On 10 July 2023, the Council of the European Union (Council) approved at first reading the European Parliament’s position on the European Commission’s proposal for a Regulation concerning batteries and waste batteries (“Batteries Regulation” or “the Regulation”). The Batteries Regulation repeals and replaces the existing Batteries Directive 2006/66/EC. The Batteries Regulation establishes new upstream and downstream requirements along the entire lifecycle of all types of batteries, including those used in medical devices, that are placed on the market or put into service in the EU regardless of where they are manufactured.
The revision of the batteries rules forms part of the Circular Economy Action Plan which is one of the main building blocks of the so-called European Green Deal, the EU’s cross-sector strategy to reach net neutrality by 2050, transition to a circular economy, restore biodiversity and reduce environmental pollution. The Batteries Regulation seeks to regulate the entities involved in the supply chain of batteries in a manner that ensures that batteries marketed and sold in the EU are sourced, manufactured and recycled in a sustainable manner.
Main obligations for economic operators
The Batteries Regulation establishes a broad range of obligations for economic operators placing batteries on the EU market. Some obligations apply horizontally to all types of batteries while others differ depending on whether the battery is a) portable, b) industrial, c) automotive; d) a starting, lightning and ignition (SLI) battery or d) an electric vehicle (EV) battery. More specifically, the Batteries Regulation introduces:
- An obligation for economic operators placing batteries on the EU market, with the exception of SMEs, to develop and implement a due diligence policy addressing the social and environmental impacts throughout their supply chain, from extraction of raw materials to disposal (Article 48). Tighter due diligence rules will require operators to verify the source of raw materials used in batteries. Compliance with due diligence obligations will be subject to audits by notified bodies.
- A requirement for batteries to undergo a conformity assessment process, be accompanied by an EU declaration of conformity and bear a CE marking of conformity to demonstrate compliance with the sustainability and safety requirements laid out in Chapter II as well as labelling, information and due diligence requirements established in Chapters III and VII of the Batteries Regulation (Articles 17-20).
- New labelling requirements including a QR code that would allow end-users to access labelling information, information about the mandatory separate collection of waste batteries and the carbon footprint, and the declaration of conformity of a battery with applicable safety and sustainability requirements (Article 13).
- A prohibition for batteries to contain hazardous substances such as mercury, cadmium and lead in concentrations specified in Annex I of the Regulation with a view to protecting human health and the environment and to manage the presence of such substances in waste (Article 6).
- The requirement for products containing portable batteries – which are used very often in medical devices – to be easily removable and replaceable by end-users (Article 11). This requirement is subject to a transitional period that ends in 2027.
- Extended producer responsibility to harmonize the rules for waste management of batteries at their end-of-life stage (Article 56). Producers of portable batteries are expected to set up a waste portable collection system with designated collection points, collect portable batteries free of charge and ensure that the collected batteries are treated in a waste management facility. The Regulation provides for the following minimum collection targets for portable devices: 45% by 31 December 2023; 63% by 31 December 2027; and 73% by 31 December 2030.
Scope of application of the Regulation
According to Article 1(3), the Batteries Regulation applies to:
“categories of batteries namely portable batteries, starting, lighting and ignition batteries (SLI batteries), light means of transport batteries (LMT batteries), electric vehicle batteries and industrial batteries, regardless of their shape, volume, weight, design, material composition, chemistry, use or purpose. It shall also apply to batteries that are incorporated into or added to products or that are specifically designed to be incorporated into or added to products”.
The material scope of the Regulation is broad enough to cover not only stand-alone batteries but also batteries incorporated into a wide range of everyday devices that are powered by electrical energy generated by batteries, such as phones, laptops and electric bicycles. This is confirmed in Recital 11 which provides that the Regulation
“should apply regardless of whether a battery is incorporated into appliances, light means of transport or other vehicles or otherwise added to products or whether a battery is placed on the market or put into service within the Union on its own”.
It also applies “regardless of whether a battery is specifically designed for a product or is of general use and regardless of whether it is incorporated into a product or is supplied together with or separately from a product in which it is to be used.” As such, batteries incorporated into medical devices or supplied together with a medical device fall within the scope of the Batteries Regulation.
Batteries that are excluded from the scope of the Regulation are those that are incorporated into equipment that relates to the protection of national security interests (arms, ammunition, etc.) and equipment intended to be sent in space (Article 1(5)).
The personal scope of application of the Batteries Regulation covers economic operators along the entire supply chain of a battery, encompassing manufacturers, authorized representatives, importers of batteries in the EU, distributors, service providers and producers. It may cover medical device manufacturers insofar as they meet the legal definition of one of the economic operators involved in the supply chain of batteries.1
What are the implications of the new rules on batteries for the med tech industry?
Considering that many medical devices incorporate portable batteries, the requirements established for portable batteries may impact the medical device industry as batteries incorporated in medical devices will have to satisfy the new upstream and downstream requirements, thus adding to the complexity of complying with regulations applicable to the medical device itself. In fact, the association representing the interests of the medical technology industry in the EU, MedTech Europe, expressed its concern regarding the proposed transitional period for compliance of portable batteries with the new electrochemical performance and durability requirements outlined in Annex III as portable batteries would have to be tested in combination with medical devices in order to ensure that patient safety and performance criteria are satisfied. According to MedTech Europe, the time required for such testing, validation and subsequent regulatory approval as well as for potential changes to the design of a device resulting from the amended batteries’ specifications would merit an additional 2-year period to transition to the new requirements.
Furthermore, the Batteries Regulation introduces certain obligations in relation to the removability and replaceability of batteries for entities that market products incorporating portable batteries. A medical device would, therefore, be considered to fulfil the removability requirement if the end-user, such as the patient or the healthcare professional, can remove the portable battery by using commercially available tools, i.e., “without requiring the use of specialised tools, unless provided free of charge with the product, proprietary tools, thermal energy, or solvents to disassemble the product”. Consequently, many medical device manufacturers will have to ensure that their products are designed in a manner that allows the end-user to readily remove and replace the battery at any time during the lifetime of the device. This requirement will not apply to professional medical imaging and radiotherapy devices and in situations where uninterrupted power supply to a device is necessary for safety purposes. Manufacturers of medical devices will also be required to ensure that their devices are accompanied by instructions and safety information on the use, removal and replacement of the batteries.
Finally, the potential phasing out of non-rechargeable portable devices appears to be a measure that could pose a challenge to general safety and performance requirements that medical device manufacturers must comply with based on sectoral legislation. This is because rechargeable batteries require more demanding device management and offer shorter battery service with the potential of affecting the safety and the performance of a medical device.
Next steps
The approval of the position of the European Parliament by the Council signals the completion of the adoption procedure for the Batteries Regulation. The final text was signed by the Presidents of the two bodies on 12 July 2023 and was published in the Official Journal of the European Union (OJEU) on 28 July 2023.2 The new Regulation will enter into force 20 days after publication in the OJEU and will apply as of 18 February 024, except where longer transitional periods apply.
Economic operators involved in the supply chain of medical devices should ensure that the batteries supplied with or incorporated in their devices meet the new standards set out in the Batteries Regulation. Medical device manufacturers may consider incorporating a clause in their purchasing or supply agreements with battery manufacturers or suppliers, affirming compliance with the Batteries Regulation's requirements.
