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EU Machinery Regulations have changed

Machine Safety regulations in Europe are changing. Here’s everything you need to know…

November 22, 2023

Here at pm Connections, we like to remind our clients that in the seemingly ever-evolving world of health and safety compliance, change is the only constant. 

With that said, if you haven’t heard – the Machinery Directive 2006 / 42/ EC is being replaced by the Machinery Regulation (EU) 2023 / 1230. But what does this mean for you? How will this affect your operations? And more importantly, what do you need to do next?

Stay tuned to find out…

Firstly, who is affected by these Machinery Regulations changes?

As we delve into the specifics of the regulatory changes, it’s crucial for us to identify exactly who will be impacted. Those who need to be aware of the changes include:

  • Machinery manufacturers
  • Importers and distributors across the EU
  • Conformity assessment bodies
  • End-users of machinery 

Why have these Machinery Regulations changes been introduced?

The switch from the Machinery Directive 2006/42/EC to the Machinery Regulation (EU) 2023/1230 marks a significant shift in the European regulatory landscape. This change, set to fully come into effect by 2027, aims to harmonise safety standards across the EU, reducing inconsistencies and ensuring a higher level of safety for all.

What are the key changes in the Machinery Regulations?

One of the most notable changes is the move from a directive, which required individual member states to interpret and implement their own laws, to a regulation that is directly applicable in all EU countries. This means a more uniform set of rules for manufacturers, distributors and users of machinery. 

We consider this to have several benefits for manufacturers:

  • Eliminated uncertainty regarding what your responsibilities are
  • A reduced burden to correctly interpret vague/unclear guidelines
  • Reduced admin time 

So, what’s new? An overview of some of the changes:

Despite these benefits, manufacturers will face a new set of responsibilities and requirements to familiarise themselves with. Whilst these are lengthy and may take some time to familiarise yourself with, we’ve summarised some key points here:

Articles and appendices

Firstly, the order of articles and appendices will change. For example, machinery which previously required a notified body to be involved in the conformity assessment procedure had been called ‘Annex IV machinery’ – this will be regulated by Annex I in the future. There are various other changes to the procedures for ‘high-risk machinery’, too. 

Printable vs. digital instruction manuals

Secondly, in today’s digital world, the new regulation has adapted accordingly. Manufacturers will now have the option to provide digital instructions for certain machinery, though they must be printable and readily accessible. 

Further restrictions include: 

  • Printed instructions must be provided if requested
  • Printed instructions are mandatory for ‘non-professional users’ (i.e. general consumers)
  • Both digital and paper instructions must still be provided in the official language of whichever EU member state the product is sold.

After-sales responsibilities are increased

Additionally, post-sale responsibilities are getting more stringent. If there’s reason to believe that a machine is non-compliant or unsafe, manufacturers will be obligated to take corrective action, which could range from issuing updates to outright recalls.

Artificial intelligence

A further new addition to the updated regulation is the inclusion of rules regarding Artificial Intelligence. Specifically, self-evolving machines that are designed to operate with varying levels of autonomy. Some specifics include:

  • Self-evolving machinery must be able to respond adequately and appropriately to the operator and be able to communicate its planned actions in a comprehensible manner. 
  • Its control system must be designed in a way that will not cause the machinery or a related product to perform actions beyond its defined task and movement space. 

Preparing for the Machinery Regulations changes: 

So, what should you be doing now? First and foremost, if you haven’t already, start familiarising yourself with the new regulation. Understand how it differs from the previous directive and what new categories or requirements might apply to your machinery.

For those in the manufacturing sector, it’s time to review and possibly update your conformity assessment processes. Ensure your technical documentation and safety procedures are up to scratch. If you’re unsure, seeking professional advice from a qualified team such as ours, might be a wise move.

At pm Connections, we’re committed to providing you with the latest information and guidance to navigate these changes effectively. Remember, in this world of continuous evolution, staying ahead is not just about compliance – it’s about commitment to safety and quality.

So, if you’ve got any questions or are unsure about what these changes mean for you – please reach out to our team by giving us a ring on 01925 649 818 or dropping us a message here.

PS. Want to read through the new changes yourself? Check out the full document, here.

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