Machinery CE Marking
The CE marking process for machinery is a complex one, for example there are potentially twenty one EU directives that could apply to machinery, but normally there are no more than three to six of them on a frequent basis for an average machine. However there are countless standards that can apply to machinery, as well as many local and regional sets of individual country regulations to adhere to.
We can help and support machine builders and OEMs (Original Equipment Manufacturers), with the original CE Marking of new machines, or the re-CE Marking of machinery that they have substantially modified or refurbished, and similarly, for ‘End-Users’ of machines, we can support the CE Marking of newly created ‘complex assemblies’, the re-CE Marking of machinery that has been substantially modified or manufactured ‘in-house’, as any machines built in-house for the end-user’s own internal use still legally require a CE mark.
The process is complicated, and a thorough knowledge of all the applicable directives, regulations, standards and legislation is essential to get it right, to enable a machine to be appropriately certified, and a legally valid CE mark applied. Our consultants are highly experienced in the specific requirements of the CE marking process and can help right from the start of a machine build project to ensure safety and compliance, specifically helping to ensure that the ‘Essential Health and Safety Requirements’ of the Machinery directive 2006/42/EC will be met. We can do this with the provision of design support from the outset, the design and build risk assessment*, verification of compliance to the standards during the build, through to the final verification of compliance with all the applicable standards and regulations, and the creation of the Declaration of Conformity or Declaration of Incorporation at completion.
* OEMs and Machine Builders should note that the latest EU published formal guide to the machinery directive v2.1, now states that HAZOP studies, FMEA studies or similar assessments no longer provide compliance to the machinery directive, and that a formal ‘Risk Assessment’ under the scope of EN ISO 1200: 2010 – Safety of machinery – General principles for design risk assessment and risk reduction, is the only acceptable form of assessment to gain compliance to the directive…
We can also help and support the creation and assembly of the technical file for the machine that is legally required by the Machinery Directive 2006/42/EC. We do this by ensuring the technical file contains all the appropriate information to verify the CE mark – and which must be retained by the machine manufacturer for 10 years after the machine was built.
A quick word on the ‘B’ word – Brexit… and the CE Marking of machinery in the UK.
Our exit from the EU will have an impact on the way we build, certify and export machinery to the EU or build, certify and retain in the UK for our own use.
A recent comment from the UK government was a ‘signal’ that they were “in no hurry to create a new certification process for machinery being used in the UK”. The statement ‘suggested’ that the current CE marking process would be retained ‘as is’, and instead of applying a CE mark to the machine, they may choose to legislate initially for the application of the old BS kitemark in the short term.
This would make sense so as not to reinvent the wheel, and also to prevent the UK from having two different machinery certification processes to adhere to as this would substantially increase costs – especially when machinery is one of our major exports. Likewise if a new UK machinery certification process was implemented, then machinery made outside the UK would become subject to it making machinery imported into the UK more expensive.
This scenario or approach may have been partially confirmed by an article publish in the Financial Times on 15th June, whereby it was reported that the UK is to apply to stay in the European standards system for industry products and services after Brexit. This followed warnings from business that creating British-only benchmarks would be “an isolationist move” that would pile costs on to companies, and the UK Governments Business secretary Greg Clark has backed moves to keep the UK as a full member of European standard setting bodies such as CEN and Cenelec etc.
But to date – still no one knows exactly how things will work out, so lets hope some level of common sense will continue to prevail. In the mean time we need to carry on as before with CE marking until a formal announcement is made by the UK government.
Further update coming soon….