Definition and classification of glasses
Die Glasses are devices used to correct vision defects as well as to protect the eyes. They typically consist of two lenses held in a frame that are worn in front of the eyes. In the legal context, glasses are not only a medical aid, but also an object subject to a wide variety of statutory provisions, ranging from medical device law and social law to employment law, insurance law, and traffic law aspects.
Glasses under medical device law
Definition as a medical device
According to Section 3 No. 1 of the Medical Devices Implementation Act (MPDG), glasses are considered a “medical device” because they are intended to detect, prevent, monitor, treat, or alleviate diseases. They are therefore subject to the regulations of the Medical Devices Act (MPG), which has been supplemented and partially replaced across Europe by Regulation (EU) 2017/745 (Medical Device Regulation, MDR).
Placing on the market and conformity
Manufacturers of glasses must meet extensive quality and safety requirements. Placing glasses on the market is tied to a so-called conformity assessment. Glasses are subject to the CE marking requirement under the MDR. Additional documentation and information obligations apply to individually tailored visual aids, such as glasses with prescription lenses.
Retention obligations and traceability
According to the MDR, retention periods for manufacturer and adjustment data are stipulated to ensure traceability in the event of damage or liability. Opticians as ‘distributors’ within the meaning of the MDR are also obliged to retain relevant evidence.
Social and insurance law aspects
Benefit entitlement under statutory health insurance
Under German law, glasses are considered aids within the meaning of Section 33 SGB V. An entitlement to provision exists if the glasses are necessary to ensure the success of medical treatment or to compensate for a disability.
Entitlement and requirements
A claim for cost coverage generally exists only for children and adolescents up to the age of 18, or for adults with severe visual impairment. A medical prescription is required. Statutory health insurance (GKV) covers the costs for standard lenses in basic versions, but not for fashionable frames or special features.
Co-payment and personal contribution
Pursuant to Section 61 SGB V, insured persons are obliged to make a co-payment for glasses, but at most the cost of the aid itself; children and adolescents are exempt from co-payment.
Private insurance law
In private health insurance (PKV), reimbursement depends on the individual insurance contract. Often, fixed maximum amounts or percentage reimbursements apply to aids such as glasses.
Employment law provisions
Display Screen Equipment Ordinance
Employees who regularly work at display screen workstations have the right, under Section 3 (3) of the Workplace Ordinance (ArbStättV) and the Regulation on Occupational Health Care (ArbMedVV), to a proper eye examination. If special visual aids (e.g., computer workstation glasses) are required, the employer must bear the costs.
Risk assessment and reimbursement
The necessity for special computer workstation glasses must be assessed by a risk assessment. If a medical certificate is available, there is an entitlement to reimbursement for the work-specific visual aid.
Traffic law significance
Obligation to wear glasses when driving a vehicle
Under the Driving License Regulation (FeV), during the medical-psychological assessment (MPU) or driving license test, it is checked whether a motor vehicle driver depends on glasses. If so, the driving license will include the annotation ‘visual aid required’ (formerly key number 01).
Sanctions for non-compliance
Failure to wear prescribed glasses when driving a vehicle constitutes a regulatory offense and may result in a fine and points in Flensburg. In the event of damage, contributory negligence or even gross negligence may be assumed, potentially leading to recourse claims by the insurer.
Product liability and warranty
Liability under the Product Liability Act (ProdHaftG)
As medical devices, glasses are also subject to the Product Liability Act. Manufacturers are liable for damages caused by defective glasses. The requirement is that a product defect is present (design, manufacturing, or instruction defect).
Warranty law claims
Buyer protection under Sections 434 et seq. of the German Civil Code (BGB) stipulates that in the event of defects in glasses (e.g., faulty grinding, stress cracks, incorrect adjustment), the buyer may demand repair, replacement, or rescission.
Reversal of burden of proof
Within the statutory warranty period of two years from delivery of the glasses, the entrepreneur bears the burden of proof during the first twelve months that no defect already existed at the time of delivery.
Data protection implications for visual aids
Protection of particularly sensitive data
The adjustment of glasses requires the processing of particularly sensitive health data under Art. 9 GDPR. Opticians are therefore subject to increased requirements for data security and the consent of the data subject.
Special aspects of protective and sports glasses
Occupational and accident protection
Protective glasses are subject to the regulations of occupational health and accident prevention (including DGUV Regulation 1). In many occupational sectors, employers are obliged to provide suitable protective glasses.
Standard-compliant execution
There is an obligation to use only tested and standard-compliant protective glasses (e.g., according to DIN EN 166), whose suitability and protective effect are demonstrable.
Other legal aspects
Tax deductibility
Under tax law, glasses are generally considered a cost of personal living expenses and are therefore not tax-deductible as business expenses. An exception exists for computer workstation glasses for which the employer pays.
Contract law specifics
The purchase of glasses generally constitutes a contract for work and services, particularly when customized adjustment takes place (Sections 631 et seq. BGB). This gives rise to special duties of protection, disclosure, and advice for the optician.
