• 26-SEP-2013

  • SOURCE: S&D Group at European Parliament

Europe Fight for Better Patient Safety on Medical Devices

Breast and hip implants, surgical instruments and pregnancy tests should be monitored much more efficiently in the future in the European Union. A series of scandals in the recent past has put the spotlight on the weaknesses of the approval system for medical devices and patients were right to be concerned.

Today however, the environment and health committee of the European Parliament voted in favour of increased patient safety. The new regulation will ensure a state-of-the-art assessment procedure for medical devices in Europe.

The Parliament's rapporteur, S&D MEP Dagmar Roth-Behrendt, said:

"We have achieved our main objective today: patients will be better protected from defective products and a more efficient system to grant market access to new devices will be soon in place.

"However, I would have liked a more ambitious result. 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 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 made sense as in future we will see many devices incorporating or administering medicines. However, due to aggressive and uninformed lobbying from the industry we would not have gained it.

"Our 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. Also, clinical investigations on patients will be more systematic and patient safety will benefit.

"We have also reinforced the controls on the 80 so-called 'notified bodies', which are responsible for assessing the performance and safety of medical devices. We want the best supervising bodies in Europe. The qualification requirements for the staff of notified bodies will therefore be reinforced and requirements for transparency in their work will be increased.

"Clarification of the rules under which a device can be reprocessed is another major improvement introduced by the S&D Group. From now on, it will be prohibited to reprocess a device labelled as single-use. The highest and most coherent standards will be put in place for reprocessing reusable devices in order to make sure patients will no longer be treated as guinea pigs.

"Overall, this is a good compromise and patients can be reassured that safety in Europe has been the central focus during our work in recent months."