EU MDR compliance support for Tissue Perfusion Imaging Device
Supporting Pharma companies to follow New F-Gas Regulation (EU) 2024/573
Project Summary
A leading pharmaceutical MAH for MDIs partnered with Celegence to comply with the new F-Gas Regulation (EU) 2024/573. Celegence supported portal registration, quota calculations, reporting, and labeling updates. This ensured quota allocation, seamless compliance, supply continuity, and a sustainable framework for ongoing regulatory adherence.
Challenges
With the introduction of Regulation (EU) 2024/573, the client needed to ensure compliance with strict F-Gas requirements.
- Limited understanding of new regulation
- Not aware of the new requirements such as registering in F-Gas portal, Quota calculation, Quota Authorisation, Labelling requirements etc.
Highlights:
Assisted the client in registering on the EU F-Gas Portal
Ensured correct categorization of MDIs under medical exemptions while aligning with compliance obligations
Gathered historical data on propellant use across product lines
Standardized calculation models to estimate annual consumption under the new regulation
Identified authorized quota holders within the EU
Facilitated communication and agreements to secure quota allocations for continued supply
Prepared and submitted timely reports via the F-Gas Portal
Ensured data accuracy in line with EU reporting templates
Reviewed existing packaging and labelling
Implemented updates to meet new requirements on F-Gas content disclosure
Project Achievements
The client achieved seamless compliance with the 2024 regulation
Secured F-Gas quota to safeguard MDI production and supply continuity
Enhanced transparency through accurate reporting and updated labelling
Built a sustainable framework for ongoing regulatory adherence
Need Support with EU F-Gas Regulation (2024/573)?
Celegence helps pharma companies secure quotas, manage F-Gas reporting, and update labelling for MDI products—ensuring compliance and supply continuity. Email us at info@celegence.com to discuss your regulatory needs.
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19 Sep, 2025
25 Aug, 2025
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