Medical Devices and Other Technical Regulations: When MDR/IVDR Alone Is Not Enough

1. Multi-level regulation

By definition, a medical device must comply with the technical regulations in the field of medical devices (in Ukraine: TRs No. 753, 754, 755; in the EU: MDR/IVDR). However, in many cases, this is not the end of the story. Depending on the design and function, a device may also fall under other technical regulations:

• Pressure equipment.
  
  Ukraine has a Technical Regulation approved by Resolution of the Cabinet of Ministers No. 27 of January 16, 2019 (effective from January 23, 2020). It covers equipment operating at pressures above 0.5 bar and requires conformity assessment.
  
  Typical examples include:

  • gas cylinders and reservoirs,

  • oxygen generators,

  • vacuum stations and systems,

  • sterilizers and autoclaves,

  • cryogenic containers for storage of samples and biomaterials.

• Electrical safety (Low Voltage Directive, LVD).
  
  Requirements for the safe operation of electrical installations and low-voltage equipment exist and may apply to medical devices, although Ukraine does not yet have a separate “pure” LVD technical regulation equivalent to the EU. In practice, electrical safety is checked by the same conformity assessment body that certifies medical devices.

• Electromagnetic compatibility (EMC).
  
  Requirements for EMC also apply, especially to devices with wireless interfaces. Ukraine has not yet introduced a full analogue of the EU EMC Directive, but these aspects are assessed during the general conformity assessment, usually by the same body.

• Sources of ionizing radiation (X-ray, CT).
  
  For medical X-ray units, CT scanners and other devices generating ionizing radiation, additional oversight by the State Nuclear Regulatory Inspectorate of Ukraine (SNRIU) is mandatory:

  • License for the use of ionizing radiation sources (application + review within 60 days).

  • Compliance with the General Safety Rules for the Use of Ionizing Radiation Sources in Medicine (2017).

  • Non-isotope installations (including X-ray systems) are subject to entry in the State Register if not exempt from regulatory control.

  • SNRIU has the authority to restrict or suspend operation in case of violations.
    
    In practice: the manufacturer/importer passes medical conformity assessment, while the healthcare facility (user) must obtain a separate SNRIU license for operation.

• Machinery Directive.
  
  In the EU, the Machinery Directive applies to medical devices with moving parts (e.g. robotic surgical systems). Ukraine has no full analogue yet, but such requirements may also be considered during assessments.

• General product safety.
  
  If a device has additional functions beyond its medical purpose, broader product safety regulations may also apply.

2. Borderline classification: medical device or medicinal product?

Another complex situation arises when a medical device contains a medicinal substance:

• If the device achieves its principal intended action through pharmacological, immunological or metabolic means, it is no longer a device but a medicinal product.

• If the medicinal component is only auxiliary (e.g. an implant coated with an antibiotic to prevent infection), it remains a medical device, but with additional requirements.

In the EU, MDR directly regulates such cases (Annex VIII, Rule 14). They require assessment as a medical device plus consultation with the competent medicinal authority (EMA). In Ukraine, similar rules are implemented via the Ministry of Health and the State Expert Center.

3. Practical examples

• Infusion pumps: must comply not only with MDR but also with LVD and EMC.

• Medical sterilizers: fall under MDR, but may also be assessed under Machinery requirements.

• Drug-eluting implants: medical devices of Class III that require additional consultation with the medicinal authority.

• Cryogenic containers for storage of cells/tissues: may fall under the Pressure Equipment Regulation.

• X-ray units: certified as medical devices but also require a SNRIU license for use of ionizing radiation.

4. Implications for manufacturers

• More complex documentation: technical files must prove compliance not only with MDR/IVDR but also with electrical safety, pressure, radiation safety, etc.

• More authorities involved: in borderline cases, conformity assessment bodies, medicinal regulators, and even nuclear regulators may all be part of the process.

• Higher costs and longer timelines: additional tests, audits and consultations.

• Legal certainty: borderline decisions (device vs medicinal product) often require discussions with regulators at the planning stage.

5. Conclusion

Today, very few medical devices are limited to MDR/IVDR alone. Manufacturers must think broadly: “Does my device fall only under medical regulations, or also under others?”. In cases involving medicinal or radiation components, early identification of the main mechanism of action and additional regulatory requirements is critical to avoid costly delays.