This applies to all equipment supplied for first time use in the EU. It also applies if you have made a substantial change to an existing machine, even if it predates 1995.
The manufacturer is normally accountable for ensuring that this process is followed
For equipment imported into the EU, the importer is accountable
It applies even if the equipment is for self use
It applies to all machinery supplied for first time use within the EU after 1 Jan. 1995, even if the equipment is older than this
For the majority of equipment, the process is one of self-certification (there is no “CE Inspector”).
Failure to follow this process can lead to fines. In cases where equipment is exported to other EU countries, it can also result in equipment being held at customs. Whilst it is primarily an EU requirement, SSS have been asked to provide support for equipment being exported to non-EU countries.
What do I have to do to CE mark a machine?
The applicable regulations are the Supply of Machinery (Safety) Regulations 2008. These require the manufacturer to:
Design and build the equipment so that it complies with appropriate essential health and safety requirements (EHSR’s) and harmonised European standards (HES’s)
Assess the equipment for conformity with EHSR’s and HES’s
Be able to compile a technical file proving conformance
Draw up a declaration of conformity and affix the CE mark to the equipment
Where the machinery is imported for first time use into the EU, the importer has the obligation for doing this.
How can Strategic Safety Systems help?
SSS provide a service where we:
Assess which EHSR’s and HES’s are relevant to the equipment.
Consider each applicable clause within the EHSR’s and HES’s and state how this is met.
Where an applicable clause is not met, we would normally made recommendations on how this could be met by reasonable and practicable means.
Include an assessment to ISO 13849 Safety Related Control Systems which has recently been made mandatory. Some find that this can cause problems because of its complexity, but the SSS system simplifies this..
Provide a risk assessment, if this has not already been done .
Provide a report with all of the above, which forms a significant part of the technical file. This can be supplied as a hard copy and a .pdf file.
Provide a declaration of conformity.
SSS use a comprehensive and unique assessment system where each clause is listed and assessed if applicable.
SSS personnel are chartered health and safety practitioners and have a background in machinery and control system design and manufacture
Benefits
As a result of the services provided by SSS, the supplier will:
Have a report listing all applicable clauses in EHSR’s and HES’s which forms a significant part of the technical file.
Have design input where there are problems meeting any of the above
Have a declaration of conformity, which is the certification that the supplier must provide.
Be legally able to affix the CE mark to the machinery