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January 25, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §124b(6): Joint Liability of Authorized Representative for Defective Medical Devices
Slovakia Act No. 362/2011 §124b(6): Joint Liability of Authorized Representative for Defective Medical Devices
1. Core Legal Text
Paragraph 124b(6) provides: The authorized representative shall be jointly and severally liable with the manufacturer for damage caused by a medical device that is defective within the meaning of the special regulation on liability for damage caused by a defective product, if the manufacturer is not established in a Member State of the European Union. Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
2. Trigger Conditions for Liability
Joint liability arises when all are met:
- Medical device placed on Slovak market by non-EU manufacturer
- Device qualifies as defective under Product Liability Act (transposing Directive 85/374/EEC)
- Damage (death, personal injury, property damage > threshold) occurs
- Authorized representative is established in Slovakia
Defect defined as lack of safety reasonably expected, considering presentation, use, marketing time. Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
3. Nature of Joint and Several Liability
- Injured person can claim full compensation from AR alone, manufacturer alone, or both
- AR pays, then seeks recourse from manufacturer
- Strict liability — no need to prove fault/negligence
- Does not limit manufacturer’s primary liability
Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
4. Covered Damages
Liability covers:
- Death or personal injury
- Damage to property (private use, above statutory threshold)
- Economic loss directly linked to personal injury/property damage
Moral/non-pecuniary damages may be claimed under general civil rules. Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
5. MDR Transition Impact
Legacy devices under MDD transitional period (MDR Article 120):
- §124b(6) joint liability applies until MDD certificate expiry
- Post-transition, MDR Article 10(16) continues equivalent AR joint liability for non-EU manufacturers
- Exposure persists for devices placed before full MDR application
Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
6. RA Manager Practical Considerations
- Secure product liability insurance specifically covering AR exposure
- Negotiate comprehensive indemnity and hold-harmless clauses in AR agreement
- Maintain detailed conformity, risk management, and PMS records as defense
- Implement rapid incident investigation to mitigate defect claims
- Monitor ŠÚKL vigilance reports for early defect signals
- Establish claim notification cascade to insurer/legal counsel/manufacturer
Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
7. Typical Claim Triggers
- Patient injury from alleged inadequate labelling/instructions
- Device malfunction leading to serious adverse event
- Widespread defects prompting class/collective claims
- Recall situations where causation linked to design/manufacturing
- Claims exceeding manufacturer’s insurance or solvency
Source: Act No. 362/2011 Coll. §124b(6) practical application (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
8. RA Liability Mitigation Checklist
- AR agreement includes full recourse/indemnity from manufacturer?
- Product liability coverage limits sufficient for Slovak claims?
- Technical documentation complete, current, and AR-accessible?
- Vigilance/PMS integrated with liability risk monitoring?
- Slovak-specific IFU/warnings reviewed for adequacy?
- Claim intake/escalation protocol documented?
- Historical claims/patterns tracked and analyzed?
Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
9. Claim Procedure in Slovakia
- Claims governed by Product Liability Act and Civil Code
- Filed in Slovak courts (usually claimant’s residence)
- ŠÚKL may provide vigilance/market surveillance evidence
- Limitation: 3 years from awareness of damage, max 10 years from placement
- Courts may apportion if multiple liable parties
Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
10. Alignment with MDR Liability Rules
§124b(6) mirrors MDD-era joint liability; MDR Article 10(16) retains:
- Joint and several liability for non-EU manufacturers via AR
- Strict liability standard
- Consistency with EU Product Liability Directive
ARs should maintain robust risk transfer and insurance strategies. Source: Act No. 362/2011 Coll. §124b(6) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124b.odsek-6)
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