| Diapharm GmbH & Co. KG
Dermal fillers: collagen and hyaluronic acid injectables are now class III medical devices
The new Medical Device Regulation (MDR) will have a major impact on manufacturers of injectable soft tissue fillers, or dermal fillers, containing hyaluronic acid, collagen or other related substances. Products without a medical purpose will be subject to the MDR in future just like medical devices. This means that dermal fillers are to be classified as class III, the highest risk class, if their ingredients are absorbed – as is the case with hyaluronic acid and collagen. The products must be CE certified by a notified body to allow them to continue being marketed after 26 May 2020. To do so, manufacturers will require documentation including clinical evaluation in accordance with MEDDEV as well as an appropriate quality management system. Dermal fillers will also need to fulfil common specifications that are currently being developed by the EU Commission. The complexity of the processes could lead to bottlenecks and marketing stops. Time is running out!