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January 5, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §103: Authorized Representative Registration and Notification Requirements
Slovakia Act No. 362/2011 §103: Authorized Representative Registration and Notification Requirements
1. Legal Provision Overview
Section 103 requires any person established in Slovakia intending to act as an authorized representative for a manufacturer not established in the European Union to:
- Register with the State Institute for Drug Control (ŠÚKL) prior to commencing activities
- Notify ŠÚKL of any changes in registration particulars
- Annually confirm continuation of the authorization
This provision transposes MDD Article 10 obligations for local representation. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
2. Who Must Register
Registration is mandatory for:
- Natural or legal persons with registered office or place of business in Slovakia
- Acting as authorized representative for non-EU manufacturers
- Representing any class of medical devices (I to III, including custom-made)
Foreign-based ARs without Slovak establishment are not covered by this section. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
3. Registration Process and Content
The registration application to ŠÚKL must include:
- Identification of the authorized representative (name, address, company registration)
- List of represented non-EU manufacturers
- Scope of represented devices (classes, types)
- Contact details for vigilance and technical documentation
ŠÚKL issues a registration confirmation upon compliance. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
4. Notification of Changes
The authorized representative must notify ŠÚKL without undue delay of:
- Changes in identification, address, or legal form
- Addition or removal of represented manufacturers
- Changes in scope of represented devices
- Termination of authorization for any manufacturer
Failure to notify may lead to sanctions or deregistration. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
5. Annual Confirmation Requirement
Each year, the authorized representative must submit to ŠÚKL:
- Confirmation that the authorization continues for each represented manufacturer
- Updated list of manufacturers and device scopes if changed
- Statement of compliance with AR obligations
This serves as ongoing verification of active representation. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
6. MDR Transition Application
For legacy devices under MDD transitional provisions (MDR Article 120):
- §103 registration and notification duties continue until MDD certificate expiry
- After transition, MDR Article 11 requires similar but more detailed AR registration in EUDAMED
- Slovak ARs must prepare for dual compliance during transition
Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
7. Practical RA Guidance for ARs
- Maintain a dedicated Slovak registration file with all submissions to ŠÚKL
- Set calendar reminders for annual confirmation (typically by end of Q1)
- Implement change control process for manufacturer additions/removals
- Keep evidence of ŠÚKL confirmations and notifications for audits
- Coordinate with non-EU manufacturers to ensure timely updates
- Prepare for potential ŠÚKL verification audits
Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
8. Common Compliance Issues
- Failure to notify manufacturer termination promptly
- Incomplete annual confirmation submissions
- Outdated registration details after company changes
- Missing documentation of ŠÚKL confirmations
- Delays in notifying scope expansions
Source: Act No. 362/2011 Coll. §103 practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
9. Enforcement and Risks
Non-compliance with §103 may result in:
- Administrative fines
- Order to cease representing manufacturers
- Deregistration as authorized representative
- Potential impact on market access for represented devices
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
10. Alignment with MDR AR Registration
While §103 implements MDD AR registration, MDR Article 11 introduces:
- Mandatory EUDAMED registration for ARs
- Stricter verification of manufacturer compliance
- Person responsible for regulatory compliance requirement
- Enhanced annual reporting obligations
Authorized representatives should align Slovak duties with MDR expectations. Source: Act No. 362/2011 Coll. §103 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-103)
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