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January 22, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 1: Classification Rules for Medical Devices
Slovakia Decree No. 158/2015 Annex 1: Classification Rules for Medical Devices
1. Legal Basis and Purpose
Annex 1 (Príloha č. 1) to Decree of the Ministry of Health of the Slovak Republic No. 158/2015 Z.z. on technical requirements and procedures for conformity assessment of medical devices details the classification rules. It transposes Annex IX of Council Directive 93/42/EEC (MDD) into Slovak law and remains applicable during the MDR transitional period for legacy devices. The rules determine the risk-based class (I, IIa, IIb, III) to guide conformity assessment route and regulatory controls. Source: Decree No. 158/2015 Z.z. Annex 1 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
2. General Principles of Classification
Classification is based on:
- Intended purpose of the manufacturer
- Duration of contact with the body (transient <60 min, short-term ≤30 days, long-term >30 days)
- Degree of invasiveness
- Active or non-active nature
- Incorporation of medicinal substances, biological origin materials, or absorption by the body
Rules are applied cumulatively; the highest applicable rule determines the class. Source: Decree No. 158/2015 Z.z. Annex 1, Introductory provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
3. Non-Invasive Devices (Rules 1–4)
- Rule 1: Non-invasive devices for storage, channeling, or mechanical treatment of body liquids/tissues → Class I (unless blood storage → IIa).
- Rule 2: Devices for channeling blood, storing blood/organs → IIa/IIb depending on risk.
- Rule 3: Devices modifying biological/chemical composition of blood/liquids → IIb.
- Rule 4: Non-invasive devices in contact with injured skin → I/IIa/IIb depending on depth/healing role.
Source: Decree No. 158/2015 Z.z. Annex 1, Rules 1–4 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
4. Invasive Devices (Rules 5–8)
- Rule 5: Invasive devices for short-term use (e.g., surgical instruments) → I/IIa.
- Rule 6: Invasive devices for long-term use (e.g., implants) → IIb/III.
- Rule 7: All implantable/invasive surgical devices → IIb (unless direct heart/circulation contact → III).
- Rule 8: Devices modifying composition of blood → III.
Source: Decree No. 158/2015 Z.z. Annex 1, Rules 5–8 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
5. Active Devices (Rules 9–12)
- Rule 9: Active therapeutic devices delivering energy → IIa/IIb (high risk → III).
- Rule 10: Active diagnostic devices → I/IIa/IIb (radiation-emitting → IIb).
- Rule 11: Active devices for direct drug administration → IIa/IIb/III.
- Rule 12: All other active devices → Class I.
Source: Decree No. 158/2015 Z.z. Annex 1, Rules 9–12 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
6. Special Rules (Rules 13–18)
- Rule 13: Devices incorporating medicinal substances → III.
- Rule 14: Devices incorporating biological tissues → III.
- Rule 15: Devices for sterilization/disinfection → IIa/IIb.
- Rule 16: Devices for recording X-ray diagnostic images → IIa.
- Rule 17: Software → Class according to intended purpose (often I/IIa).
- Rule 18: Devices intended for contraception or prevention of sexually transmitted diseases → IIb/III.
Source: Decree No. 158/2015 Z.z. Annex 1, Rules 13–18 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
7. Transitional Application under MDR
For legacy devices under MDD, these rules continue to apply during the transitional period per MDR Article 120. New devices follow MDR classification rules (Annex VIII). Manufacturers should verify if legacy classification remains valid or requires re-classification. Source: Decree No. 158/2015 Z.z. Annex 1 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
8. Practical Guidance for RA Managers
- Map intended use against the 18 rules sequentially.
- Document rule application and justification in technical file.
- For borderline/software/combination products, apply multiple rules and take the highest class.
- Prepare for potential re-classification when transitioning to full MDR.
- Consult ŠÚKL guidance or seek opinion for ambiguous cases.
Source: Decree No. 158/2015 Z.z. Annex 1 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
9. Common Classification Examples
- Surgical gloves → Rule 1 → Class I
- Surgical drapes → Rule 1 → Class I
- Hip implant → Rule 8 → Class III
- Infusion pump → Rule 11 → Class IIb
- Diagnostic ultrasound → Rule 10 → Class IIa
- Condom → Rule 18 → Class IIb
Source: Decree No. 158/2015 Z.z. Annex 1 application examples (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
10. Risks of Incorrect Classification
Misclassification can lead to:
- Inappropriate conformity assessment (e.g., self-certification instead of notified body).
- Regulatory action by ŠÚKL (withdrawal, fines).
- Delayed market access or product recall.
Always document classification rationale thoroughly. Source: Decree No. 158/2015 Z.z. Annex 1 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_1_k_vyhlaske_c_158_2015_z_z.oznacenie)
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