RoHS Category 8: Medical Devices

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What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. 

The ten hazardous materials included in RoHS must be used in electronics only below specific thresholds. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

  • Cadmium (Cd)
  • Mercury (Hg)
  • Lead (Pb)
  • Hexavalent Chromium (Cr VI)
  • Polybrominated Biphenyls (PBB)
  • Polybrominated Diphenyl Ethers (PBDE)
  • Bis(2-Ethylhexyl) phthalate (DEHP)
  • Benzyl butyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

Which Products Does RoHS Restrict?

It is important that manufacturers determine whether their product fits the definition of EEE, because all EEE, including smaller components, is subject to RoHS compliance requirements. RoHS defines EEE as: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). 

RoHS breaks down restricted EEE into 11 categories. The current categories are the result of one original directive and two additions known as RoHS 2 and 3. Read more: The Difference Between RoHS 1, 2 and 3

The current categories are:

  • Category 1: Large household appliances (eg. refrigerators)
  • Category 2: Small household appliances (eg. hair dryers)
  • Category 3: Computing & communications equipment (eg. computers)
  • Category 4: Consumer electronics  (eg. televisions)
  • Category 5: Lighting (eg. lamps)
  • Category 6: Power tools (eg. electric drills)
  • Category 7: Toys, leisure and sports equipment (eg. electronic dolls)
  • Category 8: Medical devices and equipment, such as in-vitro diagnostic devices, known as IVDs
  • Category 9: Monitoring and control instruments, such as thermostats and smoke detectors
  • Category 10: Automatic dispensers (eg. vending machines)
  • Category 11: Any EEE not covered in the previous ten categories. This includes EEE products such as two-wheeled electric vehicles, e-cigarettes and vapes, and electrical cables of less than 250 volts.

Categories 8 and 9 were added by RoHS 2 (Directive 2011/65/EU), and Category 11 was added by RoHS 3 (Directive EU 2015/863). The other categories were included in the original RoHS directive. As of July 22, 2021 all EEE under every category must comply with RoHS.

What Is Included in Category 8?

Category 8 includes all EEE that falls under the definition of medical devices and equipment. Also included are in-vitro diagnostic devices (IVDs), which are devices used to test human biological samples like blood or tissue. Note that RoHS does not apply to all medical devices, only electronic and electrical medical devices and equipment.

Medical devices that are within the scope of RoHS include, but are not limited to:

  • Blood pressure meters
  • Blood analyzers (eg. to measure cholesterol or blood sugar) (IVD)
  • Electrical self-test kits (IVD)
  • Respiration monitors
  • Immunoassay analyzers (IVD)
  • Endoscope
  • Ultrasound
  • CT scanner
  • PET (Positron Emission Tomography)
  • X-ray imaging
  • Medical thermometer
  • Dialysis equipment
  • Medical freezers
  • Gamma camera
  • Intravenous drug infusion pumps
  • Ventilators
  • External defibrillators and pacemakers (not implanted)
  • Hearing aids
  • Surgical microscope
  • Electrical hospital beds
  • Electrical surgical tools
  • Medical lasers
  • ECG
  • Electrical anaesthesia equipment
  • Electrical operating theater equipment
  • Electrical dental equipment

This list is not exhaustive, and manufacturers must assess their EEE on a case by case basis to determine if it is within the scope of products regulated by RoHS.

Exemptions

RoHS includes some general exemptions that may apply to medical equipment. There are also several exemptions that are specific to medical equipment.

Active Implantable Medical Devices

Any active implantable medical devices (AIMDs) are not subject to RoHS regulation. AIMDs are devices that are implanted in the human body, intended to remain in place after the procedure, and dependent on an energy source outside the human body to function.

Active Implantable Medical Devices include, but are not limited to:

  • Cardiac pacemakers
  • Neurostimulator systems
  • Brachytherapy systems
  • Cochlear implants
  • Glucose monitors
  • Defibrillators
  • Leads, electrodes, and adaptors for pulse generators
  • Ventricular Assist Devices
  • Infusion pumps
  • Micro Electro-Mechanical Systems (MEMS)

Further information on the definition of AIMDs can be found in EU Regulation 2017/745.

