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Please find below the latest regulatory news in Europe.

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MedTech Europe's vision for cybersecurity in the medical technology ecosystem:

The main topics of this document are:

Regulation and Safety: It emphasizes the importance of patient safety and data security in the context of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Ransomware: MedTech Europe is committed to combating ransomware and other malicious activities that threaten healthcare delivery. It supports legislative interventions to enhance cybersecurity.

Cybersecurity Education: The paper advocates for improving digital literacy and cybersecurity skills through public-private partnerships. It acknowledges the European Commission's efforts, such as the European Skills Agenda Digital Education Action Plan and the Cybersecurity Skills Academy.

For more detailed information please read the document on your own.

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EUDAMED user guide - UDI Devices Production v 2.11:

The main topics of this document are:

Basic UDI-DI Identification Details: The guide provides instructions on how to fill in the Basic UDI-DI identification details. EUDAMED will validate the Basic UDI-DI code based on the specific format for each Issuing Entity and will prevent you from going further if the code is not valid. If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you from saving, as a Basic UDI-DI must be unique.

Special Device Types: The guide notes that it is currently not possible to register devices with certain special device types, including standard soft contact lenses, rigid gas permeable (RGP) contact lenses, made-to-order soft contact lenses, spectacle frames, spectacle lenses, and ready-made reading spectacles (Page 8).

UDI-DI Code: The guide provides instructions on how to enter the UDI-DI code, which must be a 14-digit code including the check digit that will be used by EUDAMED to validate the UDI-DI code. If the GS1 UDI-DI (GTIN code) is less than 14 digits, leading zeros should be added until it reaches 14 digits (Page 12, 39).

Managing Device Information: The guide provides detailed instructions on how to manage device information, including how to delete a draft Basic UDI-DI/EUDAMED DI, how to update (create a new version) for Basic UDI-DI/EUDAMED DI, and how to view historical versions for Basic UDI-DI/EUDAMED DI (Page 48).

Discarding Registered UDI-DIs/EUDAMED IDs: The guide explains that the discard operation acts as a final deactivation. A device in state discarded is therefore not listed and cannot be viewed in the public site of EUDAMED. However, it can be viewed by the Manufacturer (owner of the discarded device), Competent Authority, and Notified Body actors (Page 62).

For more detailed information please read the document on your own.

​Link to document​

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