ElendiLabs
處方必須由具備專業資格的人員開立，並在其責任下給出特定的設計特徵（Specific Design Characteristics）。此外，必須明確聲明該設備僅供該特定患者使用（Sole use of a particular patient）。
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February 1, 2026
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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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Questions & Answers (6)
A
Anonymous
Guest
如果我的诊所使用CAD/CAM系统为患者即时切削制作全瓷牙冠，在斯洛伐克监管下，我作为“制造商”需要保留哪些核心文档？
ElendiLabs
您必须准备并保留一份声明，列明：设备描述、制造场所、特定的患者标识以及确认该设备符合基本安全与性能要求的承诺。该文档应在设备交付后至少保留10年（植入物为15年）。
A
Anonymous
Guest
Does the term "custom-made" include advanced hearing aids that are mass-produced in series but then physically molded to match the unique shape of a patient's ear canal?
ElendiLabs
No. Devices produced in series by means of industrial manufacturing processes—even if adapted to meet specific requirements—are not considered custom-made. These follow the standard regulatory pathway for mass-produced devices.
A
Anonymous
Guest
我有一位患者需要3D列印的個別化顱骨修補植入物，這類產品在斯洛伐克是否需要像普通醫療器械一樣在國家藥物管制局(ŠÚKL)進行正式註冊？
ElendiLabs
根據法案第6(4)條，定制醫療器械免於向ŠÚKL進行標準註冊。然而，製造商必須準備符合歐盟MDR附錄XIII要求的聲明，並在當局要求時隨時提供技術文件供查閱。
A
Anonymous
Guest
我们公司计划在斯洛伐克销售一种可以根据患者脚型进行热塑调整的骨科矫形鞋垫。请问这类经过适配的设备在法律上属于“定制医疗器械”吗？
ElendiLabs
不属于。根据斯洛伐克第362/2011号法案的界定，大规模生产的医疗器械（即便为了满足专业用户的特定要求而进行的适配或调整）明确排除在定制医疗器械的范围之外。
A
Anonymous
Guest
I am manufacturing a custom titanium dental bridge for a patient in Bratislava based on a 3D scan and a dentist's prescription. Does this specific case qualify as a "custom-made" device under Slovak Act No. 362/2011?
ElendiLabs
Yes, as long as it is manufactured specifically for a single patient following a written prescription from an authorized person that provides specific design characteristics, it meets the SVK definition of a custom-made device.
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Important Disclaimer
王小明
處方箋上必須包含哪些具體資訊，才能確保這件為脊椎側彎設計的背架符合定制化器械的法律定義？