Why Aesthetic Products Are Regulated Under MDR
Annex XVI products come under the scope of the MDR because like medical devices, many are implanted in or used on the human body and thereby present a comparable risk to medical devices. There was no other EU regulatory vehicle suitable for them.
As mentioned above, some products that now fall within the scope of Annex XVI to the MDR were already regulated as medical devices on the EU market under the MDD and currently benefit from transitional arrangements as legacy devices under Article 120(3) of the MDR. However, due to the delay in the adoption of the common specifications, manufacturers of these products might see their CE marking certificates of conformity under the MDD expire before they even have a chance to obtain new CE certificates of conformity under the MDR, which is only possible once the Common Specifications are adopted and applicable.
As a result, some products that have been on the EU market for some time may simply no longer be available, regardless of their safety records, along with those that, arguably, are in urgent need of regulation and close assessment, such is the indiscriminate impact of the delays.
Manufacturers of devices without an intended medical purpose (Annex XVI products) are considering potential action against the European Commission for failing to adequately prepare the necessary infrastructure for them to comply in time with the new Medical Device Regulation (MDR).
