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Labour MEPs have warned the government that any repeal of new EU laws on medical devices could harm patient safety and risk a repeat of the hip replacement and PIP breast implant scandals.

The new law, which the European Parliament voted for today, will strengthen requirements for medical devices and require high-risk devices to undergo additional, pre-market assessment. Stricter rules on post-market surveillance will also ensure a faster response if there is a problem with a device and a new id system will improve traceability.

MEPs also backed new laws to ensure in vitro diagnostic medical devices – such as pregnancy tests and blood tests – are accurate and reliable.

Dame Glenis Willmott MEP, the parliament’s lead negotiator on a new Medical Devices Regulation, and Labour’s European spokesperson on health, said:

“It would be unacceptable if Brexit meant patients in the UK got less protection than those in the rest of the EU, or waited longer for access to new medical devices. The government must maintain these new laws after the UK leaves the European Union.

“Not only would patient safety be at risk, but the medical devices industry - an important sector in the UK - and manufacturers based in Britain will still have to comply with these requirements in order to market their products in the EU, so it would make no sense for the government to repeal these laws and require them to apply for authorisation twice.

“There is also no guarantee the UK will still have access to the EU-wide database for sharing information on medical devices after Brexit. The government must ensure continued close cooperation with the EU on monitoring medical device safety.”

Dame Glenis added:

“We all remember the scandals with metal-on-metal hip replacements and PIP breast implants, which highlighted the weaknesses in the previous legislation. Some patients still don’t know if they have PIP implants.

“The new law will make the rules for medical devices much stricter and will ensure all devices are checked thoroughly before authorisation and carefully monitored after being placed on the market, so if a problem does arise, it will be picked up quickly.

“Devices will be fully traceable with the introduction of a Unique Device Identification number, so in the future we will know which device has been implanted into which patient.  Authorisation requirements will be even stricter for the highest risk medical devices, like implants, insulin pumps and pacemakers, which will have to undergo an additional assessment by an expert panel before they can be authorised. And the new standards on in vitro medical devices will increase their accuracy and reliability.

“Patients rightly expect that if a medical device is available on the market then it is safe, but unfortunately this hasn’t always been the case. We have a responsibility to make sure patients have confidence in medical devices.”

Wednesday, April 5, 2017

Any repeal of new EU laws on medical devices risks patient safety, warn Labour MEPs

Labour MEPs have warned the government that any repeal of new EU laws on medical devices could harm patient safety and risk a repeat of the hip replacement and PIP...

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Labour MEPs have called on the government to urgently come up with a plan that will speed up the rebuilding of communities hit by the 2015 floods, after the European Parliament voted today to approve the release of more than £50 million of EU funds to provide assistance to affected areas.

The funds can be used for the restoration to working order of infrastructure for energy, water, transport, telecoms, health and education; temporary accommodation and emergency services to meet the immediate needs of the population; securing of preventive infrastructure such as dams and dykes; measures to protect cultural heritage; and clean-up operations.

In total, £51 million will be given to the UK government at the beginning of May, money that must be spent in the regions affected. It is for the government to decide whether to spend the money directly or to allocate it to local councils to spend.

Julie Ward MEP, Labour MEP for North-West England, said:

“In my constituency, thousands and thousands of people were affected by the floods, which left a trail of destruction and devastation: £2.1 billion of damage, more than 16,000 households flooded - around 3,600 households placed into alternative accommodation - nearly 5,000 businesses flooded.

“The money should be spent on improved flood defences, which failed catastrophically, but most importantly, the money must go to the people who suffered the consequences, many of whom are still living in temporary accommodation.

“The government fiddled while Cumbria flooded, but now, thanks to the European Union Solidarity Fund, we can speed up the recovery. Tory government ministers waited forever to apply for the funding. They must not continue to dither and delay - we need a plan to rebuild the region, and we need one now.”

Clare Moody MEP, Labour’s European Parliament spokesperson on budgets, added:

“It’s great news that these funds are available for those affected by the floods, but we cannot have it now lying dormant in a bank account in Whitehall - knowing this money was coming, the government should already have a plan to spend the £50 million urgently and prudently.

“Having taken their time to apply for assistance - and only applying after the Commission reminded them of the deadline - it is their responsibility to be quicker with the implementation.”

Wednesday, April 5, 2017

Labour MEPs: Tories must ensure £50m of EU money is made available to flood victims

Labour MEPs have called on the government to urgently come up with a plan that will speed up the rebuilding of communities hit by the 2015 floods, after the European...

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Labour MEPs have warned everyone involved in the Brexit negotiations to tone down the political grandstanding and start the serious business of negotiating, as the European Parliament today set out its response to the triggering of Article 50.

Dame Glenis Willmott MEP, Labour’s Leader in the European Parliament, said:

“It won’t always be easy to take the responsible path in the coming months, but it is what we must do. There are some in the European Parliament, and beyond, who are actively hoping to plunge Europe and Britain into chaos, through a disorderly, no-deal Brexit. Why? Because they have no answers to the questions that constructive negotiations will bring.

“Article 50 has been triggered, and those Leave campaigners who now sit in the cabinet or in parliament must take responsibility for the promises they made. A majority voted for Brexit in the referendum, but not to lose their jobs or make themselves poorer - and certainly not to see public services like the NHS suffer.

“These serious times call for a serious response - the Brexit talks are too important to be dealt with as a political game. It is time to stop grandstanding and start the serious business of negotiating. And in order to get a constructive deal, we will need a more measured tone from the government than we have seen from ministers in recent months.”

Wednesday, April 5, 2017

Labour MEPs: Time to stop grandstanding and start serious business of negotiating

Labour MEPs have warned everyone involved in the Brexit negotiations to tone down the political grandstanding and start the serious business of negotiating, as the European Parliament today set out...

Read more

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