Read more about RoHS exemptions: What is RoHS Compliant?

Medical Devices that Fall under Other RoHS Exemption Categories

RoHS includes categories of EEE that are exempt from regulation. Medical devices that fall under the following exempted categories are also exempt.

  • Equipment necessary for security, including arms, munitions and material intended for military purposes
  • Equipment designed to be sent into space
  • Large -scale stationary industrial tools
  • Large-scale fixed installations
  • Means of transport for people or goods
  • Non-road mobile machinery exclusively for professional use
  • Active implantable medical devices
  • Permanently installed photovoltaic panels to produce solar energy
  • Equipment designed for business-business research
  • Equipment that is designed to be installed in another type of equipment that is excluded under RoHS.

Examples that may be considered exempt under one of the above categories include electric scooters used by disabled persons, as these may be considered a form of transport. Another example is a proton therapy facility that includes a particle accelerator, as this may be considered a large-scale fixed installation. 

It is important that manufacturers are certain that their non-compliant product is included under one of the exempt categories, as placing a non-exempt, non-RoHS compliant product on the market can result in penalties. Read more: RoHS Noncompliance Penalties

Hazardous Substance Exemptions for Specific Types of Medical Devices

RoHS also includes more focused exemptions for hazardous substances that may only be used in specific applications, such as in specific medical devices. For example, while lead is restricted above 1000ppm in all EEE, it is allowed to be used above this level as lead bearings in X-ray tubes.

A full list of substances exempt from restrictions when used in specific medical applications can be found in Annex IV of RoHS 2 (Directive 2011/65/EU).

The directive pushes companies to search for alternative substances and processes that are RoHS compliant, even while using the original, exempted material. If a viable alternative is not found, extension of the exemption is possible.

To encourage innovation, these specific exemptions are temporary and expire on a set date. Manufacturers must remain aware of exemption expiration dates so as not to continue use of a material or application that is no longer exempt.

Medical Devices with No Safe Substitutions

In order to be RoHS compliant, medical devices must use substitutes for restricted hazardous materials. However, these substitutions must be deemed safe before the medical device can be placed on the market. If substitutions are deemed unsafe, then the manufacturer can apply for an exemption. If the exemption is granted, the manufacturer can continue using substances restricted by RoHS above allowable limits.

While manufacturers can apply for exemptions for any substance for which there is no safe alternative, medical devices are mentioned specifically in the directive, as they must undergo a more extensive review process.

RoHS states that placing a medical device on the market requires a conformity assessment procedure according to several other EU directives concerning medical devices (Council Directive 93/42/EEC and Directive 98/79/EC). Through this process, a notified body (an official conformity assessment organization) must certify that the potential substitute for a hazardous substance also has negative socioeconomic, health, and consumer safety impacts. The manufacturer can then apply for an exemption for that medical device. (Note: The notified body is appointed by the Member State, and varies across countries.)

These exemptions are also subject to expiration dates, so manufacturers must remain aware of changing exemptions.

Impact of RoHS Category 8

RoHS may have several impacts on medical devices included in category 8.

Increased Price of Production

RoHS restrictions on medical devices may increase prices for medical devices, as manufacturers must take steps to ensure RoHS compliance. Electrical medical device manufacturers must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing electrical medical devices and ensuring RoHS compliance may be costly.

Increased Scientific & Technological Innovation

However, increased costs come hand in hand with increased innovation. RoHS pushes scientific and technological progress in the medical field forward, as medical devices and production processes are redesigned to exclude restricted substances.

Shifting Technologies for Patients

Lastly, RoHS may impact hospitals, doctors, and patients who rely on electronic medical devices. Costs may increase initially as a result of increased manufacturing and compliance costs. Additionally, the use of new devices or technologies may be required if manufacturers create new solutions to comply with RoHS.

However, RoHS will not make it difficult for patients to get necessary medical devices. The RoHS exemption rules described above were created to ensure that if no safe substitutions are available, no one goes without a necessary device, even if it uses higher than allowed restricted substances.

Read more about the impact of RoHS: What is RoHS?