Background: Microneedling devices are being used as a surgical technique without a clear regulatory category. They can become dangerous considering that these kind of devices can easily be bought and used by nonqualified people.
Aims: Our aim has been to demonstrate that microneedling devices used in dermatological surgery are Medical Devices according to the current regulations.
Patients/methods: After a thorough review in the European Union and USA medical device classification, we consider microneedling systems as Class II (US) or IIa (EU).
Results: Therefore, they must follow the regulations established for medical devices. A risk assessment has also been made, in which the technical and scientific deficiencies in their design and manufacturing have been recognized in addition to including compulsory information for the regulatory agencies and most importantly for the final user.
Conclusion: It can be concluded that microneedling is an interesting tool in dermatology although more information related to its safety needs to be submitted. In addition, its use by nonprofessional people does not guarantee the safety of the user.
Keywords: microneedling devices; regulatory affairs; risk factor; safety.
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