Frequently Asked Questions (FAQ)

1. I am not a producer. Do my products need to comply with rules and regulations if I want to sell them into the European Union?

The law is very clear on who needs to comply to what within the retail supply chain. According to the New Legislative Framework:

  • Manufacturers needy to draw up, keep and update technical files and declarations of conformities for their products,
  • Importers are required to ensure that a technical file is available and keep a copy of the declaration of conformity.
  • Distributors are required to act with due care.

Everybody involved is required to provide all information and documentation necessary to demonstrate the conformity of the product in a language easily understood by that authority.

2. Which rules and regulations apply to my country?

Within the ProductIP Platform one of the first questions that you will need to answer when starting a technical file, is the country. We advise for you to choose the countries carefully in order to prevent the requirements list to become unnecessary long.

3. Which product category do I choose?

Please note that description of categories may deviate. Translations too. So you will need to try different possible categories before finding the right one for your product. Within the platform it is possible to search by standards. That could be of help to you. If you can not find the product category for your product, please contact us.

4. What is the market release date?

That is the date that determines the applicable requirements. It is best to align with the date on the declaration of conformity. If you have a new batch of the product, this means a new date and also you will need to make a new file.

5. What products can I group in one Technical file?

You can group a range of products only if the manufacturer is the same and if the same requirements list apply.

6. Can I select one product out of a range of similar product to be representative for the whole range?

Yes you can. If the same requirements lists apply for all products. Very often the test laboratory can help you with an assessment whether or not your product is representative for the range.

7. How do I know if a document is authentic and not fake?

Always ensure that your documents are authentic and delivered by a reliable source. In case of doubt please contact us and we will assist you with the validation of your documents by checking with the official testing agencies.

8. Is my product safe to use if it complies to the applicable rules and regulations?

Legislation does not guarantee safe products. We advise you to start with a risk assessment. Also harmonised standards are useful (not mandatory).

9. What is a requirement?

There are different types of requirements:

  • A requirement can be a standard (f.e. ISO 14982:2009),
  • Also it can be an amendment (f.e. EN 60335-1:1994/A12:1996,
  • Lastly it can also be a corrigendum (f.e. NEN_EN 55014-1:2007/C1:2009).

10. How can I see what the expiry date is of the requirement?

In the ProductIP Platform the expiry date is mentioned only when there is a new edition that will supersede the previous one. The date of the new edition is then the expiry date of the previous one.