Changes to European medical device regulations will not protect patients with diabetes, according to the European Association for the Study of Diabetes (EASD).
The criticism comes after the European Commission voted to approve new proposals to draft legislation to tighten medical device regulations and improve patient safety.
EASD President Professor Andrew Boulton said: “These changes will do little to improve Europe’s antiquated regulations for regulating devices that were brought in for electric toothbrushes and stethoscopes — not the wide range of medical devices vital for diabetes patients today.
“We are talking here about devices that people depend on for their lives, such as insulin pumps and technology that monitors blood glucose.”
Professor Boulton made the comments during the annual meeting of EASD in Barcelona. “Just as with drugs, devices can provide major benefits to patients but can also cause major harm when things go wrong,” he said.
Along with the European Society of Cardiology (ESC), EASD is calling for the European Commission to create a central European Device Agency (EDA), just as already exists for drugs (the European Medicines Agency/EMA). He was joined at the meeting by other experts in this field including Dr Deborah Cohen, Investigations Editor at the UK-based British Medical Journal. Professor Boulton applauded Dr Cohen’s reports and undercover work that have ruthlessly exposed Europe’s sub-standard system for regulating medical devices.
The system for approving medical devices in Europe is far less rigorous than that required for approving new drugs, and is also less stringent than the system used to approve devices in the US.