Machinery Regulation - Orgalim calls for the protection of a core pillar of Europe’s Single Market

21 April 2021

Europe’s technology industries have been able to thrive thanks to a strong European Single Market, enabled by Europe’s New Legislative Framework (NLF). Core to that success is the current Machinery Directive.

Today the European Commission published a proposal for a Regulation replacing the current Machinery Directive. Orgalim welcomes the aim to enhance harmonisation and widen the scope of the regulation to cover new technologies.

However, Orgalim has significant concerns about some of the measures foreseen in the package, notably:

  • Self-conformity assessment for high-risk machinery: Orgalim has serious concerns regarding the proposals for mandatory third-party conformity assessments applicable to all high-risk machines. Third-party conformity assessment increases costs, adds administrative burden and time to market. This also links to another proposal released today for a Regulation on Artificial Intelligence (AI)

  • We believe legislation needs to remain future-proof and technology-neutral, allowing industry to remain versatile, agile and innovative. This has helped our companies to become undisputed global leaders in their fields, while maintaining the highest level of safety for their machines. The introduction of new essential health and safety requirements for digital technologies into the legislative text threatens that approach.

  • We are also concerned by the proposal that foresees for the European Commission to develop technical specifications via implementing acts which could grant presumption of conformity in case harmonised standards are unavailable. This could disrupt the incremental idea of the NLF and public-private coordination and will impact the market relevance of standards as well as the inclusive and consensus-based approach to standardisation development.  ​​​​​​​​​​​​​​

We look forward to working with the co-legislators to address these issues in order to guarantee legal clarity, and workability. This will ensure that Europe’s manufacturing base can continue to build on a strong Single Market for machinery, thus protecting one of Europe’s core pillars. 


Notes for editors:

About Orgalim: 

Orgalim is Europe’s largest industry network focused on advanced manufacturing. We bring together 46 associations representing Europe’s technology industries, comprising over 770,000 innovative companies, which directly employ 11 million people across Europe. Our membership spans the mechanical engineering, electrical engineering, electronics, ICT and metal technology sectors across 22 countries. Our industries develop and manufacture the products, systems and services that enable a prosperous and sustainable future. For more information, visit or follow us on Twitter and LinkedIn.


Orgalim Press Contact 

Eugenia Forcat, Director of Communications, Tel: +32 478 403032,