Multiple lab involvement in a conformity assessment process – Labshare MEETUP Summary

How are new products tested before they are introduced to the European market, and what roles do laboratories play in their assessment? This was the main topic that Gábor Tasnádi, the managing director of CerTrust covered in his presentation titled “Multiple laboratory involvement in the conformity assessment process”.

Tasnádi started by explaining that before goods can enter the market of the European Union, they must fulfill the Essential Safety Requirements (ESR). This harmonized legislation sets out the requirements for products.

To obtain the CE mark for health, safety and environmental conformity, goods are subjected to a markedly thorough conformity assessment process, in which a so-called notified body must be involved. CerTrust itself is a notified body for the directives and regulations on pyrotechnic articles, explosives for civil use, gas appliances, machinery, electromagnetic compatibility and radio equipment.

“At the end of the conformity assessment, they issue a certificate, which is a passport for the European market” - Tasnádi explained. At this stage, the notified body issues a certificate based on the test report and the assessment report.

Drones are a good example of a complex assessment process, since in their case there are numerous European legislations to comply with, from those that apply to unmanned aerial systems to specific parameters regarding EMC testing for the radio equipment.

Notified bodies shall involve laboratories locally for accreditation and to provide testing when requested by the authorities or by the applicants in Europe. However, if the manufacturer is located outside of Europe, it is preferred to carry out the tests locally, near the location of the manufacturer.

“To sustain such a complex laboratory network for the notified bodies is usually economically unviable. Therefore, the solution is sharing the capacity of existing specified laboratories. In the future, this will be more and more the case, as technologies will be more complex and for the products there will be many European legislations to comply with” - Tasnádi concluded.