Market voices concern over CE marking shake-up following PIP scandal
Medical device experts fear a potential reform of the regulatory system following the recent PIP breast implant scandal could cause the industry to grind to a halt and prevent the development of innovative technologies.
Over recent weeks, there have been increasing calls for the CE marking process that approves all medical devices for use across Europe to be tightened up, and in particular the 70 privately-run ‘notified bodies’ that hand out certificates to be more closely monitored.
The pressure follows the recent PIP breast implant case, in which a CE Mark-approved company was found to be using industrial-grade silicon in its products which had not been passed for use in humans.
You can tighten up the regulations so much that the whole industry grinds to a halt. It would take so many years to get things to market, and costs would be so high, that it would put people off
However, the supply sector is concerned that any changes to the current system could prove an obstacle to continued innovation.
Speaking to BBH this week, Jerry Turner, chief executive of Cambridge-based MedTech consultancy, Team Consulting, said: “It is a difficult situation. We don’t want to get to a point like they had in the United States with the early FDA process, where the approach for every approval is that you are guilty until proven innocent.
“You can tighten up the regulations so much that the whole industry grinds to a halt. It would take so many years to get things to market, and costs would be so high, that it would put people off. Over-regulation would be harmful and I am concerned they might go too far.”
The Medicines and Healthcare products Regulatory Agency (MHRA), which co-ordinates the CE marking process in the UK, is supportive of system reform, and, as reported by BBH last week, EU health and consumer affairs chief, John Dalli, has also demanded improvements.
Our experience is that suppliers and manufacturers in the medical devices marketplace are interested in helping people. We do not often see people trying to circumvent the regulations
But Turner is warning that a major reform would not necessarily prevent a repeat of the PIP incident.
He said: “Our experience is that suppliers and manufacturers in the medical devices marketplace are interested in helping people. We do not often see people trying to circumvent the regulations.
“The issue with the PIP breast implants is not, according to the MHRA, to do with the rate of rupture, which is apparently in line with the failure rate of other leading implants. The issue is that the manufacturer apparently used an unapproved silicone, which was brought to the regulator’s attention during the saga. This is not a widespread problem from what we see. All of our clients follow regulatory guidelines carefully. They want commercially-successful drugs and devices and they do this by playing by the regulatory rules and enhancing, and saving, the lives of patients.
It is not in the interests of companies with integrity to try and trick the regulators or bypass the process
“It is not in the interests of companies with integrity to try and trick the regulators or bypass the process. They do get found out and they suffer the legal and financial consequences.
“The regulator can only do so much, but if someone is intent on breaking the rules, they will not necessarily know. It is very difficult to see how any change to the process could make this any easier to pick up.”