An update regarding the EU F Gas regulations that apply in the EU and in Northern Ireland. F gases are fluorinated gases used as refrigerants, in heat pumps, air conditioning, but also covers anaesthetics, all of which are significant greenhouse gases much more potent than carbon dioxide. In the revised EU regulation, some categories of devices that use/contain F Gases are due to be banned from 1st Jan 2025, and manufacturers are required to substitute for more environmentally friendly alternatives, unless an exemption has been sort by the individual manufacturer/importer for the specific device / application.
Manufacturers/Importers need to submit applications for exemptions under Article 11(c). If you require an exemption, you need to submit a letter on headed paper to the competent authorities (MedTech Europe are confirming if it needs to be just one, or every member state, on which you place product) that you are placing product on the market.
For the letter you need to provide the following information (note that the list is unofficial, but a suggestion of what is required). The European Commission and Competent Authorities are due to meet at the end of September to review any submissions, so manufacturers / importers need to make a submission as soon as possible, or risk not having the exemption approved by the 1st Jan 2025 deadline. The EC are then required draft delegated legislation and to enter into a period of comitology, which must be completed before the 1st Jan 2025 deadline. The exemption needs to be published in a delegated act before 1st Jan 2025.
Members continue to raise uncertainty regarding device classification e.g. Centrifuges, and other laboratory equipment that are not fridges, freezers, chillers, what category do these fall into? Cat 5c? or under the classification for self-contained with refrigeration? It’s agreed that classification of laboratory equipment is unclear. If it’s Cat 5c then we have a longer timeline and the 1st Jan 2025 deadline does not apply.
Suggested topics to be addressed in the submission letter:
- What specific F-gas(es) do you need the exemption for?
- What application / medical technology is the F-Gas used in?
- What volume of F-Gas is used per year, and per device for these applications?
- Why is the exemption request needed? i.e. you cannot substitute
- What challenges do you have with substitution? If it’s related to IVD substitution timeline and NB approval then detail this. The time period from legislation publication and first deadlines is only 12 months and this is proving difficult for members.
- Do you have a timeline for substitution? What efforts have been made to substitute?
- What impact would a ban have e.g. economic, but also on patients?
Some members have highlighted, that upon investigation that some alternatives are not safe for use with existing equipment e.g the alternative is flammable, and the equipment is not designed for safe use with flammable liquids/gases. This and the longer transition period required to meet IVD sectorial legislation may prove effective arguments, however the long-term goal of the F Gas regulation is to ban the use of F gases, wherever possible, and any exemption granted is likely to be time-bound, and with additional requirements, e.g. annual reporting, and tracking of substitution progress.
Note also that the European Commission and member states will review all applications and will compare manufacturers responses, so If solutions are being identified in some products by some manufacturers and others do not appear to be making progress, then exemptions may not be granted to those falling behind the curve.
