On the 21st of April the proposal text for the new Regulation on Machinery was presented by the European Commission. The revision of the current Machinery Directive resulting in the new Machinery Regulation, is aimed at contributing to both the digital transition as well as strengthening the single market. The main legal changes of the proposal are summarized in this article.
Transition from Directive to Regulation
The transition from Directive to Regulation facilitates a homogenous application throughout the EU. As a result of the change of Directive into Regulation the legislation no longer needs to be transposed into national legislation by all Member States. Instead, the Machinery Regulation will have a direct effect. All countries in the EU will have the same legislation and it can be imposed directly. Therefore differences in implementations between EU member states will disappear.
Adoption of the New Legislative Framework
The transition to the new Regulation involves incorporation of the New Legislative Framework in the Regulation. The New Legislative Framework is aimed at improving market surveillance and boosting the quality of conformity assessment, as well as providing clarification on the use of CE marking and creating a toolbox of measures for the use in product legislation.
New technologies and developments
One of the main pillars for the revision of the current Directive has ensured that new technologies are covered by the new Regulation. Aspects such as artificial intelligence (AI)
, machine learning and internet of things (IoT) are covered by the new proposal Regulation.
Modernized definitions and working scope
The new proposal Regulation adds the legal expression, ‘substantial modification’, referring to modifications affecting the compliance of original machinery. In this case the modifier will have the legal obligation and responsibility to conduct a conformity assessment. The Regulation proposal also introduces a list of ‘high-risk machinery’, which replaces the old list in the Directive previously mentioned under Annex IV. Conformity assessment of this machinery will require validation by a third party (notified body).
The legal and technical regulatory specialists of MAAK Attorneys and Certification Company will keep you updated on all major developments with regard to the revision of the Machinery Directive.
Would you like to explore the impact of the revision of the Machinery Directive on your company, the design of new machines, the sale of machines or the use of machines as work equipment, please do not hesitate to contact us.