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January 15, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §124a(4)(d): Authorized Representative Obligations for Foreign Manufacturers
Slovakia Act No. 362/2011 §124a(4)(d): Authorized Representative Obligations for Foreign Manufacturers
1. Legal Provision Text
Paragraph 124a(4)(d) states that the authorized representative shall, upon reasoned request from the competent authority (ŠÚKL), provide or make available:
- the technical documentation
- the EU declaration of conformity
- where applicable, a copy of the relevant certificates
for medical devices placed on the market by a manufacturer not established in the European Union. Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
2. Who Must Comply
This obligation applies to:
- Authorized representatives established in Slovakia acting for non-EU manufacturers
- All classes of medical devices (I to III, including custom-made and sterile Class I)
- Devices placed on the Slovak market under the MDD-transposed regime
The manufacturer remains ultimately responsible, but the AR acts as the local point of contact. Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
3. Documents That Must Be Available
The authorized representative must keep ready:
- Complete technical documentation (design dossier, risk management file, clinical evaluation, PMS data, etc.)
- Signed EU declaration of conformity
- Relevant conformity assessment certificates (notified body issued)
- Any amendments or supplements to the above
These must be available in a form that allows prompt provision to ŠÚKL. Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
4. Request Process and Timeline
- ŠÚKL may request documents with a reasoned justification
- Authorized representative must provide or make available without undue delay
- Documents should be provided in Slovak or English (translations may be required for critical safety sections)
- Failure to comply promptly may lead to enforcement actions
Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
5. MDR Transition Considerations
For legacy devices under MDD transitional provisions (MDR Article 120):
- AR obligations under §124a(4)(d) continue until MDD certificate expiry
- After transition, MDR Article 11(3) imposes similar but more detailed AR responsibilities
- AR must prepare for full MDR alignment, including EUDAMED registration
Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
6. Practical Guidance for RA Managers
- Maintain up-to-date master file access agreement with non-EU manufacturer
- Keep electronic copies of all required documents readily accessible
- Establish 48–72 hour internal response protocol for ŠÚKL requests
- Prepare Slovak summaries or translations for key safety/performance sections
- Document all ŠÚKL requests and provision records for audit trail
- Coordinate with global RA to ensure consistency across EU ARs
Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
7. Common Compliance Challenges
- Incomplete technical documentation transferred from manufacturer
- Outdated or revoked certificates not promptly updated
- Language barriers delaying provision of Slovak versions
- Poor record-keeping of ŠÚKL request history
- Delays due to time zone differences with non-EU manufacturer
Source: Act No. 362/2011 Coll. §124a(4)(d) practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
8. RA Checklist for AR Readiness
- Do you have immediate access to full technical documentation?
- Is the current EU DoC signed and available?
- Are all relevant certificates (including supplements) current?
- Have you tested the document provision process internally?
- Are Slovak translations/summaries prepared for critical parts?
- Is the request response SOP documented and trained?
- Are records of previous ŠÚKL interactions archived?
Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
9. Enforcement and Non-Compliance Risks
Failure to provide requested documents may result in:
- Administrative fines
- Order to suspend marketing or withdraw product
- Revocation of authorization to act as AR
- Potential civil liability if safety issues arise
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
10. Alignment with Full MDR AR Obligations
While §124a(4)(d) reflects MDD AR duties, MDR Article 11(3) expands to:
- Explicit requirement for permanent availability
- Mandatory person responsible for regulatory compliance
- Stricter verification of manufacturer compliance
- EUDAMED registration linkage
Authorized representatives should align Slovak obligations with MDR expectations. Source: Act No. 362/2011 Coll. §124a(4)(d) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-124a.odsek-4.pismeno-d)
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