What is the responsibility of the manufacturer during the type approval process?

The manufacturer’s responsibility during the type approval process prominently includes the obligation to pay for all required tests related to compliance and performance evaluation of their devices. This is essential because the manufacturer retains ownership of the product throughout its lifecycle and must ensure it meets specific standards set by regulatory bodies before it can be marketed.

By financing these tests, the manufacturer demonstrates a commitment to quality and safety, helping facilitate the approval process. Conversely, while it may be possible for manufacturers to conduct tests themselves, they generally rely on independent testing facilities to ensure impartiality and credibility of results. The creation of regulatory standards is the responsibility of governmental or regulatory agencies, not manufacturers, which helps to maintain consistent benchmarks across similar products. Pricing decisions for devices ultimately fall under the manufacturer’s business strategy but are not a distinct responsibility in the type approval context.