How Does The New European Batteries Regulation Affect Medical Devices?

By Josefine Sommer, Michelle Gandolfo, and George Herring, Sidley Austin

On July 12, 2023, the hotly anticipated new Regulation (EU) 2023/1542 on batteries and waste batteries¹ (“Batteries Regulation”) was adopted. The new regulation replaces the previous Directive 2006/66/EC on batteries² (“Batteries Directive”) and aims at regulating the entire battery life cycle and value chain in an integrated manner. 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 (collectively “medical devices”), such as surgical power tools, electrocardiographs, electric stethoscopes, pacemakers, robotic cameras, insulin pumps, and glucose monitors as well as smartwatches and other wearable medical devices.

The Batteries Directive And The Need For A New Batteries Regulation

The objective of the Batteries Directive is to minimize the negative impact of batteries and their hazardous components on the environment through the approximation of EU member countries’ legislation on the recovery and controlled disposal of batteries.

The extent to which these objectives were achieved was examined in a European Commission (“Commission”) evaluation published in April 2019.³ According to the evaluation, the key objectives were found to be insufficiently detailed, resulting in misalignments in the performance of individual EU member countries and distortions of the internal market.

The Batteries Regulation seeks to address the increasing use of batteries across multiple sectors,⁴ alongside the need to minimize the waste and environmental impact of raw materials used in battery production. The growing strategic importance of batteries, and the need to secure the European batteries supply chain for the long term, brought a pressing need to improve and replace the old regulatory framework.

Key Impacts On Manufacturers Of Medical Devices

In addition to applying to manufacturers of batteries, many of the provisions of the Batteries Regulation apply more broadly to economic operators involved in the supply chain of products incorporating batteries, such as battery-driven medical devices. With respect to applicable safety requirements, where other EU law sets out more specific requirements for safety reasons regarding the removal of batteries from products, those specific rules will apply instead of the Batteries Regulation.⁵

The regulation generally expands existing requirements and introduces a number of new obligations that will have a significant impact on manufacturers of medical devices, and as further explained below, especially in view of possible overlaps with the transitional provisions of the Medical Devices Regulation⁶ (MDR) or In Vitro Diagnostic Device Regulation⁷ (IVDR).

Batteries Must Be Removable And Replaceable

The Batteries Directive already required products powered by batteries to be designed in such a way that waste batteries could be readily removed. However, 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 5 kg, 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 is introduced to ensure a longer lifetime of the products into which the batteries are incorporated, so that the product does not automatically end its lifetime when the battery runs out.

Article 11 will apply three years after the application of the Batteries Regulation, namely from Feb. 18, 2027, thereby granting medical devices manufacturers a four-and-a-half-year transitional period.

For many medical devices, complying with Article 11(1) will require design changes. Manufacturers should assess the impact on their device and determine whether, for example, they could result in new risks that should be considered and addressed.

Design changes could also in some instances be considered “significant” under the transitional rules of the MDR and IVDR. Medical devices certified under the former medical devices directives⁸ and relying on the MDR or IVDR transitional provisions may continue to be placed on the market or put into service until 2025-2028 (depending on the devices), provided that certain conditions are met, including that there is no “significant change” in the design or intended purpose of the device.⁹ Medical Device Coordination Group (MDCG) guidelines on significant changes regarding the transitional provisions¹⁰ include examples of changes to design or purpose that would be deemed significant. Among these are changes that change the source of energy as well as changes that may affect the safety or performance of the device and its risk-benefit ratio.

As such, for medical devices covered by CE certificates issued under the former medical device directives, design changes implemented to comply with Article 11 of the Batteries Regulation could therefore constitute a “significant change” under the MDR and IVDR transitional provisions. As a result, manufacturers could be required to comply with the MDR or IVDR before the applicable transitional periods have expired, resulting in the device having to undergo the relevant MDR or IVDR conformity assessment in order to be placed on the market.

For certain medical devices, however, limited derogations and exemptions from the removability and replaceability requirement apply.

Derogation: Removal And Replacement By Independent Professionals

A limited derogation from Article 11 applies to certain products for which a battery can instead be designed to be removed and replaced only by independent professionals.¹¹ This applies to:

1. products that are “primarily” used in a wet environment (splashing water, water streams, or water immersion) and are intended to be washable or rinseable. This derogation only applies if there is a safety need;
2. professional medical imaging and radiotherapy devices; and
3. in vitro diagnostic medical devices.

