Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.
Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.