In a written answer on 17 July 2026, EU Health Commissioner Olivér Várhelyi outlined a two-track approach to improve transparency and regulatory oversight of continuous glucose monitoring (CGM) systems, addressing clinician and patient concerns over device quality and performance data. The Commission will develop device-specific guidance as a short-term fix while initiating the longer process of creating harmonised standards and possibly common specifications under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The answer responds to a parliamentary question from András Tivadar Kulja (EPP), who had raised worries about limited transparency in clinical performance evaluation and the lack of comparable real-world data for CGM systems. Várhelyi noted that the European Database on Medical Devices (EUDAMED) became partially mandatory on 28 May 2026, with modules for actor registration, device registration, notified bodies and certificates, and market surveillance now operational. However, the module on Clinical Investigations and Performance Studies remains under development, limiting the database's usefulness for medium- to high-risk devices like CGMs.
On standardisation, the Commission is gathering stakeholder input to update its request to European standardisation organisations (CEN and CENELEC) for new harmonised standards specific to CGMs, building on existing standards for quality management (EN ISO 13485), risk management (EN ISO 14971), and blood-glucose monitoring (EN ISO 15197). In parallel, Várhelyi said the Commission has raised with the Medical Device Coordination Group the intention to draft device-specific guidance clarifying technical requirements for CGMs. He acknowledged that developing harmonised standards or common specifications under MDR/IVDR Article 9 would take longer, so the Commission is pursuing both tracks simultaneously.
The answer signals a policy orientation toward tighter regulatory oversight and greater transparency for CGM devices, balancing patient safety with industry innovation. Stakeholders most impacted include diabetes patients and healthcare professionals, who stand to gain from more reliable performance data; CGM manufacturers, who may face new compliance costs from updated standards and guidance; notified bodies, which will need to apply the new requirements; and EU regulatory authorities, which will oversee implementation. The Commission did not set a specific timeline for the guidance or standards, but the answer suggests that device-specific guidance could emerge in the near term, with formal standards following later.