1. I want to import and or sell products to consumers in the European Union? What do I need to do?
All the roles and responsibilities for importers, manufacturers, brand-owners, retail and e-commerce (distributors) even for market surveillance authorities have been arranged in what is called the New Legislative Framework.
Check our “Your Roles Versus ProductIP” to see what your legal obligations are and how using ProductIP enables you to deal with them.
2. Are there only EU rules or also National Rules?
For most of the products the regulation is the same across all the EU member states for most of the products; however, national laws and or standards can be applicable in specific cases. The good news is that we keep track of both European and National legislation. One of the first questions that you will need to answer when starting a technical file is to select the countries in which you plan to make the products available.
3. Do you cover my product?
The advantage of ProductIP is that you don’t search on complicated things such as legislation, but you start with something you do know: the type of the product. A router, a table, a napkin. Our scope is non-food consumer products*, and we aim to be as complete as possible. You can search our database via entering the product category type, you can also upload a picture of the product. Next step is to select the product from the search result. Different products may lead to different follow-up questions, which we try to make as easy as possible for you to answer as well.
* no food, no plants, no pets, no pharmaceutical, and no high-risk products (industrial or medical) that require type approval by a Notified Body.
4. What if my product is not in your database?
You can always start a file by using the product category [ PROVISIONAL ]. When you use the provisional product category, a member of the ProductIP expert team is alerted and will look into your technical file and investigate if there’s an applicable product category. We request that you upload all information you already have available to the Documents tab, that is helpful for us to determine the right product category for you.
If there is not an applicable product category we will investigate and create of product category for your product. This process usually takes 3-5 workdays. We will send you a message through the timeline (3rd tab) of your technical file for the product to keep you informed.
5. Why is the market release date important?
Products need to be in conformity with the legislation that is applicable the moment that they are placed on the market.
Placed means: Importing. The market means The European Union. One of the unique features of our database is that it allows you to create a requirement list that is relevant on a specific date, the intended date you want to place the goods on the market.
This does not have to be the exact date; it can be roughly around that date. Using the shipping date is common.
Did you know that ProductIP also enables you to create a requirement list for a date in the past? This can be relevant for when you get questions from customers or authorities about a batch imported in the past.
6. Do I need to make a technical file for each shipment?
You need to be able to demonstrate compliance each time you place products onto the market.
We continuously monitor the relevancy of the requirement list in technical files. We look 90 days ahead and indicate if new requirements have become available, or even mandatory.
The most organised way to work is to create a CLONE of the file with a new market release date to collect, review and organise new compliance evidence, and move the current technical file to the archive.
Working in existing files is not recommend. This makes it complicated if not impossible to demonstrate your efforts to certain shipments over time.
7. Can a technical file in ProductIP cover an article range?
You can group a range of products, a family, into a single technical file, at no extra cost. You can compare this with the way testing and certification institutes combine a range of products on one certificate.
A technical file is connected to one only supplier. Different suppliers means different entities, with other vendors, other quality control systems, therefore different technical files.
8. How do I know if a document is authentic and not fake?
Laboratories and certification institutes issue original certificates in PDF format. In case of doubt, contact the issuer or please contact us and we will assist you with the validation of your documents by checking with the official testing agencies.
9. Is my product safe to use if it complies to the applicable rules, regulations, standards?
The principle of the New Legislative Framework is that if you follow the correct assessment route products are intended to comply.
First step. Start with a risk assessment. We have included smart forms for that in each file. We look at potential risks for specific product categories, we combine this with what happens in the market (real recall cases) and present you with, again, a range of questions with 3 basic answers possible:
Second step. Compliance with relevant product standards. Preferable harmonised (the same in all the EU union states)
Third step. Monitor if compliance is maintained during mass production. Ask for (summary) reports of the factories quality assurance activities. Arrange (random) inspections on various aspects.
Last but not least. Look at responsibilities that are relevant when making products available to consumers, so-called extended producer responsibilities: proper markings/instructions in the native language of end-users, joining recycle programs for packaging materials, electronics, batteries, etc.
10. I see different type of numbers at standards. What is the meaning?
It starts with a letter related to the organisation that issued it, followed with a reference number and a year, for example, ISO 14982:2009
ISO - International Standards Organisation
EN - European Norms
IEC - International Electrotechnical Commission
ETSI - European Telecommunications Standards Institute
Standards can be amended at a specific date. For example EN 60335-1:1994/A12:1996, means that there is an amendment A12 issued in 1996. Amendments will become mandatory at a specific date which is clearly listed in your technical file.
You will also see corrigendum, for example, NEN-EN 55014-1:2007/C1:2009. These are textual changes of the original document. You may assume that laboratories and test institutes always have taken care of information in corrigendum even if they did not mention them on a certificate or test report.
11. Do you warn me when things change?
We automatically monitor the requirement list in all files. In the overview of your technical files, you instantly see if the requirement list is still relevant for an upcoming order.
Inside each technical file, there is a requirement list. If there are two versions of the standards valid you can choose which one you want to use. The expiry date is mentioned in the overview.