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A couple of days ago, we attended the talk organized by @Fenin related to Products Without Medical Purpose to which the Regulation (EU) 745/2017 on Medical Devices applies. The talk was really good and clarified doubts that many of us had regarding these products.
These are the conclusions we drew from the talk:
1. THEY ARE NOT MEDICAL DEVICES. They really cannot be classified as such, but the MDR Regulation DOES APPLY to them, which means this is more of a conceptual issue.
2. The MDR does not apply in any way to the accessories of these products. This is clear (for now).
3. There are many doubts in the interpretation of how the rules of active medical devices apply to this type of products.
4. Although the MDR comes into force on May 26, 2021, it will not apply to products in Annex XVI until the common technical specifications being developed come into force. And this will be on November 26, 2021 (work is underway to extend the deadline).
5. AEMPS is also working on including some of these types of products in the operating license. Manufacturers of non-medical purpose contact lenses and instruments for tattoos, permanent or semi-permanent makeup are already included, but they will likely expand to more manufacturers, importers, sterilizers, or assemblers of these product groups.
In general, it was also mentioned that AEMPS is in the process of drafting a Royal Decree that includes the requirements of the Regulation and those of Spain concerning medical devices. It will be published throughout this year 2021. It was also mentioned that another Royal Decree is being drafted to establish advertising requirements for medical devices. It will also be published in 2021.