With respect to products that are “primarily” used in a wet environment, the ingress protection rating system will likely determine whether a product may be considered within scope of the derogation.

Key for the practical functioning of this derogation is who such an independent operator may be. The batteries regulation defines the term, requiring that it must be a person who is independent from the manufacturer and the producer. However, EU member countries’ national legal frameworks and common practices in each EU member country — for example, based on technical competence requirements or liabilities – are likely to determine who can fulfill this role. The Commission has indicated its intention to issue further guidance.

Exemption: Removability And Replaceability Requirement Not Applicable

In addition to the derogation, two narrow exemptions apply to the removability and replaceability obligations 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.¹²

In practice, such legislation is likely to stem from implementing measures under the Ecodesign Directive¹³ (or under its replacement, once adopted, the Ecodesign for Sustainable Products Regulation). Today, the only EU act that falls within the scope of this exemption is the Ecodesign implementing regulation for smartphones and mobile phones,¹⁴ according to which a higher level of protection of the environment means the fulfillment 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 safety or (2) for data integrity reasons.¹⁵

Manufacturers that wish their products to fall within the scope of this exemption should keep in mind that it is to be interpreted narrowly, as safety concerns should primarily be addressed by making the battery only removeable and replaceable by independent professionals. However, it is acknowledged that the uninterrupted operation of some medical device is necessary. The Commission is required to publish guidelines to facilitate the harmonized application of Article 11, and it is understood that the Commission is currently preparing guidance to further detail the conditions applicable to fall within the scope of this exemption. For medical devices, the guidelines under preparation are likely to advise at least partly on risk classes as concrete examples. The guidelines are expected in Q2 2024.

Battery Due Diligence Policies

The Batteries Regulation now also imposes certain due diligence requirements. The new obligations apply to “economic operators that place batteries on the market or put them into service,”¹⁶ which means that only manufacturers of battery-driven medical devices that incorporate into their devices batteries that have not already been placed on the EU market are covered by the new requirements. Conversely, manufacturers of medical devices that source their batteries from within the EU – and which therefore have already been placed on the market – are not within the scope of the due diligence requirements. The rules also only apply to economic operators (including those who are part of a group) with a (consolidated) net turnover of more than 40 million euros.

The new due diligence rules require economic operators within scope to implement “battery due diligence policies.” This means that entities must, among other actions, incorporate battery due diligence provisions into contracts with suppliers, establish a control and transparency system for the supply chain, and produce and implement a policy for the supply chain of raw materials that addresses environmental and social risks in accordance with international due diligence standards. In addition, the risks of adverse impacts must be identified, prevented, or mitigated.¹⁷ The policy must be subject to a third-party verification¹⁸ and it must be disclosed to the public on an annual basis.¹⁹

The introduction of due diligence obligations represents a general European (and global) trend, especially in the context of Environmental, Social, and Governance (ESG) legislation. Once adopted, the EU Corporate Sustainability Due Diligence Directive (CSDDD), which is currently subject to continued negotiations by the EU legislators with adoption currently expected in 2024, will, for example, require covered companies to improve their corporate governance practices to better integrate risk management and mitigation processes of human rights and environmental risks and impacts into corporate strategies.

The new due diligence requirements under the Batteries Regulation may potentially place significant new burdens on medical device manufacturers, which should immediately assess whether they are within scope or not. Covered entities should ensure that the due diligence requirements are incorporated into their overall ESG policies and that they comply with applicable transparency requirements.  

The new due diligence rules apply beginning Aug. 18, 2025, and the Commission is required to publish guidelines concerning their application by February 2025.²⁰

Management Of Waste Batteries

Lastly, a number of new requirements are introduced by the Batteries Regulation with regard to management of waste batteries. Obligations related to waste management have been greatly expanded.

The waste management obligations target the “producer,” which covers a broad category of economic operators involved in the battery value chain who are established in an EU member country and/or sell in a member country – including manufacturers, importers, distributors, and other natural or legal persons.²¹ This approach implies a broad application of the waste management requirements to companies involved in the supply chain of medical devices.

