From our side as a company that builds these systems, buyers often ask whether we must prove skin safety through biocompatibility evidence for medical devices 1, or if a CE or FDA mark alone already covers everything. Suppliers of shockwave therapy machines are not always legally forced to hand over a stand-alone “skin-safety report”, but […]
From our position on the production side, we often see buyers uncertain about whether shockwave therapy machines must follow the EU’s updated Packaging and Packaging Waste Regulation when entering the EU market. Yes, shockwave therapy machines must comply with the EU Packaging and Packaging Waste Regulation because all packaging placed on the EU market—regardless of
English English 
Español de México
Deutsch
Français
العربية
Русский
