The EU’s MDR means big changes for devices with non-medical purposes.
Find the list of questions consolidated from the "EU Medical Device Regulation and its implications for cosmetic devices" webinar below:
How would you classify Annex XVI group 5 products?
This group is constituted by active devices therefore wit is possible to classified them based on rules 9 to 13. It is very important to determine the degree of the eventual risks derived by the exchange of energy.
When is it required to perform a formal clinical investigation?
Clinical investigation has to be performed when based on literature, the quantity and the quality of data are not enough to justify the equivalence with another device CE marked and already on the market. In case of a complete new technology or of a new indication of use of an existing device and in case PMCFU are needed.
If the Factory is ISO 9001:2015 certified, is it mandatory that this factory must be certified to ISO 13485:2016 to make Medical Devices Class I?
The MDR does not name any quality standard. However ISO 9001 is not designed for regulatory purposes like ISO 13485. Therefore ISO 13485 should be used for the quality management system related conformity assessment procedures of the MDR. In case the legal manufacturer is MDR + ISO 13485 certified and manufacturing is outsourced to a ISO 9001 certified company the manufacturing cite is likely to be audited within the audit of the legal manufacturer.
How will the products covered by the extended medical device definition in the MDR be treated during the implementation period? For example, which rules and regulations should you fulfill if you would like to gather clinical data on these devices?
Till we haven’t CS and NB won’t be designated there are not specific requirements. In this period it is important to verify equivalence with analogous devices with medical purpose.
Equipment for iontoforesis are classified as cosmetic devices? Could you please provide an example of a cosmetic device for neuronal stimulation?
Most of the iontophoresis devices without an intended medical purpose could undergo within the class 5 of annex XVI. At the moment we are not aware of the neuronal stimulation for cosmetic applications.
To find out more about the EU MDR and its implications for cosmetic devices, watch the on-demand webinar to learn more.