The applicability answer is incomplete until the operator role is identified. The GPSR defines manufacturers, authorised representatives, importers, distributors, fulfilment service providers, and other persons subject to duties for manufacturing or making products available on the market.
Role classification changes the answer. Manufacturers carry the design, internal risk analysis, technical documentation, identification, instructions, complaint, accident, and corrective-action duties. Importers check manufacturer compliance and keep technical documentation available. Distributors verify required identification, address, instruction, and safety information before making products available. A person who places a product on the market under its own name or trademark, or modifies it in a way that meets all three Article 13(3) criteria, is treated as the manufacturer for GPSR purposes.
For the Article 13(3) modification test, confirm that the change affects product safety and meets all three conditions: it was not foreseen in the initial risk assessment; it changes the hazard, creates a new hazard, or increases the risk; and it was not made by consumers themselves or on their behalf for their own use. Record the affected part and whether the change affects the safety of the entire product, because that determines the extent of the manufacturer's duties.