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January 5, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 2: List of Classified Medical Devices and Examples
Slovakia Decree No. 158/2015 Annex 2: List of Classified Medical Devices and Examples
1. Legal Basis and Purpose
Annex 2 (Príloha č. 2) to Decree of the Ministry of Health No. 158/2015 Z.z. contains an indicative (non-binding) list of medical devices grouped by type with their corresponding risk classification according to the rules set out in Annex 1. It serves as a practical guidance tool to help manufacturers, notified bodies and the State Institute for Drug Control (ŠÚKL) apply the classification rules consistently. The list is illustrative and does not replace case-by-case assessment based on intended purpose. Source: Decree No. 158/2015 Z.z. Annex 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
2. Structure of the Annex
The annex is organised into broad categories reflecting the MDD classification structure:
- Non-invasive devices
- Invasive devices
- Active devices
- Devices with special features (e.g., incorporating medicinal substances, biological tissues, software, radiation-emitting)
Each entry provides a device description and the assigned class (I, IIa, IIb, III). Source: Decree No. 158/2015 Z.z. Annex 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
3. Selected Examples from Non-Invasive Devices
- Bandages, dressings for superficial wounds → Class I
- Devices for channeling or storing blood → Class IIa
- Devices for storing organs, blood bags → Class IIa
- Non-invasive devices for disinfection → Class IIa
- Devices for treatment of injured skin (primary healing) → Class IIb
Source: Decree No. 158/2015 Z.z. Annex 2, Non-invasive section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
4. Selected Examples from Invasive Devices
- Surgical instruments (reusable) → Class I
- Sutures, staples → Class IIa
- Dental implants → Class IIb
- Joint replacements (hip, knee) → Class III
- Heart valves → Class III
Source: Decree No. 158/2015 Z.z. Annex 2, Invasive section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
5. Selected Examples from Active Devices
- Active therapeutic devices (e.g., infusion pumps) → Class IIa/IIb
- Diagnostic ultrasound systems → Class IIa
- X-ray equipment → Class IIb
- Active devices for direct drug administration (e.g., insulin pumps) → Class IIb
- Active implants (e.g., pacemakers) → Class III
Source: Decree No. 158/2015 Z.z. Annex 2, Active devices section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
6. Special Cases and Combination Devices
- Devices incorporating medicinal substances (e.g., drug-eluting stents) → Class III
- Devices incorporating viable biological tissues → Class III
- Software for diagnosis/therapy → Class according to intended purpose (often IIa/IIb)
- Condoms and contraceptive devices → Class IIb
- Devices for sterilisation of other devices → Class IIa
Source: Decree No. 158/2015 Z.z. Annex 2, Special rules section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
7. Practical Use During MDD/MDR Transition
For legacy devices under MDD transitional provisions (MDR Art. 120), this annex remains a key reference for classification in Slovakia. New devices must follow MDR Annex VIII, but the examples can aid in understanding equivalent risk levels. Manufacturers should document any deviation from the list with justification. Source: Decree No. 158/2015 Z.z. Annex 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
8. RA Manager Checklist for Classification Reference
- Locate the closest matching device description in the annex.
- Verify the assigned class against the specific intended use.
- Cross-check with Annex 1 rules if the device has unique features.
- Document the reference to Annex 2 in the technical file.
- Consult ŠÚKL or a notified body if the device does not fit listed examples.
- Prepare for potential class increase under full MDR application.
Source: Decree No. 158/2015 Z.z. Annex 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
9. Limitations of the List
The annex states it is non-exhaustive and illustrative only. Final classification must be determined by:
- Manufacturer's intended purpose
- Application of Annex 1 rules cumulatively
- Professional judgement and, if necessary, ŠÚKL opinion
Misreliance on the list without rule verification can lead to incorrect conformity assessment. Source: Decree No. 158/2015 Z.z. Annex 2 introductory note (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
10. Common Pitfalls and Recommendations
- Assuming listed class is binding → always apply rules.
- Overlooking combination features → check special rules 13–18.
- Using outdated list for MDR devices → verify against MDR examples.
- Recommendation: Maintain an internal classification matrix cross-referencing Annex 1 rules and Annex 2 examples for portfolio management.
Source: Decree No. 158/2015 Z.z. Annex 2 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_2_k_vyhlaske_c_158_2015_z_z.oznacenie)
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