What does a manufacturer do?
A manufacturer is responsible for designing and making a product, or having a product made. The manufacturer sells the product to an importeror distributor. Use the decision tree to find out your role for each product.
1. Check if your product is already banned in the EU
Check on the EU platform Safety Gate if the product you are going to make is banned in the EU. Safety Gate has a list of all products banned in the EU due to serious risks. Also check if Safety Gate lists banned products which have the same properties as your product.
2. Design and manufacture your product according to safety requirements
You should design, manufacture, and test your product according to the standards and guidelines that apply to your product. For instance, the guidelines for toys, cosmetics, or electrical appliances. Different safety rules apply to each product category. If your product consists of different parts, the product may come under more than 1 category. For example, a toy that has a battery comes under both the requirements for toys and the requirements for electrical appliances.
Hire a consultancy agency
You need specialist knowledge for this step. Are you a small or medium-sized entrepreneur? Then it is usually wise to hire a consultancy agency. This can help you comply with all requirements.
3. Create a technical file
You must keep a technical file that contains all important information about the product. For example, the technical file contains information on:
- use of the product
- the design
- production
- the operation
- the traceability
- markings, labels, and user information
- risk assessments
- checks carried out and test reports
- certificates
You must show this file to the supervising authorities during an inspection or check. You may decide on the form of the technical file. You can also make your technical file available online.
Be careful with product adjustments after manufacture
Are you having a product manufactured by another company? Or do you import it? And do you modify the product before selling it? For example, by putting your logo on the product. By law, you are then considered the manufacturer. This means, for example, that you are responsible for the technical file. You must have it made and make it available.
4. Apply CE marking and EU declaration of conformity
You must put CE marking on certain products. This certifies that your product has been checked and meets the product safety requirements. Check the overview of product groups that must have CE marking. Is CE marking mandatory for your product? Find out how to apply CE marking with the CE marking checklist.
You must create and sign an EU declaration of conformity. This says that your product meets EU requirements and that you are responsible for it. You must translate the EU declaration of conformity into the required language(s) of the EU country where your product is sold.
After this step, your product can be put on the market.
5. Keep checking the safety of your product
Make sure that all products you make continue to meet the requirements set out in the technical file. To do so, you can set up a quality control system. For example, you can take random samples and check if the product is still safe. This shows that the product still conforms to the requirements.
6. Keep track of changes to product requirements
Your product must comply with the product requirements at the time you put the product on the market. If you put a new batch onto the market, you must check, or have it checked, whether EU legislation or product standards have changed. If so, your product must comply with those new requirements.