Pan-European medical technology trade association Eucomed has issued a statement expressing “great concern” that Poly Implant Prothèse (Pip) may have violated regulations by using industrial-grade silicone in breast implants and allegedly falsifying or withholding documents. In the press release, Eucomed strongly condemns Pip’s behaviour and breach of trust, if the allegations are confirmed, and goes on to say that it recognises the need to “modernise and strengthen the current medical devices legislation in Europe.”
Stressing that the current regulatory system has been remarkably effective in bringing products to market rapidly without compromising safety, Eucomed reiterates its call for a legal framework that establishes a consistent EU-wide regulatory approach. The six steps to a “smarter legal framework for medical devices” is summarised by Eucomed as follows:
1. only the best Notified Bodies;
2. one approach to vigilance and market surveillance;
3. strengthened harmonised standards;
4. consistent implementation of guidelines;
5. increased transparency;
6. an integrated approach: better coordination and management.
It’s Quixotic to expect a system to deliver absolute protection against fraud or deliberate abuse, as appears to be the case in l’affaire Pip, but public safety and confidence and ethical behaviour must be the foremost priorities of any organisation active in the healthcare sector, stresses Eucomed.
French medtech association Snitem addressed the scandal in a press release issued on 6 January, as reported in medtechinsider (Pip Is Exception, Stresses French Medtech Association).Norbert Sparrow