OEM manufacturing transfers work, not liability. When the red light therapy bed carries your brand and your claims, you are the party the regulator will contact, and in the European Union you are the legal manufacturer in the full sense of the regulation.
That means you own the labeling and instructions for use, the unique device identifier, complaint handling, ettermarkedsovervåking, vigilance reporting, and the ability to execute a field safety corrective action. It also means you need a contractual right to the manufacturing records that a recall would require, because a recall you cannot scope is a recall you cannot run.
Ask about insurance before you need it: what product liability coverage the factory carries, what limits apply, and whether your entity can be named on the policy. Ask what happens if the factory loses a key supplier, changes ownership, or stops producing this platform. A red light therapy bed supplier with a credible answer has thought about continuity; a supplier without one is planning to be someone else’s problem.
