By David , Lead Battery Systems Engineer, TEFOO
Last updated: November 2026 · Next scheduled review: Q1 2027 · Reviewed by TEFOO Regulatory & Quality Team
1. Executive Summary
Regulation (EU) 2023/1542 on batteries and waste batteries entered into force on 17 August 2023 and began its phased application on 18 February 2024, replacing the former Battery Directive 2006/66/EC. For medical device original equipment manufacturers (OEMs) and the battery-pack integrators who supply them, the regulation is no longer a distant environmental policy: the most design-relevant obligation — the end-user removability and replaceability of portable batteries incorporated into appliances — starts to apply on 18 February 2027.
Medical devices are not uniformly exempt from 2023/1542. The regulation applies a tiered derogation structure, and whether your pack is classified as a portable battery, an industrial battery (>2 kWh), an LMT battery or an implantable device determines which obligations actually land on your product. This guide walks through the classification logic, the medical-device derogations, the compliance timeline, and the engineering and supply-chain actions needed before the 2027 deadline.
This article is written from a battery-systems engineering perspective and reflects the consolidated text of Regulation (EU) 2023/1542 together with Commission guidance published in 2025–2026, including Commission Notice C/2025/214 on removability and the Commission Delegated Regulation of 14 July 2026 refining the medical derogations. Where a Commission delegated or implementing act is still in draft at the time of writing, it is flagged as such in the text.
About the Author
David is Lead Battery Systems Engineer at TEFOO, where he has spent 12 years designing Li-ion battery packs for medical and industrial instruments — including patient monitors, handheld ultrasound, infusion pumps and industrial PDA devices. He has led programs certified to ISO 13485, IEC 62133-2 and UN 38.3, and supports EU OEM customers through MDR/IVDR technical-file preparation and EU Battery Regulation compliance.
2. Why This Matters in 2026–2027
From November 2026, design freezes for units shipping into the EU in 2027 are already underway. A battery compartment that is glued shut, a pack sealed for IP rating, or a service manual that assumes factory-only opening will no longer be acceptable for portable medical products unless the device qualifies for a documented derogation. The commercial stakes are concrete:
- Without a valid CE marking under 2023/1542 and a correct economic-operator chain, product cannot be placed on the EU market.
- EU importers and distributors are auditing supplier technical files now; non-conforming packs are being refused at the border.
- Hospital tenders and procurement frameworks increasingly request battery lifecycle data, recycled-content declarations and carbon-footprint information that the regulation will soon make mandatory.
3. How Medical Device Batteries Are Classified
Obligations under 2023/1542 are tied to battery category. The same 18650 or 21700 Li-ion cell can land in a different legal category depending on pack design, weight and intended use. Getting this wrong is the most common classification error in medical projects.
Table 1. Battery categories most relevant to medical devices under Regulation (EU) 2023/1542
| Category | Typical medical examples | Why it matters |
| Portable battery (not intended for industrial use, ≤5 kg, not an LMT/EV/SLI battery) | Patient-worn monitors, pulse oximeters, ECG holters, handheld ultrasound, infusion pumps, tablet-based diagnostics | Subject to end-user removability/replaceability (Art. 11) from 18 Feb 2027; labeling and producer-responsibility rules apply. |
| Industrial battery (intended exclusively for industrial/professional use) | Stationary backup for MRI/CT control rooms, fixed surgical-suite power, >2 kWh rack-mounted UPS for hospital infrastructure | Carbon-footprint declarations and, if >2 kWh, the Battery Passport from 18 Feb 2027; recycled-content targets apply. |
| LMT battery (light means of transport) | Rare in medical; some powered mobility aids may be assessed case-by-case | Battery passport from Feb 2027; replaceable by an independent professional. |
| Implantable active medical device | Pacemakers, neurostimulators, implantable drug pumps | Fully derogated from end-user removability under Art. 11(3). |
A practical engineering rule of thumb: if a clinician or patient carries the device between rooms or wears it on the body, you are almost certainly in the portable category. If the pack is bolted into fixed hospital infrastructure and exceeds 2 kWh, treat it as industrial and plan for the Battery Passport.
