15.7.2024
ARTIFICIAL INTELLIGENCE REGULATION - AI ACT
On 12 July 2024, the AI Act, Regulation (EU) 2024/1689 of the European Parliament and of the Council, was published in the Official Journal of the EU. It will come into force on 2nd August 2024, with effectiveness gradually rolling out over three years.
Manufacturers of software as a medical device that incorporates AI should therefore familiarise themselves with the Regulation now and start preparing for its implementation in order to meet all its requirements in time.
The basic requirements for AI products include, for example, correct classification into new risk classes, application of a quality management system, maintenance of technical documentation and generation of event protocols. However, the list of obligations for manufacturers is much more extensive.
Therefore, we at CMI are following the developments regarding this new regulation very intensively and are actively communicating with the Czech authorities. In addition, we have a large number of experts in artificial intelligence who are very experienced in this area and are ready to respond flexibly to the new Regulation.
Therefore, if you have any questions about the AI Regulation, please do not hesitate to get in touch with us now, we will be happy to help you.
17.6.2024
LOW FIELD MAGNETIC MRI SYSTEM
On June 13-14, experts from several European countries (DE, IT, GB, FR, NL) gathered at ČMI Medical to discuss the new low-field magnetic system MRI project. ČMI Medical is responsible for drafting the technical documentation for the entire system, and it is an honor for our representatives to collaborate with so many international experts.
15.1.2024
TRANSITION PERIOD EXTENSION
Reasons for Extension of the Transition Period
The MDR Regulation established high-quality standards and safety requirements for medical devices and in vitro diagnostic medical devices. In particular, there is a strong focus on notified body supervision, conformity assessment procedures, risk management, vigilance, market surveillance, clinical evidence requirements, PMS, PMCF, transparency and traceability.
The original date of application of the MDR was postponed to 26/5/2021 due to the pandemic and the end of the transition period was set for 26/5/2024. However, due to the lack of overall capacity of notified bodies in the EU and the resulting risk of a shortage of medical devices on the market and a public health crisis, the EU Regulation 2023/607 (Amendment to the MDR) was finally adopted, amending Article 120 of the MDR.
The Amendment was subsequently accompanied by an explanatory Questions and Answers document (Revision 1 in July 2023) which describes in more detail the various changes and the details of the use of the extended transition period.
Requirements for the Possibility of Using the Transitional Period
This Amendment brought an extension of the validity of all certificates issued under the MDD that were valid on 20/3/2023 (the date of adoption of this Regulation). This allows manufacturers to continue to place their medical devices on the market until the following dates
- 31/12/2027 for classes III and IIb implantable devices
- 31/12/2028 for classes I, IIa and the rest of IIb devices
but only if the following conditions are met:
- The medical devices continue to comply with the MDD
- No significant change can be made to the intended purpose or design of the medical devices
- Medical devices do not pose an unacceptable risk to the health or safety of patients or others
and further under the condition of performing the following actions within the specified dates:
- By 26/5/2024 the manufacturer shall implement a quality management system in accordance with MDR Article 10(9)
- By 26/5/2024 the manufacturer submits a formal application for conformity assessment to the notified body
- By 26/9/2024 the manufacturer shall sign a written agreement on conformity assessment with the notified body
In addition to the above, as of 26/5/2021 manufacturers must already comply with the provisions of the MDR regarding:
- Post-market surveillance
- Market surveillance
- Vigilance
- Registration of economic operators and devices
The surveillance of devices placed on the market under the MDD will be transferred to a new notified body with which the manufacturer has signed a written agreement from 26/9/2024 at the latest.
The Sell-Off Date Cancellation
Another innovation that the Amendment brought was the cancellation of the so-called sell-off date. According to the MDR, medical devices that were properly placed on the market according to the MDD could be supplied to the market no later than 27/5/2025. The Amendment abolished this term, thanks to which medical devices duly placed on the market can continue to be supplied to that market.
22.12.2023
On December 22, 2023, the Czech Metrology Institute (CMI) was officially designated as a Notified Body following Regulation 2017/745.
From this date, manufacturers can send non-binding inquiries and applications to CMI for the conformity assessment of their medical devices.