Updates to Medical Devices Regulations 2023: Registration of Systems and Procedural Kits in the National Database
As of October 26, 2023, significant changes have come into effect regarding the management of information related to medical devices, allowing for the input of data for both systems and procedural kits into the national database. This update is based on the provisions outlined in Article 22, paragraphs 1 and 2 of Regulation (EU) 2017/745, taking into account the new directives established by Regulation (EU) 2023/607.
The registration of systems and procedural kits requires the accurate specification of information dictated by Regulation (EU) 2017/745. Specifically, in the case of systems and procedural kits sterilized before market introduction, as indicated in Article 22, paragraph 3, it is mandatory to attach the corresponding certificate issued by the Notified Body.
For devices already certified according to previous directives, the validity of CE certificates will now be determined based on the new provisions of Regulation (EU) 2023/607. Additionally, the expiration date of certificates will be automatically updated by the system, simplifying the information management process.
In the case of Class I medical devices with CE marking, following Directive 93/42/EEC, and for which the conformity assessment procedure according to Regulation (EU) 2017/745 involves a Notified Body, the system will offer selectable options. Once chosen, these options will automatically determine the final date for placing the device on the market, making the process more flexible and adaptable to different situations.
In summary, these new provisions aim to enhance efficiency and accuracy in the registration and management of information on medical devices, ensuring adequate compliance with current regulations and directives, thereby promoting the safety and effectiveness of medical devices on the market.
Prepare Your Medical Devices for the Future: Compliance with the New Regulations 2023.
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