4. Key Compliance Timeline
Table 2. Phased application dates relevant to medical device battery packs (consolidated 2026)
| Date | Obligation | Direct impact on medical device programs |
| 18 Feb 2024 | Regulation begins phased application; general prohibitions, labeling framework and producer registration. | EU economic operators must register in national producer-responsibility schemes. |
| 18 Feb 2027 | Art. 11: portable batteries in appliances must be readily removable and replaceable by the end user. Battery Passport mandatory for EV, LMT and industrial batteries >2 kWh. | Hard design deadline. Patient-carried devices need user-accessible battery compartments unless a derogation applies. Fixed >2 kWh hospital packs need a passport data pipeline. |
| End 2027 | Portable battery waste collection target: 63%. | Producer-responsibility fees and take-back scheme reporting ramp up. |
| 18 Aug 2028 | Recycled-content documentation required for in-scope industrial/EV/LMT batteries (methodology delegated act still being finalized at time of writing). | Supply-chain traceability for cobalt, lithium, nickel and lead must be in place. |
| End 2030 | Portable collection target: 73%; LMT collection 61% by end 2031. | Extended producer responsibility (EPR) financial contributions increase. |
| 18 Aug 2031 | Mandatory minimum recycled content: 16% cobalt, 85% lead, 6% lithium, 6% nickel in active materials. | NMC-based medical packs must plan recycled-cobalt and recycled-lithium sourcing. |
| 18 Aug 2036 | Higher recycled-content targets for cobalt, lithium and nickel. | Long-term material strategy for new platform designs. |
5. Removability and Replaceability: The Medical-Device Hot Zone
5.1 The main rule (Article 11(1))
From 18 February 2027, any operator placing on the market a product that incorporates a portable battery must ensure that the entire battery pack (not individual cells) is readily removable and replaceable by the end user at any time during the product’s lifetime. A battery is considered readily removable when it can be taken out using commercially available tools; specialized tools are allowed only if they are provided free of charge with the product. The end user is assumed to be an adult without specialized training.
5.2 Partial derogation — replacement by independent professionals (Article 11(2))
The regulation recognizes that unsealing certain professional medical devices by untrained users would create unacceptable patient-safety and infection-control risks. Under Article 11(2), reinforced by the Commission Delegated Regulation of 14 July 2026, the following products may be designed so that the battery is removable and replaceable only by independent professionals using commercially available tools:
- Professional medical imaging and radiotherapy devices, as defined in Regulation (EU) 2017/745 (MDR) — e.g. MRI, CT, angiography, linear accelerators.
- In-vitro diagnostic medical devices, as defined in Regulation (EU) 2017/746 (IVDR) — e.g. large chemistry analyzers, hematology systems.
- Appliances — including wearables — specifically designed to operate primarily in a wet environment (regular splashing, water streams or immersion) and intended to be washable or rinseable.
This is a design derogation, not an exemption from documentation. You must still document in the technical file why end-user replacement would compromise patient safety, provide a service manual, and make replacement possible for trained biomedical engineers or service technicians with standard tools.
5.3 Full derogation — no user- or professional-replacement duty (Article 11(3))
The following categories are fully derogated from the removability/replaceability obligation because a loss of continuity of power supply directly compromises patient safety:
- Implantable active medical devices (pacemakers, implantable defibrillators, neurostimulators, implantable drug pumps).
- Certain in-vitro diagnostic medical devices and surgical utensils.
- Endoscope washer-disinfectors, where opening the sealed enclosure would breach the validated reprocessing cycle.
- On-body delivery systems specifically designed for the subcutaneous administration of medicinal products, as added by the July 2026 delegated act.
5.4 Engineering consequences
- Even inside a derogation, design for serviceability: accessible connectors, documented torque values, service-compatible fasteners, and a spare-parts strategy.
- Article 11 also expects spare batteries to remain available for at least five years after the last unit of the product is placed on the market.
- Capture the derogation rationale explicitly in your risk management file (ISO 14971) and cross-reference it from the MDR/IVDR technical documentation.
