Product Compliance Resources provided by ProductIP

2021-03-22

Why ProductIP is as it is

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

"Oh, this ProductIP way of working is too complex. Too many steps we must take. Too many requirements. That list is way too long."

So why did we build ProductIP this way? It is not to make your life miserable. It is the opposite. The European legislation has created the legal structure, at ProductIP we make the legal framework as easy as can be.

The legal structure follows the European legal framework for manufactured goods, also called non-food consumer goods. One of the aspects that drives the European economy is the free movement of goods. To achieve this growth, we have to remove trade barriers. Replace national legislation with EU (harmonised) Legislation. Legislation agreed upon by all the Member States. Mandatory product certification per Member State was also such a trade barrier. The self-assessment principle confirmed with an EU DoC, a "CE declaration", was born.

The basis of the EU product legislation is self-assessment for economic operators, under the presumption that the economic operator knows the product best. The legislator sets certain requirements for products. For example: a product must be safe, or a product may not contain certain chemicals. An economic operator's task is to meet these requirements. Self-assessment brings freedom of trade but comes with responsibilities and a mandatory number of things to do:

  • Do a risk assessment considering the expected use of the product
  • Establish the scope of applicable legislation
  • Make a list of relevant harmonised standards
  • Find out if there are still applicable national standards
  • Type test the design of the product
  • Map the used components, materials, substances
  • Map the flow of production, incoming quality control, during production quality control, final quality control
  • Perform appropriate random checks on to be released mass production
  • Take your extended producer responsibility where applicable
  • Operate a post-market surveillance programm
  • Instate corrective actions based on findings

This process leads to an assumption of compliance so that you can declare compliance with essential requirements (CE).

This "assumption of compliance" is essential for your liability. When things go wrong and given the quantities of products placed on the market, things sometimes go wrong; you notify the authorities and cooperate with them. In such a case, you want to demonstrate your efforts to place compliant products on the market! A loose set of e-mails, documents in some folders, flaws in packaging is not a structured approach. Using ProductIP is. 

Is this new for you? Perhaps now is the time to do some self-reflection around product compliance principles. Reading the European Union "Blue Guide" would be an excellent next step. 

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