Regulatory Focus™ > News Articles > MHRA Notes Surge in Device-Related Adverse Events During Past Year

MHRA Notes Surge in Device-Related Adverse Events During Past Year

Posted 16 July 2013 | By Alexander Gaffney, RAC

No, it wasn't your imagination - the UK's medical device sector really did have an abnormally high number of significant problems last year. That's one of the conclusions of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which just released a report regarding the state of the regulator for 2012 and 2013.

While the report contains a number of points purely of interest from an operational standpoint (MHRA is now using Accenture to "deliver a better risk-based inspection programme," for example), it also contains a plethora of regulatory factoids that cast light on the extent of some widely-publicized problems.

Chief among those problems have been deficiencies found in many medical devices, including breast and hip implants, the failures of which have spurred legislative proposals to shift the EU to a centralized premarket device authorization system similar in concept to that of the US.

While some in industry have maintained that the system remains robust, MHRA's own data shows a marked increase in the number of device-related adverse events discovered last year.

"Over the year the number of adverse incidents involving medical devices rose 26% while the Agency was dealing with the several high-profile public health issues arising out of the PIP breast implant scandal and accumulating evidence around the performance of metal-on-metal hip implants," it wrote in the report. "This took place against a backdrop of consultation and negotiations on the revision of European medical devices legislation," it added.

Kent Woods, outgoing chief executive of MHRA, wrote that in both the case of defective metal-on-metal hip implants and breast implants, the agency had "worked closely with national experts and with the professional associations to communicate information and guidance to clinicians and users as investigations took place."

Both incidents, he added, will "inform the current negotiation of the revision of the EU Medical Devices Directives."

MHRA's Report

Tags: UK, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.