Czech Office for Technical Standardization, Metrology and State Testing (ÚNMZ) - Medical Devices Overview

The Czech Office for Technical Standardization, Metrology and State Testing (ÚNMZ) is a state administration body under the Ministry of Industry and Trade of the Czech Republic. In the medical devices sector, ÚNMZ primarily oversees technical standardization, metrology, and the designation and supervision of Notified Bodies (Authorized Organizations) responsible for conformity assessment.

Regulatory Framework

Medical device regulation in the Czech Republic complies strictly with the European Union's New Legislative Framework (NLF):

• EU Medical Device Regulation (MDR) 2017/745: Replaces the older Council Directive 93/42/EEC and outlines general safety and performance requirements.
• National Legislation: Supported by Act No. 89/2021 Coll. on medical devices, Act No. 90/2016 Coll., and accompanying decrees (Decree No. 186/2021 Coll. and Decree No. 170/2021 Coll.).

Key Roles and Responsibilities of ÚNMZ

• Notified Bodies Oversight: ÚNMZ authorizes and supervises the bodies conducting conformity assessments. In the Czech Republic, notable entities include:

• AO 201: Electrotechnical Testing Institute (Elektrotechnický zkušební ústav, s.p. - EZÚ)

• AO 224: Institute for Testing and Certification (Institut pro testování a certifikaci, a.s. - ITC)

• Technical Standardization: Ensures the integration of harmonized European standards under the MDR into national frameworks to guide domestic manufacturers.

• Metrology and State Testing: Regulates measuring equipment and testing protocols to ensure accuracy in medical applications.

• Annex XVI Products: Handles the expanded regulation under MDR for products without an intended medical purpose (e.g., non-prescription colored contact lenses, dermal fillers, liposuction devices, IPL epilators).

While market surveillance and professional acts are shared with the State Institute for Drug Control (SÚKL), ÚNMZ serves as the foundational authority for technical quality, conformity infrastructure, and standardization.