The European Commission (EC) published a public letter to the PIP Implants World Victims Association and rejected the petition to claim the financial compensation at the European level.
The EC rejected the petition by invoking the responsibility of the national competent authorities/courts, while also enlisting many actions it has taken in order to avoid any further frauds to compromise the safety of medical devices:
”…the Commission’s services looked at the time of the incident for shortcomings of the legislation. The conclusions reached were incorporated in proposals for the revision of the medical devices legislative framework put forward to the legislators by the European Commission. Those findings, however, did not suggest that the EU system for regulating medical devices was fundamentally unsound.”
‘The new Regulations contain a series of important improvements aimed at modernising the current system,… One notable aspect is the obligation for manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability”.