New Regulation For the Machinery Directive in Europe

Within this programme existed a report on the impact of new technologies and the various challenges they pose to EU safety legislation. Within this, a number of gaps were identified, especially within the Machinery Directive.

As technology advances within the machinery sector, especially with technology that uses artificial intelligence (AI), so too has it been identified that there are many legislative gaps that require addressing. The Machinery Directive was identified as such.

What does the revision entail?

The revision, among other things, aims to

• Address the risks stemming from new technologies while allowing for technical progress
• Simplify the requirements for documentation by allowing digital formats and therefore reducing administrative burdens on economic operators and reducing environmental costs
• Improve the legal clarification of some major concepts and definitions that exist in the current text
• Ensure coherence with existing Directives and Regulations for products to improve the enforcement of the legislation through the alignment to the New Legislative Framework
• Reduce costs of transposing by converting the Directive into a Regulation

How will the new regulations be enforced?

Much like the new Artificial Intelligence Regulation, businesses will be subject to Market Surveillance requirements including post-market monitoring through audits. Independent notified bodies may also be required to be involved in a Conformity Assessment Pocess.

Before a manufacturer can begin the required procedure to assess their product for conformity, it is important that they determine whether their product allows self-assessment or if a Notified Body needs to be involved.

A Notified Body is an organisation which is responsible for carrying out required conformity tests to assess products before they are released to the EU market. These bodies are designated by individual European Union member states.

Most of the equipment which fall under this directive can be self-assessed by manufacturers. So long as the equipment complies with the directive, manufacturers need not approach a notified body.

In addition to this, EU Member States will be required to enforce the regulation by designating one or more national competent authorities to supervise the application and implementation of the protocols.

What does the new regulation mean for businesses?

Businesses within the machinery sector should ensure they stay up to date with the latest information surrounding the Directive and that they appoint an Authorised Representative to ensure their products are compliant.

Essentially, the Machinery Directive revision is being implemented to guarantee the safety of consumers and encourage innovation, so that we are better equipped for the future.