SOURCE: S&D Group at European Parliament
Safer Medical Devices: Right-Wing Gave Way to Lobbyists
The Socialists and Democrats in the European Parliament welcomed the new legislation because it will ensure a state-of-the-art assessment procedure for medical devices. However, in order to achieve a compromise with the right-wing majority in the Parliament the S&D Group had to drop its request – supported by doctors and patients – for a central system of pre-marketing authorisation.
The Parliament's rapporteur, S&D MEP Dagmar Roth-Behrendt, said: "We have partly achieved our main objectives today: to better protect patients from defective products and create a more efficient system for granting market access for new devices.
"This is a step in the right direction, but unfortunately it is not a milestone. My initial intention was to establish a system of pre-marketing authorisation for high-risk products such as heart valves, breast implants or pacemakers to ensure that only safe products will be used in or on patients. This system would have given a stronger role to the European agency for public health, the European Medicines Agency (EMA) which would have made sense as in future we will see many devices incorporating or administering medicines. However, due to aggressive and uninformed lobbying from the industry it was not possible to achieve this.
"The new system will however enable the best medical specialists in Europe to re-examine some devices where new technology is involved or in cases where many incidents have occurred in the past. However, the medical specialists' opinions on the results of the clinical tests performed by manufacturers will not be binding for member states.
"More importantly, only implantable devices in the high-risk 'class III' can be assessed, and unfortunately not all products will fall into this category. Also, the methodology for these tests on patients ('clinical investigations') will not be as transparent as expected. Patient safety could have been much better protected. This is a real pity!
"Controls on the 80 so-called 'notified bodies', which are responsible for assessing the performance and safety of medical devices, will be reinforced. A category of special notified bodies designated by the European Medicines Agency has now been created. There will be higher qualification requirements for the staff working for all notified bodies because we want the best experts to look at devices before they are used on or in patients in Europe.
"The S&D Group also managed to pass a new clarification of the rules which allow devices to be reprocessed. The aim is to respect the label 'single-use' and avoid any reprocessing of such products. We will put in place the highest and most coherent standards for reprocessing reusable devices in order to make sure patients will no longer be treated as guinea pigs.
"Overall, this is an acceptable compromise and patients can be reassured that safety in Europe has been the central focus throughout our work in recent months."
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* Following the co-decision procedure, the Parliament will start negotiations with the Council by the end of the year.