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Why Choose Us
For almost 20 years, we have been supporting companies in overcoming the complexities of European and international regulations. We provide tailored technical and legislative consultancy, guiding our clients through every stage — from product design to full regulatory compliance. With offices in Europe and China, we ensure fast, reliable, and secure solutions to facilitate market access and strengthen business competitiveness.
20
Years of experience
600
Annual Consultancy
1500
Annual Technical Files
2000
Annual AQL Inspections
Our Services
European Products Compliance
Products Quality Inspections
Training
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Strumenti Qualità e Misure srl
Frequently Asked Questions
What is the European conformity of a product?
What is the CE marking?
Which products require the CE marking?
The CE marking is mandatory for various products, including:
- Medical devices
- Toys
- Electrical and electronic equipment
- Construction products
- Machinery
- PPE (Personal Protective Equipment)
- Measuring instruments
How is CE conformity obtained?
The process varies depending on the product and the applicable legislation, but generally includes:
- Identification of applicable directives and harmonized standards
- Conformity assessment (laboratory tests, risk analysis, etc.)
- Preparation of the technical file
- Drafting of the EU Declaration of Conformity
Affixing of the CE marking
Who is responsible for CE conformity?
The manufacturer is primarily responsible, but importers and distributors also have verification obligations before placing a product on the EU market.
Which documents are required to demonstrate conformity?
- Technical file (including drawings, diagrams, tests, and risk assessments)
- EU Declaration of Conformity (signed by the manufacturer)
- Certificates from notified bodies (if required by legislation)
Can a product without the CE mark be sold in Europe?
No. If a product falls within categories subject to CE marking, it cannot be sold within the EU without conformity.
What happens if a product is non-compliant?
Market surveillance authorities may:
- Prevent the product from being sold
- Withdraw it from the market
- Impose sanctions on the manufacturer, importer, or distributor
Where can I find the applicable EU legislation for my product?
EU directives and regulations are available on the European Commission’s website and in the standards documents issued by organizations such as CEN, CENELEC, and ETSI.
What is the difference between directives and regulations?
- Directives: Must be transposed into national law by each EU Member State.
- Regulations: Are directly applicable throughout the EU without the need for national implementation.
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