As the demand for light therapy devices grows, and the industry along with it, widespread call for regulation within the field has been made. Until previously, many light therapy devices have been unable to be classified or covered by any particular European regulation or directive. However, earlier this year, EU Medical Device Regulation 2017/745 entered into force, and with it came an amendment to Directive 93/42/EEC introducing changes for light therapy devices making certain claims.
Under the new Regulation, a new term of classification was introduced to cover light therapy devices, along with a host of other types of device – Aesthetic Devices. The term “Aesthetic Device” is roughly defined in the Regulation as any device or product “without an intended medical purpose” claiming medicinal effects or outcomes. This caveat was introduced as a means of upholding and enforcing health and safety standards of previously uncontrolled aspects of public health. In the case of light therapy devices, the implications of the new Regulation are that any device claiming a medicinal or health benefit, though not necessarily required to substantiate these claims, will be obliged to comply with all guidelines laid out by the Regulation.
Manufacturers of red or blue light therapy devices in particular may potentially be affected by the new Regulation as these devices fall under the newly installed “Aesthetic Devices” classification. This is the case as both red and blue light therapy devices often make medicinal claims. Red light therapy devices often claim to ease joint or muscular pain, osteoarthritis, acne, tissue damage, or neurological damage, as well as having certain anti-aging properties. Similarly, blue light therapy devices have been linked to claims of killing bacteria, helping prevent fatigue or depression (as a result of increased vitamin D and serotonin production in the body), as well as increasing alertness and boosting the metabolism.
On account of these claims, red and blue light therapy devices – or more correctly, the red and blue light therapy devices which make these claims – must comply with Regulation 2017/745. It is for this reason that manufacturers are strongly advised to consider the impact of their products claims or definitions, as well as their implications, before attempting to bring a product to the EU market.
For more information on European Regulation 2017/745, the compliance route for products affected by the directive, or for regulatory advice, contact Obelis today.