What is a medical device according to the MDR

[@aniawo5119]

Smashing presentation, thank you!

[@f.s.9833]

Prescription glasses are classified as class I. However, what about glasses that are not prescription glasses and are used solely for cosmetic purposes? I would say they aren’t classified as a medical device. And something I am wondering is what about smart glasses. They would contain software and could show your pulse, etc if they were connected to your Apple Watch. How would you classify those? Are they still class I or are they automatically class IIa? Would you classify them the same whether these are prescription smart glasses or glasses without prescription that are smart glasses too?

[@tommyluke5952]

Smart glasses or fitness watches that can measure your vital signs etc are not automatically classified as medical devices, unless the manufacturer claims that they can be used for the purpose of diagnosing, treating and interfering with medical decision and treatment.

[@AnaPaula-ig5uf]

Very clear explanation. Thank you