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October 28, 2025
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Slovakia Act No. 362/2011 §6(4)(f)(1): Exemption from Registration for Custom-Made Medical Devices
1. Legal Basis and Context
Section 6(4)(f)(1) of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices (as amended) provides a specific exemption from the general registration obligation for custom-made medical devices. This provision aligns with EU Directive 93/42/EEC (now largely superseded by MDR 2017/745) and facilitates rapid availability of patient-specific devices without full pre-market registration. Source: Act No. 362/2011 Coll. §6(4)(f)(1) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
2. Scope of the Exemption
The exemption applies exclusively to custom-made medical devices that are:
- Manufactured specifically for an individual patient based on a written prescription by a qualified healthcare professional.
- Designed and produced to meet the unique anatomical, physiological or pathological needs of that patient.
- Not mass-produced and not intended for series production.
Devices that can be adapted from standard models without significant custom design do not qualify. Source: Act No. 362/2011 Coll. §6(4)(f)(1) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
3. Conditions for Exemption
To benefit from the registration exemption, the manufacturer must:
- Obtain a written prescription or medical justification from the prescribing healthcare professional confirming the absence of suitable registered alternatives.
- Prepare and maintain technical documentation demonstrating design, manufacture, risk management and conformity with essential requirements.
- Affix CE marking (if applicable under MDR) or comply with national conformity assessment.
- Ensure traceability through unique device identification for the specific patient.
Source: Act No. 362/2011 Coll. §6(4)(f)(1) & related provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
4. Manufacturer Responsibilities Despite Exemption
Even when exempt from registration, the manufacturer remains fully responsible for:
- Safety and performance of the device.
- Risk management throughout the device lifecycle.
- Post-market surveillance and vigilance reporting to ŠÚKL in case of incidents.
- Maintaining records for at least 5 years (or 15 years for implantable devices) after the last device is placed on the market.
Source: Act No. 362/2011 Coll. cross-referenced with MDR obligations (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
5. Role of the Prescribing Healthcare Professional
The prescribing physician or qualified professional must:
- Justify in writing the medical necessity and lack of equivalent registered devices.
- Provide detailed specifications of the required device characteristics.
- Monitor clinical use and report any adverse events to the manufacturer and ŠÚKL.
This ensures the exemption is not abused for series production disguised as custom-made. Source: Act No. 362/2011 Coll. §6(4)(f)(1) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
6. Oversight by ŠÚKL
The State Institute for Drug Control (ŠÚKL) retains authority to:
- Verify compliance with exemption conditions during inspections.
- Request technical documentation and prescription justification.
- Take enforcement action (including market withdrawal) if a device is found to be non-custom-made or unsafe.
Source: Act No. 362/2011 Coll. supervisory provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
7. Practical Implications under MDR Transition
Since Slovakia transposed MDR via Act No. 171/2022 and related decrees, custom-made devices under MDR Article 1(5) continue to benefit from similar exemption principles, but with enhanced documentation, risk management (ISO 14971) and post-market surveillance obligations. Legacy custom-made devices may follow transitional rules. Source: Act No. 362/2011 Coll. §6(4)(f)(1) in context of MDR implementation (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
8. RA Manager Checklist for Exemption Use
- Confirm device meets strict custom-made definition (patient-specific, non-series).
- Secure detailed written prescription and medical justification.
- Prepare complete technical file including design verification/validation.
- Implement full risk management and PMS plan.
- Label device as custom-made with patient reference and avoid CE marking claims unless MDR-compliant.
- Monitor ŠÚKL inspections and vigilance reporting obligations.
Source: Act No. 362/2011 Coll. §6(4)(f)(1) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
9. Risks of Misclassification
Misclassifying mass-produced or adapted devices as custom-made to avoid registration can result in:
- Administrative fines.
- Product withdrawal orders.
- Potential criminal liability for endangerment to health.
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
10. Comparison with EU MDR Approach
While MDR Article 1(5) provides similar exemption for custom-made devices, Slovakia's §6(4)(f)(1) historically offered a national framework before full MDR application. Current practice combines both, with MDR taking precedence but national law filling procedural gaps (e.g., language, reporting formats). Source: Act No. 362/2011 Coll. §6(4)(f)(1) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-4.pismeno-f.bod-1)
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