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Compliance vs Conformance: Understanding Italy’s Regulatory Requirements
In Italy, compliance and conformance are crucial concepts for manufacturers seeking to place their products on the market. The technical documentation, a key component of this process, provides essential information on product design, manufacture, and operation.
Preparing Technical Documentation
Manufacturers must prepare the technical documentation before placing a product on the market, ensuring it includes all necessary details to demonstrate conformity with applicable requirements. This document is then made available to market surveillance authorities upon request, and kept for 10 years from the date of market entry.
What Should Be Included in Technical Documentation?
The technical documentation serves as proof that a product meets essential requirements, justifying the affixation of the CE marking. It should include information such as:
- Manufacturer details
- Product description
- Identification numbers
- Facility addresses
- Conformity assessment procedures
- EU declarations of conformity
- Labels
- Instructions for use
- Relevant regulations
Maintaining Technical Documentation
Manufacturers must be able to demonstrate where and how various parts of the document are held and maintained. While language choices are usually flexible, market surveillance authorities may request translations depending on the country of market entry.
Risk Assessments in Technical Documentation
Risk assessments are also a critical component of technical documentation, as manufacturers must identify potential risks and explain measures taken to address them. This includes applying harmonised standards where necessary.
EU Declaration of Conformity
The EU declaration of conformity is a mandatory document signed by manufacturers or their authorized representatives, taking full responsibility for product compliance with applicable EU law. This document should include information such as:
- Manufacturer details
- Product identification
- Statements of responsibility
- Means of product traceability
- Relevant legislation
Imported Products and EU Declaration of Conformity
For imported products, importers must ensure the presence of an EU declaration of conformity and keep a copy for 10 years after market entry. Manufacturers must translate this document into required languages for the country of sale.
Conclusion
Italy’s regulatory requirements emphasize the importance of compliance and conformance in ensuring consumer safety and product quality. By understanding these requirements, manufacturers can navigate the complex process of bringing products to market with confidence.