/2 – also paid tribute to medical professionals for their work during the Covid-19 pandemic.

“I 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,” she said.

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