The new and expanded requirements include:

• Extended producer responsibility (new). The extended producer responsibility (EPR)²² applies to producers of batteries they make available within the territory of an EU member country. Producers must establish battery take-back systems, offering free collection and transportation services, and ensure that batteries are subsequently processed at appropriate facilities.²³
• Collection targets (expanded). The regulation improves the minimum collection targets,²⁴ and producers must now meet specific incremental collection targets, i.e., 45% by December 2025, 63% by December 2027, and 73% by December 2030.
• Information to end users (new). Producers must make available to end users and distributors information on the management of waste batteries, such as the separate collection and available reuse/recycling systems and safety instructions.²⁵

Medical device manufacturers that fall within the scope of these requirements should monitor changes to national implementing requirements. It is possible that the Commission will publish guidance or an FAQ list relating to the waste management rules.

What’s Next For Impacted Companies?

The Batteries Regulation will start applying on Feb. 18, 2024,²⁶ except for some obligations such as those under Article 11 that will apply later, and will be directly applicable throughout the EU.

Overall, the regulation will impose additional burdens on medical device manufacturers, potentially impacting device designs, ESG policies, and waste management operations.

Medical device companies should start conducting internal assessments to ascertain whether your devices meet any of the derogation or exemption criteria to the removability and replaceability requirement. You should also consider whether changes to the design of your devices are necessary and start discussions with your notified body²⁷ to conduct the necessary evaluations. In addition, companies within scope of the due diligence requirements should assess the status of their internal ESG policies against the provisions of the regulation.

References

1. Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC, available here.
2. Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC, available here.
3. See Commission Staff Working Document on the evaluation of the Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (“Commission Staff Working Document”), available here.
4. See Batteries Regulation, Recital 10.
5. See Batteries Regulation, recital 38.
6. Regulation (EU) 2017/745 on medical devices, available here.
7. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, available here.
8. Council Directives 90/385/EEC, 93/42/EEC and Directive 98/79/EC.
9. See MDR, Article 120(2) and (3); and IVDR, Article 110(2) and (3).
10. MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD, available here; and MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR, available here.
11. See Batteries Regulation, Article 11(2).
12. See Batteries Regulation, Article 11(1), fourth subparagraph.
13. Directive 2009/125/EC establishing a framework for the setting of ecodesign requirements for energy-related products.
14. Commission Regulation (EU) 2023/1670 of 16 June 2023 laying down ecodesign requirements for smartphones, mobile phones other than smartphones, cordless phones, and slate tablets.
15. See Batteries Regulation, Article 11(3).
16. See Batteries Regulation, Article 48.
17. See Batteries Regulation, Article 49-50.
18. See Batteries Regulation, Article 48(2) and 51.
19. See Batteries Regulation, Article 52.
20. See Batteries Regulation, Article 47.
21. See Batteries Regulation, Article 3(47).
22. See Batteries Regulation, Article 56.
23. See Batteries Regulation, Article 59(1).
24. See Batteries Regulation, Article 59(2).
25. See Batteries Regulation, Article 74.
26. See Batteries Regulation, Article 96.
27. A notified body is an organization designated by one or more EU member countries to assess the conformity of certain products with EU legislation.

About The Authors:

Josefine Sommer is a partner in Sidley’s Global Life Sciences and Environmental practices based in Brussels. She assists clients in regulatory, compliance, and enforcement matters. She counsels medical device, pharmaceutical, and biotech companies on EU regulatory compliance, including in clinical trials, authorizations, and regulatory authority interactions. She additionally advises clients on EU environmental law, including chemicals legislation impacting medical devices, pharma, and biotech as well as consumer products. Sommer handles GCP, cGMP, quality management system (QMS), data integrity, product recalls, and adverse event reporting matters, and also represents companies in regulatory enforcement actions.

Michelle Gandolfo is a managing associate in Sidley’s Global Life Sciences practice, located in the firm’s Brussels office. She advises life sciences clients throughout their product life cycle, from clinical development programs to marketing authorization pathways and post-market regulatory and compliance issues. Gandolfo assists clients on a variety of regulatory and compliance issues relating to medicinal products, medical devices, biotechnology, food, and cosmetics. She also supports clients conducting internal investigations in developing, auditing, and enhancing compliance programs, and advises clients in matters related to GMP, environmental social governance (ESG), and sustainability issues.

George Herring is an associate in Sidley’s Global Life Sciences practice, based in the firm’s London office. He advises a range of clients within the life sciences industry, including medicinal product, medical device, and food companies, on the interpretation of the EU- and UK-applicable legal framework, regulatory compliance, market access strategy, and optimization of IP regulatory rights. Herring also has commercial experience, working in-house at a major biotechnology company, advising on data privacy and transparency matters alongside contracting arrangements with healthcare professionals and third-party vendors.