Cooperation of the State Institute for Drug Control and the Office for Technical Standardization, Metrology and State Testing
On Thursday 5 December 2024, the Director of the State Institute for Drug Control (SÚKL) Tomáš Boráň and the Chairman of the Office for Technical Standardization, Metrology and State Testing Jiří Kratochvíl signed an updated Memorandum of Cooperation.
The two Institutions agreed to act in a unified manner in national and international negotiations affecting the competences of both Parties, to act in a coordinated manner and to provide each other with expert opinions when requested by the other Party, and to jointly discuss issues of common interest in the areas of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. They will assist each other in the supervision and monitoring of notified bodies, in particular with regard to the need for expert assessment of parts of the manufacturer's technical documentation relevant to the professional agenda of the SCD. Cooperation will also continue in the resolution of disputes between device manufacturers and notified bodies.
"I very much appreciate the continuation of the existing participation of both institutions and the setting up of further development of our cooperation, today formally confirmed by the signing of the Memorandum. The area of medical device regulation is very complex. It is much more complex than in the case of pharmaceuticals, and there are more stakeholders than in the case of pharmaceuticals - notified bodies, the Ministry of Health of the Czech Republic, SÚKL, ÚNMZ, manufacturers, distributors, health service providers, consumers, so I see it as very beneficial and necessary to share and unify expert positions. Our Institute is a partner that will provide the Office for Technical Standardization, Metrology and State Testing with information from European working groups and we can certainly work together in the field of professional education," Tomáš Boráň, Director of SÚKL, appreciated the cooperation established by the memorandum.
"Considering the division of responsibilities between the designing (ÚNMZ) and competent (SÚKL) authorities at the national level, functioning cooperation and mutual information sharing are absolutely necessary to meet the requirements set out in the European Medical Devices and In Vitro Diagnostic Medical Devices (MDR/IVDR) Regulations. Our memorandum confirms the fact that ÚNMZ and SÚKL have such a functional inter-ministerial relationship. Such cooperation has, last but not least, a positive impact on the business environment in the Czech Republic." emphasized the chairman of the ÚNMZ Jiří Kratochvíl.