On March 28, 2025, we once again actively participated as presenters at Innovation Day 2025, following our previous attendance in November 2023. The event was organized by NIMOTECH, s.r.o.
The focus of the event was on innovations in diagnostics, particularly in advanced ultrasound examination methods (gynecology, cardiology, orthopedics, physiotherapy, and radiology), electrosurgery, and surgical/examination lighting. Additionally, products from United Imaging were showcased, including magnetic resonance imaging (MRI), computed tomography (CT), nuclear medicine, and mammography equipment.
Our presentation focused on recent developments in medical device regulation, specifically:
- The possibility of extending the transitional period for devices compliant with previous directives (Regulation (EU) 2023/607 of the European Parliament and of the Council) and the conditions for such extension.
- Updates on the implementation of the EUDAMED database (Regulation (EU) 2024/1860).
- New obligations for manufacturers to notify in the event of supply interruptions or discontinuations (Regulation (EU) 2024/1860).
- The establishment of a new notified body for medical devices – the Czech Metrology Institute (previously announced on our website).
- The amendment of Act No. 375/2022 Coll. by Act No. 241/2024 Coll.
- The launch of the Medical Devices Information System (ISZP) (we reported on this on our website here, here, here, and here).
We also addressed the topic of medical device registers in the Czech Republic, explaining changes in the Register of Medical Devices (RZPRO) and the Medical Devices Information System (ISZP). Furthermore, we described the gradual rollout of the EUDAMED database and its link to the national regulatory framework.
Given that the event targeted biomedical technicians and engineers, the final part of our presentation focused on the management, use, and servicing of medical devices. This included a review of offenses under Act No. 375/2022 Coll., and a summary of fines issued by the State Institute for Drug Control in 2023 and 2024 in the field of medical devices.
Beyond the presentation, there was also time to answer participants’ questions and share experiences, particularly regarding the implementation of requirements under the Medical Devices Act.
Our Services
If you need assistance navigating the complex and ever-changing legislation surrounding medical devices, feel free to contact us via email at medecorp@medecorp.cz or through the contact form on our website www.medecorp.cz.
We are happy to support you with:
- Placing a medical device on the market,
- Creating technical documentation,
- Managing the complete regulatory affairs agenda within your company,
- Medical device asset management and servicing.
A complete list of our services is available on our website.