Fresh Notified Body Scandal Bolsters Arguments for EU Medical Device Regulatory Reforms
A recent investigation by British journalists has brought to light questionable practices by certain European Notified Bodies, prompting greater urgency for medical device regulatory framework revisions proposed in September 2012.
Three Notified Bodies in the Czech Republic and Slovakia responded to an application for a metal-on-metal hip implant device filed by The Daily Telegraph and the British Medicine Journal, offering consultation to obtain approval for the product. Similar devices have been withdrawn (with considerable publicity) over the past year in the US, EU and other markets due to significant safety issues.
The British investigators' findings prompted European medical device industry trade group Eucomed to reiterate its support for European Commission plans to improve the EU Notified Body system, as well as for Notified Body system reforms included in medical device directive revisions.
Although this new scandal comes at an awkward time for the European medical device sector and could bring about fresh scrutiny of the CE Marking process, the investigation also demonstrates the necessity of selecting a qualified and competent Notified Body for regulatory review in Europe.