Medical Devices Regulation breakthrough - crucial for patients and industry

Lead negotiator on the Medical Devices Regulation for the EPP Group and Vice-President of the European Parliament, Mairead McGuinness MEP, has confirmed that negotiations on a new Medical Devices Regulation successfully concluded this evening ((Wednesday).

The Medical Devices industry is a crucial one for Ireland and for Europe, according to MEP McGuinness: "In Ireland alone, there are 250 medical technology companies exporting €7.9 billion worth of products annually and employing 25,000 people - the highest number of people working in the industry in any country in Europe, per head of population."

"But more importantly, the industry is important for public health and wellbeing as it produces and continues to innovate new products and devices which help patients of all ages lead healthier and better quality lives. The aim of the new legislation is to ensure enhanced patient safety and to facilitate innovation."

McGuinness welcomed the agreement, reached after a tough, lengthy process which began in 2012 when the Commission presented the proposal following concerns about aspects of the existing laws.

The decision to move from a Directive to a Regulation was taken to ensure common application of the law across member states and avoid differing interpretations between member states. A number of health scares including the PIP breast implants scandal and problems identified in replacement hips required a response from the EU. A need for enhanced scrutiny pre and post market was clearly identified and is provided for in the new regulation. Criminal activity in the French company Poly Implant Prosthèse (PIP) affected thousands of women in Ireland and across the EU.

During the negotiation, patient safety took precedence, with a particular focus on high risk devices in pre-market phase and to ensure that post-market surveillance and the reporting of problems is enhanced.

"Ensuring that Europe’s MedTech industry can continue to innovate and develop medical devices that save and improve people’s lives is also an important priority,” McGuinness said in Brussels, following the conclusion of the negotiations between the European Parliament, Council and Commission.

"The ultimate aim of the new Regulation is to protect public health, ensuring medical devices placed on the European market are safe and of benefit to patients and to improve patient access to new innovative diagnostic and treatment options in a timely fashion. The legislation covers everything from sticking plasters to contact lenses, x-ray machines, pacemakers, hip prosthesis and more. It will replace existing rules that date back to the 1990s.

“Manufacturers will have to comply with stricter rules, requiring manufacturing plants to be subject to unannounced inspections at least every five years. The more high risk, Implantable devices such as hips and pacemakers will be subject to an extra layer of scrutiny which will be carried out by a panel of experts.

“Medical devices will also be assigned a unique identifier number to improve traceability. Implant cards, the size of a credit card, will also enhance traceability providing the relevant information and device model for devices, for example a knee replacement,” McGuinness added.

MEPs and Health Ministers from the 28 Member States will vote on the new Medical Devices Regulation in the coming months.