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