McGuinness appointed to negotiate medical devices regulation

The EU is set to update legislation on 'medical devices', everything from home-use items like sticking plasters, pregnancy tests and contact lenses to x-ray machines, pacemakers, breast implants and hip replacements. And Mairead McGuinness, Fine Gael MEP for Meath and Ireland East, has been appointed as lead negotiator on the proposed new regulation for the largest and most influential group in the European Parliament, the EPP (European People's Party). The aim of the new regulation is to ensure that these and others products are first of all safe, but also that they can be freely and fairly traded throughout the EU, according to the MEP. "Existing EU rules date back to the 1990s. They have not kept pace with the enormous technological and scientific progress of the past 20 years," Ms McGuinness stated. "Countries interpret and implement the current rules in different ways. That can leave consumers open to unsafe practices, whether such arise through honest mistakes or dishonourable intent. "For example, it is not always possible to trace medical devices back to their supplier, so new rules on traceability are needed," she said. Ms McGuinness said the need for greater transparency has been highlighted by recent scandals, including the PIP scandal which has resulted in women receiving breast implants made from materials which were not authorised for use. "While it has emerged that the PIP case arose from criminal activity, it served to show some of the weaknesses in the regulation of medical devices. "There have also been problems with some metal-on-metal hip replacements which affected patients who in some cases needed to have hips removed and replaced. "While it is impossible to give 100pc guarantees about new devices, we need to improve the level of checks and balances in the sector to give patients access to the latest medical devices to improve the quality of their lives and to give the industry the possibility to continue to innovate in the future. The rules must be strengthened, establishing in law obligatory sampling and testing of products and unannounced factory inspections." The MEP said that her work on the new regulation begins immediately and the target date for adoption is 2014 with the new rules gradually coming into effect from 2015 to 2019.