Planning to import and sell prescription glasses, medical gloves, thermometres or other related medical products in the European Union? If so, chances are that you must ensure compliance with the Medical Devices Directive. In this guide, we list both exemptions and products covered by the scope of the Medical Devices Directive.
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Prescription Glasses
Prescription glasses are covered under the Medical Devices Directive, even if they are also intended for sunlight or UV protection. Also, they have been classified as Class I medical devices under the directive, which have the lowest perceived risk.
Further, prescription lenses such as optical lenses are also categorized as a medical device. With that said, you shall ensure that the lenses are compliant with the essential requirements of the directive.
EN standards:
- EN 166 – Personal eye protection standard
- EN 11978 – Labeling of contact lenses and contact lens care products
- EN 14534 – Basic requirements of contact lenses and contact lens care products
Examples
- Prescription Glasses with single vision lenses
- Prescription Glasses with transition lenses
- Prescription Glasses with bifocal and trifocal lenses
- Prescription Glasses with progressive lenses
- Prescription Glasses with computer lenses
Medical Masks
Medical masks such as surgical masks and respirators are fall into the scope of the Medical Devices Directive. Medical masks are used to protect against airborne particles to prevent contamination; therefore, they must meet the safety requirements under the directive.
Medical masks are classified as Class I medical devices under the directive. They shall comply with applicable EN standards including EN 149 and EN 14683. Also, the masks shall be tested for 3 levels of bacterial filtration efficiency (Type I, Type II, and Type IIR).
EN standards:
- EN 149 – Requirements for respiratory protective devices
- EN 14683 – Requirements and test methods for surgical masks
Examples
- N95 respirators
- N99 respirators
- N100 respirators
- Surgical masks
Medical Gloves
In the medical field, protective gloves are required to prevent direct skin contact with hazardous substances such as blood and germs. Therefore, they must be compliant with the Medical Devices Directive.
Medical gloves are usually used for low to medium risk. Depending on whether it is for transient use – that is used for less than 60 minutes – or short term use – that is used between 60 minutes and 30 days, – medical gloves can be categorized as Class I (transient use) and Class IIa (short term use) accordingly.
EN standards:
- EN 21171 – Medical gloves – Determination of removable surface powder
- EN 455 – Medical gloves – for single use requirements and testing
Examples
- Surgical gloves
- Examination gloves
Medical Thermometers
Medical thermometers are categorized as Class I medical measurement devices, which are intended to allow direct diagnosis of vital physiological processes. As such, you will need to comply with the Medical Devices Directive.
In addition, there is a harmonized standard, EN 12470, for clinical thermometers under the Medical Devices Directive, which covers the requirements of metallic liquid, phase change type, and performance of the thermometers.
EN standard:
- EN 12470 – Clinical thermometers Part 1 – 5
Examples
- Electronic ear thermometers
- Forehead thermometers
- Plastic strip thermometers
- Pacifier thermometer
- Glass and mercury thermometers
Stethoscopes
Most of the medical diagnosis devices such as stethoscopes are covered under the Medical Devices Directive. Moreover, stethoscopes are in Class I and considered non-invasive medical devices with low risk.
If your stethoscope is sterile or equipped with measuring functions, then you will need to perform a notified body assessment and register with the competent authority. If your stethoscope product is not a sterile or measuring device, then you will need to self-certificate your product before entering the EU market.
Examples
- Cardiology stethoscopes
- Infant stethoscopes
- Neonatal stethoscopes
- Pediatric stethoscopes
- Electronic stethoscopes
- Teaching stethoscopes
Syringes and Catheters
Syringes are usually considered as Class IIa surgically invasive devices, which are intended for transient use of medical treatment. On the other hand, catheters can be categorized in Class I, IIa, and IIb depends on transient, short-term, or long-term use.
Syringes and catheters are widely used in the medical field and must comply with the Medical Devices Directive.
EN standards
- EN 9997 – Dental cartridge syringes
- EN 8537 – Sterile single-use syringes for insulin
- EN 12439 – Sterile rectal catheters for single-use
Examples
- Insulin syringes
- Catheter tips syringes
- Luer slip syringes
- Luer lock syringes
- Indwelling catheters
- External catheters
- Short-term catheters
Wheelchairs
Wheelchairs are covered by the Medical Devices Directives and can only be marketed and sold in the EU if they are compliant. Wheelchairs are categorized in Class I medical devices, and importers or manufacturers can self-certificate the products with documents such as technical file and Declaration of Conformity (DoC).
The requirements can apply to other external patient support devices, such as hospital beds, walking aids and stretchers. Notice that other associated medical devices to wheelchairs should be treated separately, and according to their own classification.
EN standards
- EN 12183 – Manual wheelchairs – requirements and test methods
- EN 12184 – Electrically powered wheelchairs – requirements and test methods
- EN 12182 – Technical aids for disabled persons
Examples
- Manual wheelchairs
- Electric wheelchairs
- Reclining wheelchairs
- All-Terrain wheelchairs
- Ergonomic wheelchairs
Laser Devices
Lasers that use focused light resources for medical treatment are considered medical devices, as such, they must comply with the Medical Devices Directive. Further, surgical lasers are considered as invasive devices and categorized in Class IIb.
The Medical Devices Directive covers lasers that are used in many types of medical applications, such as cosmetic surgery, refractive eye surgery, and dental surgery. In addition, Class IIb devices must be reviewed by a notified body as required under the directive.
EN standards
- EN 11810 – Lasers and laser-related equipment – Test method and classification
- EN 11990 – Lasers and laser-related equipment – Laser resistance of tracheal tubes
- EN 60601 – Requirements for the safety of diagnostic and therapeutic lase equipment
Examples
- Diode lasers
- Gas lasers
- Solid-state lasers
- Dye lasers
Tattoo Removal Equipment
Tattoo removal equipment was not covered by the Medical Devices Directive before the year 2020. However, tattoo removal equipment is now under the scope of the Directive.
Tattoo removal equipment is considered as a non-invasive device, and the performance must be evaluated to ensure safety to the user. Notice that tattoo-related products are excluded from the new regulations, and it only concerns the devices itself.
Examples
- Laser treatments removal equipment
- Dermabrasion removal equipment
- Chemical peels removal equipment
Products Exempted from the Medical Devices Directive
Most devices used for medical purposes are regulated by the Medical Devices Directives. However, there are some exemptions:
- In vitro diagnostic devices
- Active implantable devices
Notice that such products may be covered by other directives. You shall consult a notified body In case you are unsure about the classification of your products.
