We knew that the Poly Implant Prothèse (Pip) breast implant scandal would affect device regulations, but there was uncertainty about its scope. The so-called Pip resolution, drafted by the Environment and Public Health (ENVI) Committee of the European Parliament and passed unanimously at the end of April, may shed some light on that.
The resolution calls for improved oversight of Notified Bodies, stricter vigilance reporting, more unannounced audits of manufacturers and the establishment of networked implant registers. All well and good, and pan-European trade association Eucomed by and large applauded the recommendations. ENVI did not stop there, however.
The recent breast and hip implant fiascos denote “a failure of the current system of certification of compliance,” writes the committee, which asks the European Commission “to shift to a premarket authorisation system for certain medical devices.” That did not sit well with Eucomed, which pointed out that Europe already has a de facto approval system for implantable and Class III devices. Given the tenor of the document, Eucomed also felt the need to explain, yet again, why drugs and devices are fundamentally different and cannot be regulated in the same manner.
Randomised control trials are relatively straightforward to perform for pharmaecuticals, and efficacy and relative safety can be statistically demonstrated, notes Eucomed. Not so for medical devices: it is difficult to implant a placebo hip, for example.
It is also worth pointing out that device impact depends on clinician training and experience, patient selection and the healthcare setting. This varies by doctor, hospital and country and is thus nearly impossible to predict with any precision, adds Eucomed.
Where does that leave us? In a precarious position? Maybe not, suggests Erik Vollebregt, a Dutch lawyer specialising in medical device issues.
Parliament is sending a clear shot across the bow to the Commission, writes Vollebregt on his medicaldeviceslegal.com blog. The resolution is an indication of what Parliament wants to see in the revision of the medical device directives. “Parliament can make life difficult for the Commission by killing the proposal or crippling it with amendments,” he writes. Ultimately though, adds Vollebregt, the Commission is unlikely to want to set up a premarket approval system—if only for budgetary reasons—and will look for other ways to appease Parliament. Let’s hope he’s right.