Meaning
Conformity assessment procedures based on internal production control allow a manufacturer to demonstrate that a product fulfills the applicable legislative requirements. Module a places the responsibility for compliance entirely on the producer without requiring the mandatory intervention of a notified body. This procedure provides the fastest route to market for low-risk equipment.
Internal Control
Manufacturers perform all necessary checks and inspections to ensure the product meets technical standards. Under module a, the producer stays responsible for the design and the manufacturing stages. This involves creating a system to ensure that every unit produced is identical to the design that was evaluated for safety.
Technical Documentation
A file containing all the evidence of compliance must be prepared and held for inspection by authorities. The documentation for module a includes design drawings, component lists, circuit diagrams and the results of any tests performed. These records prove the product was designed according to the rules and remain available for a decade.
This ensures that any safety concerns raised later can be investigated using the original design data.
Declaration Process
The final step involves signing a formal statement that the product complies with all relevant directives. By completing the requirements for module a, the manufacturer takes full legal liability for the performance of the device. This declaration is signed by a senior company official.