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January 25, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §46(4): Authorized Representative Record-Keeping and Documentation Duties
Slovakia Act No. 362/2011 §46(4): Authorized Representative Record-Keeping and Documentation Duties
1. Legal Provision Text
Paragraph 46(4) states that the authorized representative shall keep and make available to the competent authority all documentation and records relating to the medical devices for which he acts as the authorized representative, in accordance with the special regulation. Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
2. Scope of Documentation Obligations
The AR must maintain:
- Copies of technical documentation (or access rights)
- EU declarations of conformity
- Vigilance and PMS records
- Correspondence with manufacturer and authorities
- Registration documents and updates
- Any certificates or audit reports
Records must be complete, current, and readily available upon request. Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
3. Retention Periods and Accessibility
- Keep documentation for at least 5 years after the last device is placed on the market (or 15 years for implantable devices)
- Ensure records are stored securely and protected from loss/damage
- Make available immediately to ŠÚKL upon request
- Provide in Slovak or English as required
Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
4. MDR Transition Considerations
For legacy devices under MDD transitional provisions (MDR Article 120):
- §46(4) record-keeping continues until MDD certificate expiry
- After transition, MDR Article 11(3) and Article 10(8) require enhanced documentation access and retention (typically 10–15 years)
- ARs must align retention policies with MDR and ensure EUDAMED compatibility
Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
5. Practical RA Guidance for ARs
- Establish secure digital repository for manufacturer documents
- Implement document control with version tracking and expiry alerts
- Maintain central log of all ŠÚKL requests and responses
- Conduct periodic internal audits of record completeness
- Include record-keeping clauses in AR-manufacturer agreements
- Train staff on confidentiality and rapid retrieval protocols
Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
6. Common Record-Keeping Challenges
- Limited or delayed access to manufacturer technical files
- Incomplete vigilance/PMS documentation from manufacturer
- Language barriers in original documents
- Storage of large volumes of paper/digital records
- Ensuring long-term retention after manufacturer changes
Source: Act No. 362/2011 Coll. §46(4) practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
7. RA Documentation Checklist
- Do you have current technical documentation copies/access?
- Are DoCs complete, signed, and device-specific?
- Are vigilance/PMS records up-to-date and archived?
- Is there a documented retention policy (5–15 years)?
- Are records secure, backed up, and access-controlled?
- Can all documents be provided to ŠÚKL within hours?
Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
8. Enforcement and Non-Compliance Risks
Failure to maintain/ provide records may result in:
- Administrative fines
- Order to cease representing the manufacturer
- Market surveillance actions against devices
- Potential impact on AR registration status
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
9. Alignment with MDR Documentation Requirements
While §46(4) reflects MDD record-keeping, MDR Article 10(8) and Article 11(3) strengthen to:
- Explicit right of access to technical documentation
- Longer retention periods (10–15 years)
- Integration with EUDAMED data
- Requirement for person responsible for regulatory compliance
ARs should enhance documentation systems for MDR readiness. Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
10. Best Practices for Robust Record Management
- Use cloud-based secure document management system
- Implement automated retention reminders and deletion protocols
- Conduct annual mock ŠÚKL request exercises
- Maintain bilingual index of all records
- Include record-keeping in AR quality manual
Source: Act No. 362/2011 Coll. §46(4) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-46.odsek-4)
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