Crimson Life Sciences, a division of TransPerfect Translations International , has announced new services to assist US medical device manufactures planning to respond to the French Decree No 2012-743 of 9 May 2012.
The decree, proposed and based on the recent PIP breast implant scandal, makes healthcare professionals prohibit direct-to-consumer (DTC) advertising and submit specific statements on marketing material such as packaging and labels.
It also suggests manufacturers provide information regarding device class, reimbursement and a new internal reference number issued by the ANSM, the French equivalent of FDA.
In case of violation, the decree levies stiff financial penalties, up to $125,000 for each infraction, according to the European Union (EU).
EU health and consumer policy commissioner John Dalli said: "Everybody was shocked by the scandal involving fraudulent breast implants, which affected tens of thousands of women in Europe and around the world."
In response to the increased regulatory scrutiny, the company has increased and trained resources to help manufacturers prepare the required documentation changes.
Crimson Life Sciences president Marc Miller said a number of the company’s clients were taking emergency measures to prepare advertising with the appropriate verbiage for approval, but there will be a significant backlog as the deadline approaches.
"The new reference number requirement could be especially problematic," Miller added. "Prior authorisation by the ANSM includes review of a hefty product file for each individual advertisement and can take up to two months."