Step 6: Continued Compliance
Since 2008, the European Commission requires manufacturers of serial products to install procedures to keep their products in compliance with the directives and with the harmonised standards, even when these are amended after the product has been made available on the EU market. In the CE directives, a clause similarly to the one below can be found:
Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonised standards […], or in other technical specifications by reference to which conformity of [product] is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by [product], manufacturers shall, to protect the health and safety of consumers, carry out sample testing of [products] made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming [product] recalls, and shall keep distributors informed of any such monitoring.
Decision 768/2008
What this means is that manufacturers must monitor the regulatory developments, by regularly checking if there are amendments to the CE directives their products comply with, or whether their products are covered by new directives. This requirement also implies that when European standards that were applied are amended, or when new standards are introduced, the manufacturer re-evaluates the compliance of their products. In other words, CE marking is not a ‘one-time exercise’, but requires continual effort.
The aforementioned provision also implies that a manufacturer maintains a register of customer complaints and where deemed necessary investigates the product safety and performs withdrawals or recalls.
The Product Compliance Manager-platform, and the services that come with it are build with this specific European Union requirement in mind. We offer you the tools that make monitoring continued compliance easy. The only thing you need to do is get access to all features and check in on a regular basis.
- Our staff monitors the announcements of the European regulators on a daily basis. If there are new regulations or standards, amendments to existing regulations and standards or other noteworthy facts. If so, our platform members are alerted through an email alert.
- Our databases are updated, as soon as new documents are published. With color codes we indicate if information and documents are current or repealed.
- In the “My Product Files”-section, we offer you to list the directives, regulations and standards you would like to monitor. When you use this option, you will benefit from a one-glance overview of where you stand, and we can send you targeted alerts when your directives and standards change.
If you have questions or comments, please let us know.