10/26/2021 | News release | Distributed by Public on 10/26/2021 03:22
26 October 2021
The mandatory third-party certification on so-called "high-risk" machines is unjustified and disproportionate
In this series of four articles, we will provide 7 facts that demonstrate why some of the supporting arguments mentioned in the European Commission Impact Assessment are unjustified and disproportionate.
Today, when harmonised standards cover all relevant essential health and safety requirements, manufacturers of so-called 'high-risk' machinery can either self-assess conformity or use a third party (known as a 'Notified Body') to do so.
The proposed new Machinery Regulation removes the self-certification possibility, making third party certification mandatory for all machinery products listed in Annex I.
However, the supporting arguments in the European Commission Impact Assessment mainly rely on subjective assumptions not confirmed by any data, and an incomplete measurement of the effects. The proposal is therefore unjustified and disproportionate, as demonstrated below.
Third party certification is about assessing conformity and is not a substitute for enforcement and control by market surveillance authorities
Third party certification does not guarantee conformity: some machines certified by Notified Bodies are also found to be non-compliant by other authorities
Notified Bodies' levels of competence and knowledge vary considerably.
Third party certification increases time-to-market, which is incompatible with faster innovation cycles and the seasonal character of certain machinery products
Manufacturers' experience shows that Notified Bodies oftenstruggle to risk-assess or support the development of appropriate new safety concepts for new technologies (such as AI) or new types of products
Access here the list of seven arguments supporting our views that the mandatory third party certification of the so-called "high-risk" machines is unjustified and disproportionate.
This is the third article in a series where we...