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January 22, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 §2(2): Definition of Medical Device and Scope of Regulation
Slovakia Decree No. 158/2015 §2(2): Definition of Medical Device and Scope of Regulation
1. Legal Text and Core Definition
Paragraph 2(2) of Decree No. 158/2015 Z.z. defines a medical device as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- Control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
2. Key Criteria for Classification as Medical Device
To qualify as a medical device, all of the following must apply:
- Specific intended medical purpose (one or more of the listed indications)
- Principal mode of action is physical/mechanical (not primarily pharmacological/immunological/metabolic)
- Intended for human use (in vitro diagnostic devices are separately defined in §2(3))
- Manufacturer places it on the market under his own name
Accessories to medical devices are also regulated as medical devices. Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
3. Explicit Exclusions from Medical Device Scope
The definition explicitly excludes:
- Medicinal products (defined under separate pharmaceutical law)
- Cosmetics (regulated under cosmetic legislation)
- Human blood and blood products
- Human organs/tissues for transplantation
- Foodstuffs and food supplements
- Equipment for disinfection/sterilisation of medical devices (unless specifically intended for disinfection of MDD devices)
Source: Decree No. 158/2015 Z.z. §2(2) exclusions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
4. Borderline Products and Qualification Guidance
For borderline cases (e.g., software, combination products, substances):
- Primary intended purpose determines classification
- If pharmacological action is principal → medicinal product
- If physical/mechanical action is principal → medical device (even if assisted by pharmacological means)
- ŠÚKL and/or European Commission borderline decisions may apply
Source: Decree No. 158/2015 Z.z. §2(2) in context of EU borderline guidance (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
5. MDR Transition and Legacy Devices
During MDR transitional period (Regulation (EU) 2017/745 Article 120), legacy devices continue to use the MDD-derived definition in §2(2) until certificate expiry. New devices follow MDR Article 2(1) definition, which is substantially aligned but includes explicit software as medical device and refined in vitro diagnostic scope. Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
6. Practical Implications for RA Managers
- Verify intended purpose claims against §2(2) wording to avoid misclassification
- Document principal mode of action rationale in technical file
- For combination products, prepare justification showing non-pharmacological principal action
- Check against Slovak exclusions list before market placement
- Prepare for potential ŠÚKL query on borderline status
- Align legacy labelling/intended use with §2(2) definition
Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
7. Common Qualification Challenges
- Software/apps with monitoring/diagnostic claims
- Products with both mechanical and pharmacological effects
- Borderline between medical device and IVD
- Disinfectants claiming medical device disinfection
- Wearables with health monitoring functions
Source: Decree No. 158/2015 Z.z. §2(2) practical application (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
8. RA Checklist for Device Qualification
- Does the product have a specific medical purpose per §2(2)?
- Is the principal intended action non-pharmacological/immunological/metabolic?
- Is it intended by the manufacturer for human use?
- Are any exclusions under §2(2) applicable?
- Is accessory status or combination product justification documented?
- Does labelling/intended use align with the legal definition?
- Ready for potential ŠÚKL or EU borderline consultation?
Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
9. Consequences of Misclassification
Incorrect qualification may lead to:
- Invalid conformity assessment
- Administrative fines or product withdrawal
- Delayed market access
- Liability in case of adverse events
Source: Decree No. 158/2015 Z.z. enforcement context (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
10. Alignment with MDR Definition
While §2(2) reflects MDD Article 1(2)(a), MDR Article 2(1) introduces:
- Explicit inclusion of software
- Refined software qualification criteria
- Stronger emphasis on prediction/prevention claims
Manufacturers should prepare for full MDR alignment post-transition. Source: Decree No. 158/2015 Z.z. §2(2) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#paragraf-2.odsek-2)
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