In 2026, the Czech Metrology Institute, together with the non-profit organization GS1 Czech Republic, will organize regular seminars on the following dates:
05 February 2026 – Planned workshop topic: EUDAMED and UDI, including the obligations of economic operators under the MDR.
21 May 2026 – Seminar cancelled due to insufficient participation.
17 September 2026 – Planned workshop topic: The Machinery Directive in relation to medical devices, medical device risk analysis, and the obligations of economic operators. Registration will open soon.
26 November 2026 – Planned topic: Quality Management System and Technical Documentation for Medical Devices.
* Program subject to change. In addition to regular seminars and workshops, we are preparing "roundtable discussions" on current topics such as cybersecurity, 3D printing, manufacturing of medical device components, the AI Act, biological and clinical evaluation, and more.
As of 1 July 2024, the 2025.pdf">Certification Body for Management Systems Certification was established within the organizational structure of the Czech Metrology Institute. It is currently accredited by the Czech Accreditation Institute (ČIA), o.p.s., as Body No. 3266 in key technical areas covering non-active and active medical devices, their manufacture, sterilization, distribution, maintenance, and servicing. More information can be found here.
CMI also acts as a Notified Body NB 1383 for the conformity assessment of medical devices under Regulation (EU) 2017/745 on Medical Devices (MDR). The international standard ISO 13485, which is harmonized with the MDR, is recognized as a means of meeting MDR requirements.
Thanks to the overlap between ISO 13485 requirements and MDR requirements, CMI provides comprehensive services ensuring the independent conformity assessment of medical devices and documented, implemented quality management systems for manufacturers, authorized representatives, importers, distributors, and service providers (economic operators), as well as for organizations performing sterilization and other parties handling medical devices. These services are also available to external suppliers providing products such as raw materials, device parts, accessories, components, subassemblies, calibration services, and maintenance services.
Through this approach, CMI helps optimize the conformity assessment processes for medical device quality management systems in accordance with regulatory requirements and facilitates the placement of safe and effective devices on the EU market.
Information about the Certification Body for Management Systems Certification can be found /department/165">here.
To help improve the quality of COSM CMI services, please complete our Customer Satisfaction Survey. The questionnaire is available here.
More information here