Concerns Raised Over Medical Device Regulation

Expert Calls For Reaction From Authorities Over Guidelines


Product liability lawyers at Irwin Mitchell have called on medical device regulators to respond to concerns raised about guidelines put in place to protect patients.

A report in the British Medical Journal has revealed that manufacturers and doctors have suggested that legislation in place to regulate medical devices is both cumbersome and inadequate for patient safety.

That article also raises concerns over conflicts of interest, when doctors are involved in trials of devices that they have had a hand in designing/producing.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has welcomed the calls, stating that any debate on this issue will help improve understanding of the regulations in place on my products.

Irwin Mitchell’s specialist Product Liability team represent patients who have suffered injury or illness as a result of problems with medical devices, including those who have endured pain or disability after being fitted with De Puy hip replacement implants.

Gary Walker, a solicitor at Irwin Mitchell, said:  “Recent concerns raised over medical products have put the issue of regulation firmly in the spotlight, so it is vital that all agencies take this opportunity to engage in debate related to how people can be protected from the risks of faulty devices.

“It is also vital that the MHRA responds to these concerns in the right manner, ensuring lessons can be learned from the past which will keep more people protected in the future.”

Our specialist medical negligence solicitors will provide you with free initial advice on your compensation claim if you have suffered as the result of a defective or faulty medical products or medicines. View our Defective Medical Products Drugs Or Medicines Claims page for more information.