Laser Assessment and CE Marking

If your laser device has a CE mark, you might assume it’s safe-but that’s not always the case. Over the past few years, We’ve seen a growing number of lasers and high-output light-based devices, particularly in aesthetics, that lack evidence of compliance with essential laser safety standards. This is where a proper laser assessment becomes critical.

And it’s not just aesthetics. In sectors like material processing, devices are being sold in the EU that are technically unsafe. Matthew Peach reported this in optics.org, quoting Alexander Kunz from Trumpf Machines Austria, who echoed something I often say: “An increasing number of technically unsafe laser machines are entering the European market. These machines do not meet the European directives and safety standards, even though they bear a CE Mark.”

It’s a common misconception that CE marking equals compliance. In reality, the CE mark is self-declared by the manufacturer. That means you’re relying on their internal processes and understanding of the standards. And unfortunately, not all manufacturers are doing this properly.

Kunz from Trumpf Machines Austria says that “This is not always done with bad intentions, but simply out of ignorance on the part of the manufacturers”, which I would agree with.

This is why a laser assessment by a competent person is so important. It validates whether the CE-marked device actually meets the requirements of the Machinery Directive, Low Voltage Directive, Electromagnetic Compatibility (EMC) Directive, and, if applicable, the Medical Device Regulation (MDR).

In our opinion a compliant device usually comes with something many overlook: proper after-sales support.

A device that genuinely meets standards should come from a supplier who:

Provides full operator training on how to use the device effectively and safely, and this support can often extends to and support when you want to introduce new processes or treatments. Confirm that hands-on and written training is included, not just a 10-minute demo.

Offers documentation, including readable and usable operation manuals. Yes, I know reading op manuals can be boring, but the secret to someone getting the device to work as intended ‘How did you get it to do that?’ is that that person read the op manual!

Can offer on-site servicing and maintenance contracts and supply replacement parts for the lifetime of the device, ensuring your device continues to operate effectively and safely. We have come across situations where the laser owner had to ship their laser for servicing and repairs, which is costly and meant that their device was out of operations for a long period of time. Ideally a service engineer should be able to travel to you.

Provides safe decommissioning when the device reaches end of life or when you want to replace it.

Without these, you’re likely dealing with a device that hasn’t been designed or supported to the expected standard, putting you, your team, your clients and the public at risk.

Market surveillance is under-resourced. CE marks can be misleading. Your laser assessment is a vital step in keeping your patients, staff, and business safe.

Contact us for a free consultation.

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