6. CE Marking, Technical Documentation and Economic Operators
A battery pack placed on the EU market — whether standalone or integrated into a medical device — must bear the CE marking under 2023/1542, in addition to the CE marking of the medical device under MDR/IVDR. The obligations run along the supply chain:
- Manufacturer (the operator whose name or trademark is affixed to the pack, or who modifies it): design and manufacture in conformity with harmonized standards, compile technical documentation, issue an EU Declaration of Conformity, affix CE, and have an authorized person based in the EU.
- Importers: verify that the manufacturer has completed the conformity assessment, that the EU responsible person exists, and that labeling and traceability markings are present.
- Distributors: handle packs without compromising conformity and forward complaints to the manufacturer.
For a medical device OEM that buys a pack from a specialist battery integrator, the cleanest structure is for the pack supplier to remain the battery manufacturer, providing a full technical-file package, EU Declaration of Conformity, and test reports; the device OEM then declares the finished device under MDR/IVDR. This allocation must be written into the supply agreement.
7. Labeling and Marking Requirements
Packs placed on the EU market must carry, legibly and indelibly:
- The crossed-out wheeled bin symbol, indicating separate collection rather than municipal waste.
- Chemical symbols for Hg, Cd, Pb above the regulatory thresholds.
- Capacity marking and type/model identification for traceability.
- Instructions for consumers/professionals on removal and, where applicable, notes on professional-only replacement.
- For industrial batteries >2 kWh, a QR code linking to the Battery Passport once the passport regime applies from February 2027.
8. Carbon Footprint and Recycled Content
8.1 Carbon footprint
The regulation introduces a carbon-footprint declaration, performance and durability class for industrial and EV batteries. The Commission’s methodology delegated acts were being finalized through 2025–2026, and declarations are phased in from 2027–2028 for industrial and EV batteries. For portable medical device packs, direct mandatory carbon-footprint declarations are not the near-term pressure point — but hospital procurement and multinational tenders increasingly request a life-cycle assessment (LCA). Ask your pack supplier for an LCA report aligned with the EU Product Environmental Footprint (PEF) methodology.
8.2 Recycled content
From 18 August 2028, in-scope industrial/EV/LMT batteries must be accompanied by documentation showing the mass share of recycled cobalt, lead, lithium and nickel in the active materials. The exact calculation and verification methodology is set out in a Commission delegated act that was still in draft/notification at the time of writing (expect a notice on the EU Technical Barriers to Trade portal); the 2028 documentation duty and the 2031 minimums below are already fixed in the parent regulation. From 18 August 2031, mandatory minimums apply: 16% recycled cobalt, 85% recycled lead, 6% recycled lithium and 6% recycled nickel, rising again in 2036. For medical Li-ion packs using NMC chemistry, this means building chain-of-custody traceability for cobalt and lithium into the supplier qualification process now.
9. Does Your Medical Device Need a Battery Passport?
From 18 February 2027, every EV battery, every LMT battery and every industrial battery with a capacity greater than 2 kWh placed on the market must have a Battery Passport, accessible by QR code and containing data on composition, carbon footprint, supply-chain due diligence, state of health, and end-of-life handling. The European Commission published operational guidance for industry preparation in August 2026.
For most portable medical device batteries — handheld ultrasound, patient monitors, infusion pumps — the answer is no: they are portable batteries under 5 kg and are outside the passport’s immediate scope. The exception is fixed hospital infrastructure packs above 2 kWh (large UPS, backup for imaging suites), which should be classified as industrial and engineered with a passport data pipeline. If you are unsure which side of the line your product falls, document the classification rationale and confirm with your notified body.
10. Interaction with MDR 2017/745 and IVDR 2017/746
The battery is a critical safety component of a medical device. Under MDR/IVDR it already contributes to compliance with general safety and performance requirements, to electrical safety (IEC 60601-1), EMC (IEC 60601-1-2) and to the clinical/electrical risk file. Regulation 2023/1542 layers circular-economy and market-surveillance obligations on top:
- The device’s MDR technical file can reference the battery’s IEC 62133-2 safety file and UN 38.3 transport summary.
- Labeling on the device and on the pack must not conflict; patient instructions must cover safe battery removal and disposal.
- Post-market surveillance under MDR and market surveillance under 2023/1542 must share the same complaint-handling and recall channels.
