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.
User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.
The acquisition adds to the company’s plastic surgery and regenerative medicine portfolio.