Summary
Glasses are not only everyday objects but are comprehensively regulated by law. Their legal treatment covers medical device law, social and occupational safety, product liability, and data protection. When providing glasses, a multitude of specific regulations must be observed to meet the needs of eligible persons, patients, and consumers.
Frequently Asked Questions
Who bears the costs for glasses under statutory health insurance?
The cost coverage for glasses is governed by the provisions of the Social Code (SGB V) and the relevant guidelines for medical aids and appliances. As a rule, statutory health insurance funds only provide allowances for lenses under certain circumstances, not for the frame. Eligibility generally applies to children and adolescents up to the age of 18 and adults with severe visual impairment, which must be confirmed by a medical prescription. The reimbursement amount is based on the so-called fixed amounts set for various types of lenses and diopter strengths. In addition, the glasses must be obtained from an authorized service provider (such as an optician with insurance approval). Privately incurred extra costs, for example for particularly thin or special lenses, glasses insurance or designer frames, are generally not reimbursed. Legal requirements also stipulate that an ophthalmologist’s prescription must be obtained prior to purchasing glasses to establish medical necessity.
Are there employment law requirements for employers to provide computer workstation glasses?
According to Section 3 (3) of the Workplace Ordinance (ArbStättV) and the Regulation on Occupational Health Care (ArbMedVV), the employer has a duty of care to employees under Section 3 ArbSchG. Accordingly, the employer must determine, as part of the risk assessment, whether and to what extent employees require special computer workstation glasses in order to perform their duties. If the company doctor determines, following a medical examination, that standard glasses are insufficient at a display screen workplace and a special visual aid is therefore necessary, the employer must bear the costs for these special glasses to the required extent. Costs for ‘normal’ corrective glasses or additional comfort features are not covered.
Under which conditions may eyeglass frames be deducted as business expenses for tax purposes?
The tax recognition of expenses for glasses as business expenses is generally excluded, as from the perspective of the tax authorities, these are typical personal living expenses (Section 12 No. 1 EStG). Exceptionally, however, glasses may be deducted as business or professional expenses if they are required exclusively for occupational purposes, such as special protective or work glasses (for example, welding or computer workstation glasses, provided these are used exclusively for work and not privately). Exclusively professional use must be proven by the taxpayer, for example by a certificate from the employer or company physician. Reimbursement as an extraordinary burden under Section 33 EStG is also only considered in exceptional cases, such as medical necessity and demonstrable rejection of cost coverage by the health insurance fund.
What legal requirements apply to the labeling and quality of glasses?
Glasses are considered medical devices according to the Medical Devices Act (MPG) or Medical Devices Implementation Act (MPDG) in conjunction with the European Medical Device Regulation (MDR). Manufacturers and distributors are required to affix the CE mark to spectacle lenses and frames, confirming compliance with fundamental requirements for safety and performance. Additionally, special requirements for material compatibility, optical quality, accuracy of correction values, and product safety apply to glasses. Professional businesses such as opticians must provide optical consultation and final inspection of the visual aid before handing over glasses. Legal infringements, such as missing CE marks, the use of unsafe materials, or faulty manufacture, can have civil and criminal consequences, such as warranty claims or fines.
What are the legal conditions for online ordering and returns of glasses?
When buying glasses online, consumers are generally entitled to the right of withdrawal under Section 355 of the German Civil Code (BGB) or the provisions of the Distance Selling Act (Sections 312g, 355 BGB). However, individually made glasses (prescription glasses with individual values) are usually excluded from the right of withdrawal (Section 312g (2) No. 1 BGB) as they are made to customer specifications and not suitable for return. Ready-made glasses (‘off-the-shelf reading glasses’), on the other hand, may be returned within 14 days without giving reasons. In case of doubt, the seller must transparently indicate which products are customized and may be excluded from the right of return. In addition, the provider is liable for defects in the context of statutory warranty.
What special protection rights apply for minor glasses wearers?
Minors are granted special protection in connection with the supply of glasses under child and youth welfare law as well as the Social Code. Unlike for adults, statutory health insurance usually covers the full costs of lenses for children and adolescents with medical indication, or within the scope of prescribed fixed amounts. Since children and adolescents are constantly growing and frequent adjustments of glasses may be necessary, entitlement to cost coverage can be asserted more frequently. In addition, there are special trade regulations on product safety and advertising restrictions, especially regarding the promotion of contact lenses and similar products to minors.
How is liability regulated if incorrectly manufactured glasses lead to health problems?
In the case of defective production of glasses, such as incorrectly ground lenses or incorrect vision strengths, the buyer’s civil law warranty claims under Section 437 BGB apply (subsequent performance, rescission, reduction, compensation for damages). The buyer must generally give the optician the opportunity to remedy the defect. If faulty glasses result in health damage, there are also claims under tort law (Section 823 BGB) for compensation for the damage incurred. If it is proven that the defect is due to gross negligence or intent, claims for damages for pain and suffering may also be asserted. Providers of medical devices (manufacturers as well as opticians) are also subject to the Product Liability Act (ProdHaftG), which provides for liability without fault in the case of defective products. An injured party must simply prove that the product was defective and that this caused the damage.