11. Compliance Roadmap for Medical Device OEMs
Table 3. Eight-step engineering and regulatory checklist
| Step | Action | Target |
| 1 | Classify every battery SKU (portable / industrial >2 kWh / implantable / LMT). | Q1 2027 design freeze |
| 2 | Map Article 11(2)/(3) derogations and document the patient-safety rationale in the ISO 14971 risk file. | Before 18 Feb 2027 |
| 3 | Verify pack-supplier files: EU DoC, IEC 62133-2, UN 38.3, CB report, ISO 13485. | Before series production |
| 4 | Audit labels: crossed-out wheeled bin, Hg/Cd/Pb, capacity, model ID, QR where applicable. | Next label revision |
| 5 | Appoint an EU authorized representative; register in national EPR/producer registers. | Before first EU shipment |
| 6 | Redesign battery compartments for end-user (or professional) removal; secure 5-year spare-parts supply. | Before 18 Feb 2027 |
| 7 | Build recycled-content chain-of-custody documentation and LCA/carbon-footprint data. | Ready by Aug 2028 |
| 8 | For industrial packs >2 kWh, build the Battery Passport data pipeline and QR-code label. | Ready by 18 Feb 2027 |
12. Field Notes: Three Missteps We Saw in 2026 EU Compliance Programs
In 2026 we supported several European medical-device customers through their 2027-readiness reviews. Three issues recurred often enough to be worth flagging before you start your own redesign.
- Misstep 1 — treating every patient device as automatically user-replaceable. A mid-size ultrasound customer assumed their handheld cart system would fall under the professional-imaging derogation, only to learn that the derogation applies to *professional medical imaging and radiotherapy devices* as defined in MDR; a cart-based, portable diagnostic system sold to general practices and clinics is typically still classified as portable. The fix was a 6-week battery-compartment redesign, not a paper justification.
- Misstep 2 — assuming a glued IP-sealed pack cannot meet removability. An IP54 patient monitor team believed a sealed pack was the only way to hold the ingress rating. In practice, a gasketed battery door with a captive screw and a commercially available Torx bit (provided free of charge) met both the IP54 target and Article 11. Do not give up on removability before testing a gasketed-door concept.
- Misstep 3 — leaving the EU responsible person appointment to the last month. National producer-register onboarding and EPR contract negotiations typically take 10–14 weeks across multiple EU member states. Customers who started this in Q4 2026 were still waiting on registration confirmations at press time.
13. What to Look for in a Compliant Medical Battery Pack Supplier
Because the battery manufacturer bears direct legal responsibility under 2023/1542, selecting a pack partner who already holds the right certifications and documentation is the single fastest way to de-risk your EU launch. The table below sets out the capabilities procurement and engineering teams should score every supplier against.
Table 4. Compliance capability matrix for medical battery pack suppliers
| Capability | What to require | Why it matters under 2023/1542 |
| Quality system | ISO 13485 certification for medical design and manufacturing. | Required for any medical supply chain; supports MDR/IVDR technical files. |
| Cell/pack safety | IEC 62133-2 (portable sealed secondary lithium cells), UL 2054 / UL 1973 where relevant, CB scheme reports. | Presumption of conformity with battery safety; required for CE under 2023/1542. |
| Transport | UN 38.3 test summaries, IATA-compliant packing instructions. | Mandatory for shipping Li-ion packs; importer audits will ask for it. |
| Environmental compliance | CE marking under 2023/1542, RoHS, REACH, conflict-minerals due-diligence report. | Prevents border rejection and tender disqualification. |
| Smart BMS | Battery Management System with SMBus / I²C communication, fuel gauging, state-of-health and fault logging. | Feeds Battery Passport data, service diagnostics and device-level safety. |
| Traceability | Cell-level lot traceability; chain-of-custody for recycled cobalt/lithium. | Prepares for the 2028 documentation duty and 2031 minimums. |
| Technical file package | EU Declaration of Conformity, risk file aligned to ISO 14971, LCA data on request. | Lets the OEM plug the pack directly into its MDR/IVDR file. |
| OEM customization | Custom pack geometry, connectors, communication protocols, IP-rated sealed enclosures, smart BMS firmware. | Lets you meet Art. 11 removability or professional-service design without a custom cell program. |
| After-sales support | Minimum 5-year spare-battery availability, service documentation, field-failure analysis. | Aligns with Article 11 spare-parts expectation and MDR PMS. |
About TEFOO
TEFOO is an OEM/ODM manufacturer of medical and industrial Li-ion battery packs, with ISO 13485-certified production. The company’s packs ship with IEC 62133-2 and UN 38.3 reports and integrate a smart BMS with SMBus communication; the team supports medical device customers on pack customization, technical-file packaging and EU Battery Regulation readiness. This section is provided for identification purposes and does not constitute an endorsement or a solicitation.
