Sidley Austin’s Josefine Sommer, partner specialising in food, drug and medical device regulation, outlines how new European battery regulations may impact medical device manufacturers in the UK.
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EU regulations concept
In July 2023, the EU adopted the hotly anticipated Regulation (EU) 2023/1542 on batteries and waste batteries (Batteries Regulation). The Regulation, which replaces the former Batteries Directive, marks a step change towards achieving the EU’s climate neutrality goal by 2050. Batteries are a key focus area as they are considered one of the key enablers for ensuring a safe, circular, and sustainable batteries value chain.
The Batteries Regulation will apply from 18 February 2024, except for some obligations which will apply later, and it will be directly applicable in all the EU Member States.
The new regime applicable in the EU must be complied with by not only EU-based companies, but also by any UK-based operator who places or puts into service batteries and battery-powered products on the EU market.
The impact of the new regime will be felt not only by the usual battery-driven industries such as consumer technologies and electric cars, but also by manufacturers of battery-powered medical devices and in vitro diagnostic devices and causing possible overlaps with the transitional provisions of the Medical Devices Regulation (MDR) or In Vitro Diagnostic Device Regulation (IVDR). Impacted companies may need to conduct internal assessments to ascertain whether their devices are subject to the obligations of the new Batteries Regulation, and whether they may benefit from any of the exemptions or derogations.
Design changes: Batteries must be removable and replaceable
A key new requirement is set out in Article 11(1) of the Batteries Regulation, which requires portable batteries – i.e., sealed batteries weighing less than 5kg, which are not designed for industrial purposes and are not electric vehicle or automotive batteries – to be “readily removable and replaceable” by the end-user during the lifetime of the product.
This requirement aims to ensure a longer lifetime of products incorporating batteries, so that these products do not automatically end their lifetime when the batteries run out.
Article 11 will apply three years after the application of the Batteries Regulation, namely from 18 February 2027.
For some devices, Article 11(1) will require design changes as new designs may be necessary to accommodate the removability and replaceability requirements. Such design changes may in some instances be considered ‘significant’ as the term is used in the transitional provisions of the MDR and IVDR.
The importance of a design change being considered ‘significant’ is fundamental for devices certified under the former Device Directives and which rely on the MDR and IVDR transitional provisions to remain on the EU market. This is because these devices may only continue to be placed on the EU market or put into service until 2025-2028 (depending on the devices), if certain conditions are met, including that there is no significant change in the design or intended purpose of the device. According to the Medical Device Coordination Group (MDCG) guidelines on significant changes regarding the transitional provisions, changes of the source of energy of the device are examples of changes to the design or purpose that could be deemed ‘significant.’
Design changes on devices covered by CE certificates issued under the former Device Directives could therefore require manufacturers to comply with the MDR or IVDR before the applicable transitional periods have expired, resulting in the impacted devices having to undergoing the relevant MDR or IVDR conformity assessments in order to be placed on the EU market.
For certain devices, however, limited derogations and exemptions from the removability and replaceability requirement apply.
The Batteries Regulation requires the Commission to publish guidelines to facilitate the harmonised application of the removability and replaceability rules. Recently, the Commission’s science and knowledge service providing independent scientific advice, the Joint Research Centre (JRC), published its draft technical input in support of the development of such guidelines (the Technical Input). The Technical Input aims, in particular, to provide guidance in relation to the derogations and exemptions.
Derogations – removal and replacement by independent professionals
Limited derogations from Article 11 apply to certain products from which a battery can instead be designed to be removed and replaced only by independent professionals. This applies to:
- products that are “primarily” used in a wet environment and are intended to be washable or rinseable. This derogation only applies if there are safety needs;
- professional medical imaging and radiotherapy devices; and
- in vitro diagnostic devices.
Key for the practical functioning of this derogation is the term ‘independent professional.’ According to the JRC, independent professionals are operators who have the technical competence to repair devices with integrated batteries, who conduct their business in commercial premises, and who comply with applicable national regulations for repairers of electrical equipment in the EU Member States where they operate. The EU Member States’ national legal frameworks and common practices are therefore likely to determine who can fulfil this role.
Exemptions – removability and replaceability requirement not applicable
In addition to the above derogations, two narrow exemptions apply, such that products that fall within their scope do not have to meet the removability and replaceability requirement.
The exemptions apply to:
- Electrical and electronic equipment (EEE) on which EU law imposes a higher level of protection of the environment and human health relating to the removability and replaceability of portable batteries.
In practice, such legislation is likely to stem from implementing measures under the Ecodesign Directive (or under its replacement, once adopted, the Ecodesign for Sustainable Products Regulation). Today, the only EU act that appears to interact with Article 11(1) is the Ecodesign Implementing Regulation for smartphones and mobile phones, according to which a higher level of protection of the environment means the fulfilment of the applicable disassembly/durability requirements in its Annex II.
- Products where continuity of power supply is necessary and a permanent connection between the device and the portable battery is required (1) for safety reasons, or (2) for data integrity reasons.
Manufacturers who wish their products to fall within the scope of this exemption should bear in mind that it will be interpreted narrowly, as safety concerns should chiefly be addressed by making the battery only removeable and replaceable by independent professionals.
When referring to safety reasons, the JRC suggests in its Technical Input that the classification system under the MDR/IVDR should be used to (help) identify devices which would benefit from the exemption. For example, the JRC suggests that the exemption should apply to Class III/D devices when the lack of continuity of power supply and a break of connection between the device and the battery entails a risk of compromising the user safety such as for certain software intended to provide information for diagnostic or therapeutic decisions.
The JRC also suggests that devices which are excluded from the scope of the Directive on Waste Electrical and Electronic Equipment (WEEE Directive), namely devices which are “infective prior to end of life” and active implantable devices, should fall within the scope of the Battery Regulation’s exemption for “safety reasons.”
When referring to data integrity reasons, the JRC clarifies that data collection and supply must be the main function and that the specific reason justifying the exemption must relate to data integrity. Examples of devices which would fall within the scope of the exemption for “data integrity reasons” include batteries whose main function is to power a non-volatile memory itself, such as those found in sensors or medical devices, where the continuity of power supply is deemed necessary for data integrity reasons. Examples included in the Technical Input are blood glucose monitors and devices used for dialysis treatments.
What’s next for impacted companies?
The Batteries Regulation will apply from 18 February 2024. However, the replaceability and removability requirement – as well as some other requirements – will start applying three years later, from 18 February 2027.
Overall, the Batteries Regulation will impose additional burdens on devices manufacturers, potentially impacting the design of their devices and could potentially require some manufacturers to transition their devices to the MDR or IVDR ahead of the planned schedule.
EU and non-EU devices companies wishing to place or put into service devices in the EU market should consider conducting internal assessments to ascertain whether their devices meet any of the derogation or exemption criteria to the removability and replaceability requirement. They should also consider whether changes to the design of their devices are necessary and start discussions with their Notified Body to conduct the necessary evaluations.
