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January 15, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §126(5): Distributor Obligations for Medical Device Compliance Verification
Slovakia Act No. 362/2011 §126(5): Distributor Obligations for Medical Device Compliance Verification
1. Legal Provision Text
Paragraph 126(5) requires distributors to verify, before distributing a medical device in the territory of the Slovak Republic, that the device is marked with the conformity mark, is accompanied by the required information and instructions for use in the Slovak language, and that the manufacturer or authorized representative has fulfilled the obligations under this Act. Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
2. Who Must Comply
This obligation applies to:
- Distributors of medical devices in Slovakia
- All classes of devices (I to III, including custom-made and IVDs where applicable)
- Entities placing devices on the market or putting them into service
Manufacturers and ARs have separate duties, but distributors act as a checkpoint. Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
3. Verification Requirements
Distributors must check:
- Presence of CE conformity marking
- Accompanying information, labelling, and IFU in Slovak language
- Manufacturer/AR compliance with Act obligations (e.g., registration, vigilance)
- Any other required documentation (e.g., DoC reference)
Verification should be documented and retained for audits. Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
4. MDR Transition Implications
For legacy devices under MDD transitional provisions (MDR Article 120):
- §126(5) verification continues until MDD certificate expiry
- After transition, MDR Article 16 imposes similar but enhanced distributor verification duties
- Distributors must prepare for MDR alignment, including EUDAMED checks
Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
5. Practical Guidance for RA Managers
- Develop SOP for incoming device verification
- Train distribution staff on CE mark, labelling checks
- Maintain records of verification for 5–15 years (device-dependent)
- Coordinate with manufacturers/ARs for compliance evidence
- Implement rejection protocol for non-compliant devices
- Integrate with QMS for ISO 13485 compliance
Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
6. Common Compliance Challenges
- Incomplete or incorrect Slovak translations
- Missing or expired conformity certificates
- Language barriers in verification
- Supply chain delays from verification
- Lack of distributor access to manufacturer docs
Source: Act No. 362/2011 Coll. §126(5) practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
7. RA Checklist for Distributor Verification
- Is CE mark present and valid?
- Are labels/IFU in Slovak and compliant?
- Has manufacturer/AR registration been confirmed?
- Is DoC available and matches device?
- Are PMS/vigilance obligations evidenced?
- Verification documented and archived?
Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
8. Enforcement and Non-Compliance Risks
Failure to verify may result in:
- Administrative fines
- Product seizure or recall
- Suspension of distribution activities
- Civil liability for defective devices
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
9. Alignment with MDR Distributor Duties
While §126(5) reflects MDD distributor verification, MDR Article 16 expands to:
- Explicit checks on importer/manufacturer compliance
- Verification of UDI and EUDAMED registration
- Stricter language and labelling requirements
- Ongoing monitoring obligations
Distributors should align Slovak duties with MDR expectations. Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
10. Best Practices for Compliance
- Automate verification with checklists/apps
- Conduct supplier audits annually
- Use bilingual staff for Slovak checks
- Integrate verification into ERP systems
- Share compliance templates with manufacturers
Source: Act No. 362/2011 Coll. §126(5) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-126.odsek-5)
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