Requirements for sleep glasses
What Does It Take to Manufacture and Market Genuine Sleep Glasses in the EU?
At MelaMedic, we often see new online stores and brands appear using our descriptions and concepts. They typically sell ordinary “blue light glasses” as sleep glasses. However, there is a significant difference between cosmetic screen glasses and therapeutic sleep glasses – both in terms of effectiveness and regulatory requirements.
In the European Union, the rules governing optical products that make health-related claims are clearly defined under the EU Medical Device Regulation (MDR 2017/745/EU).
When Are Glasses Considered a Medical Device?
If glasses are sold solely as a fashion accessory or for general screen comfort, they fall under ordinary consumer product legislation.
However, as soon as a product is marketed with claims such as:
- Promoting sleep or alleviating sleep problems
- Regulating the body’s circadian rhythm or alleviating jet lag and similar conditions
- Affecting or stimulating the body’s melatonin production
- Being a sleep aid or “sleep glasses”
the product is legally classified as a medical device. It is unlawful to market or sell glasses with these claimed properties in the EU unless both the company and the products comply with the applicable requirements for medical devices.
What Requirements Must Be Met Under the MDR?
In order to legally manufacture, import and market sleep glasses in the EU, the following requirements must, among other things, be met:
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CE Marking as a Medical Device:
Preparation of complete technical documentation as well as a formal EU Declaration of Conformity.
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Clinical and Optical Documentation:
All claims regarding the product’s effectiveness must be substantiated using evidence relating to the specific product and relevant clinical data. At the same time, the optical filters must be tested and documented by accredited laboratories to ensure that they block the precise wavelengths of light specified.
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Regulatory Registration in EUDAMED:
The manufacturer and importer must be officially registered in the EU database for medical devices, as well as with the relevant national health authorities, such as the Danish Medicines Agency in Denmark.
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Quality Management System (QMS):
A formally established system is required for managing production, traceability and post-market surveillance. A QMS includes, among other things, quality policies and objectives, organisational structure, management reviews, resource management, risk management plans, product safety analyses, production controls, risk assessments, product specifications, product analyses, user analyses, product changes, document control, technical documentation, process validation, traceability, labelling procedures, product evaluations, regulatory reporting, non-conformity procedures, root cause analyses, and ongoing inspections and audits by the Danish Medicines Agency.
Documented Quality Rather Than Imitations
When you choose sleep glasses from MelaMedic, you are choosing products that have been developed, tested and approved in accordance with the applicable legislation governing medical devices.
This is your assurance that you are receiving a product with a genuine, documented effect on your sleep and health.