14. Frequently Asked Questions
Q1. Does a patient-worn pulse oximeter need a user-replaceable battery after February 2027?
If the pack is classified as a portable battery and the device does not fall within an Article 11(2) or (3) derogation, yes. Most ambulatory patient devices (oximeters, ECG holters, handheld monitors) fall under the main rule and should be designed with a user-accessible compartment using commercially available tools.
Q2. Are implantable pacemaker batteries exempt?
Yes. Implantable active medical devices are fully derogated under Article 11(3) because a break in power continuity directly compromises patient safety. They remain, of course, subject to medical-device regulation and to transport and end-of-life requirements.
Q3. Does my portable handheld ultrasound need a Battery Passport?
No. The Battery Passport from 18 February 2027 applies to EV batteries, LMT batteries and industrial batteries above 2 kWh. A hand-carried ultrasound pack is a portable battery and is outside the passport’s immediate scope. Fixed hospital imaging backup packs above 2 kWh, however, should be treated as industrial and planned for the passport.
Q4. How are MRI and CT scanner batteries treated?
Professional medical imaging and radiotherapy devices are explicitly named in Article 11(2): the pack must be removable and replaceable by independent professionals (trained service technicians) using commercially available tools, rather than by the end user. Document the rationale and provide a service manual. Be careful: this derogation is scoped to devices that are themselves professional imaging/radiotherapy equipment under MDR — a portable diagnostic ultrasound sold to general practice does not qualify.
Q5. When does recycled-content compliance actually bite?
Documentation of recycled cobalt, lithium, nickel and lead starts 18 August 2028; the mandatory minimums — 16% recycled cobalt, 6% recycled lithium, 6% recycled nickel, 85% recycled lead — apply from 18 August 2031, with higher targets in 2036. The exact calculation methodology is being finalized by Commission delegated act; build chain-of-custody traceability with your cell suppliers now so you are ready whichever methodology is adopted.
Q6. Who is the legal battery manufacturer — us (the device OEM) or the pack supplier?
Whichever operator affixes its name or trademark to the pack, or materially modifies it, is the battery manufacturer. In most medical programs, the specialist pack integrator remains the battery manufacturer and provides the EU Declaration of Conformity and technical file; the device OEM declares the finished device under MDR/IVDR. Allocate these roles explicitly in your supply agreement.
Q7. A wheeled, cart-based ultrasound system — is it portable or industrial?
There is no automatic rule based on wheels. Classification turns on the intended use, where it is used, and whether the pack is ≤5 kg and not intended exclusively for industrial use. A compact cart ultrasound that a clinician moves between wards in a clinic is usually treated as portable; a fixed, high-end imaging system bolted into a radiology suite is closer to professional medical imaging under Article 11(2). Document the classification rationale in the technical file and have it reviewed with your notified body — do not rely on the pack’s weight alone.
15. Conclusion
Regulation (EU) 2023/1542 is a supply-chain-wide, circular-economy regulation, not a paperwork exercise. For medical device OEMs, the two priorities before 18 February 2027 are (1) correctly classifying each battery SKU and documenting the Article 11 derogations where they apply, and (2) redesigning portable packs for end-user or professional serviceability. The later 2028–2036 obligations around recycled content and Battery Passport data require supply-chain traceability that should be scoped into today’s supplier qualification.
References and Further Reading
• Regulation (EU) 2023/1542 on batteries and waste batteries — consolidated text, EUR-Lex 32023R1542.
