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February 1, 2026
Approximately 5 minutes
Slovakia Act No. 362/2011 §6(1)(c): Definition and Scope of Custom-Made Medical Devices
Slovakia Act No. 362/2011 §6(1)(c): Definition and Scope of Custom-Made Medical Devices
1. Legal Provision and Context
Paragraph 6(1)(c) of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices (as amended) provides the statutory definition of custom-made medical devices in the Slovak legal framework. This definition is crucial for regulatory classification, conformity assessment pathways, and exemptions from full registration obligations with the State Institute for Drug Control (ŠÚKL). It aligns with the former EU Medical Devices Directive 93/42/EEC and continues to serve as a reference under the transitional application of Regulation (EU) 2017/745 (MDR). Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
2. Official Definition of Custom-Made Device
A custom-made medical device is defined as any device specifically made in accordance with a written prescription of a physician or other person authorized to provide health care services, which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient. The prescription must specify the design features necessary to ensure the device meets the individual needs of that patient. Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
3. Key Elements Required for Qualification
To qualify as custom-made under this provision, the device must fulfil all of the following cumulative criteria:
- Specific prescription: Written order from a qualified healthcare professional (physician or equivalent) bearing professional responsibility.
- Unique design characteristics: Design adapted to the individual anatomical, physiological or pathological condition of the specific patient.
- Sole use for one patient: Explicitly intended for exclusive use by the named patient; not for general or multiple-patient application.
- Non-series production: Not manufactured using standard series production methods or intended for repeated identical production.
Devices adapted from catalogue models with only minor modifications typically do not meet the threshold. Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
4. Distinction from Mass-Produced and Adapted Devices
The definition explicitly excludes:
- Devices produced in series even if subsequently adapted for a patient.
- Standard catalogue devices with only minor adjustments (e.g., size/color changes).
- Off-the-shelf products prescribed without specific design modifications.
This prevents circumvention of full conformity assessment and registration requirements for what are effectively standard devices. Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
5. Regulatory Consequences of the Definition
Devices meeting §6(1)(c) criteria:
- Are exempt from standard registration/notification with ŠÚKL (cross-reference to §6(4)(f)).
- Must still comply with essential safety and performance requirements.
- Require manufacturer to prepare technical documentation, risk management file, and labelling as “custom-made device”.
- Fall under MDR Article 1(5) scope during transition, maintaining similar exemption principles but with stricter PMS and vigilance obligations.
Source: Act No. 362/2011 Coll. §6(1)(c) in conjunction with MDR transposition (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
6. Documentation and Evidence Requirements
To substantiate custom-made status:
- Retain the original written prescription with patient-specific design specifications.
- Maintain design history file showing how the device was adapted to the individual need.
- Document justification that no equivalent registered device was available.
- Keep records available for ŠÚKL inspection for at least 5 years (15 years for implantables).
Source: Act No. 362/2011 Coll. §6(1)(c) & related obligations (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
7. Practical Implications for Manufacturers and Healthcare Providers
- Manufacturers: Use this definition to justify exemption; ensure robust documentation to defend status during audits.
- Healthcare professionals: Provide detailed, patient-specific prescriptions; avoid generic requests that could invalidate custom-made classification.
- ŠÚKL: May challenge classification if evidence suggests series production or lack of true individual adaptation.
Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
8. Transition to MDR Framework
With Slovakia’s full MDR application (via Act No. 171/2022 and decrees), the national definition in §6(1)(c) continues to guide interpretation, but MDR Article 2(3) and Article 1(5) now provide the primary EU-harmonized criteria. Manufacturers should align documentation with MDR Annexes while referencing national law for procedural aspects. Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
9. RA Manager Checklist for Classification
- Does the device have patient-specific written prescription with unique design specs?
- Is it intended solely for one named patient?
- Was it designed and manufactured specifically for that patient’s condition?
- Are production methods non-series / non-repetitive?
- Is there documented evidence no equivalent registered device exists?
- Is full technical file and risk management prepared?
Source: Act No. 362/2011 Coll. §6(1)(c) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
10. Risks of Incorrect Classification
Incorrectly classifying a device as custom-made when it does not meet §6(1)(c) criteria may lead to:
- Administrative sanctions by ŠÚKL.
- Requirement for retrospective registration/conformity assessment.
- Potential product withdrawal or market restrictions.
Source: Act No. 362/2011 Coll. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2011/362/#paragraf-6.odsek-1.pismeno-c)
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