EU Battery Regulation: Why Medical Devices Are Not Broadly Exempt

From February 18, 2027, Article 11 of the Battery Regulation (EU) 2023/1542 applies. Anyone placing a product with an incorporated portable battery on the market must ensure that the end user can readily remove and replace the battery at any time during the product's lifetime. In principle, that includes medical devices. Exemptions exist, but they are tied to device groups and conditions, not to the sector as a whole.

What does Article 11 require from February 2027?

The general rule sits in Article 11(1). "Readily" means with commercially available tools, without specialized tools unless they are provided free of charge with the product, without proprietary tools, thermal energy or solvents. The obligation covers the whole battery, not individual cells.

Four further obligations tend to get lost in the debate about exemptions:

• Instructions: instructions and safety information on removing and replacing the battery accompany the product and remain available online on a publicly accessible website (Article 11(1)).
• Compatibility: a battery counts as replaceable only if a compatible battery can take its place without affecting the functioning, performance or safety of the device (Article 11(6)).
• Spare parts: replacement batteries must remain available for at least five years after the last unit of the model reaches the market, at a reasonable and non-discriminatory price, for independent professionals and end users (Article 11(7)).
• Software: it must not be used to hinder replacement with a compatible battery (Article 11(8)).

Where does the idea that medical devices are exempt come from?

The statement "medical devices are exempt" appears in articles, in discussions and now in automated search engine summaries as well. It has a true core. For some medical devices, the Commission guidelines consider the full derogation relevant, for example for active implants and hearing aids. As a statement about the whole sector, it does not hold.

The partial exemption in Article 11(2) names only certain medical device groups. Even there, it does not lift replaceability, only replacement by a layperson: the battery must then be removable and replaceable by independent professionals. Everything that neither falls under Article 11(2) nor meets the conditions of Article 11(3) is subject to the general rule.

Which medical devices fall under which rule?

The full derogation in Article 11(3) has two conditions that must be met together: continuity of power supply is necessary, and a permanent connection to the battery is required to ensure the safety of the user and the appliance. The second variant, data integrity, is open only to products whose main function is collecting and supplying data.

The guidelines give examples; they do not decide individual cases. They state that they are not legally binding and that the final interpretation rests with the Court of Justice of the EU. Classification therefore remains the manufacturer's task, product by product, with a rationale that holds up in market surveillance.

What changed in fall 2026?

The Official Journal carried Delegated Regulation (EU) 2026/1770 on October 22, 2026. It enters into force on the twentieth day after publication, November 11, 2026. It replaces Article 11(2) and extends the partial exemption from two cases to eight. Three of them are new for life sciences.

• Wearables (point (c)): wearable devices for which user access to the battery may compromise safety, durability or water resistance, and which are too small for a safe replacement or rely on a compact, sealed enclosure for protection against dust and shock.
• On-body systems (point (g)): on-body delivery systems specifically designed for the subcutaneous administration of medicinal products.
• Explosive atmospheres (point (f)): products within the scope of Directive 2014/34/EU on equipment for potentially explosive atmospheres.

All three apply only where the exemption is required to ensure the safety of the user and the appliance. For imaging, radiotherapy and IVD (point (b)), this condition does not apply. The Commission justifies the inclusion of on-body systems by the risk that removal by the end user could lead to incorrect administration of medication (recital 7).

Why does this concern pharmaceutical companies too?

Article 11 addresses whoever places the product with the incorporated battery on the market. Where the medicinal product and the delivery device form a single integral product intended exclusively for use in that combination and not reusable, it is governed by medicinal product law (MDR Article 1(9)). It then reaches the market as a medicinal product. There are therefore good arguments that the Article 11 obligations lie with the pharmaceutical company in that situation, not with the device maker.

The new exemption does not shift this responsibility; it only relaxes who must be able to replace the battery. For on-body systems too, independent professionals must be able to remove and replace the battery, and the exemption applies only where required for safety. Whether a single-use system meets this requirement or falls under Article 11(3) is not expressly addressed by either the regulation or the guidelines. That question is open.

What applies to products in stock?

Article 11 covers every product put on the EU market from February 18, 2027. According to the Commission's Blue Guide, placing on the market refers to each individual product, not to a model. Devices manufactured before the cut-off date but made available on the Union market for the first time afterward, meaning they pass from the manufacturer or importer to the first recipient, therefore fall under the new rule. Units already passed to distributors earlier have already been placed on the market. For the spare part obligation, the guidelines take the view that earlier products are outside its scope.

How should manufacturers proceed now?

1. Take stock: all products with a portable battery that will still reach the market from February 18, 2027.
2. Classify: general rule, partial exemption under Article 11(2) with the point and the condition met, or full derogation under Article 11(3) with both conditions. The rationale belongs in the product documentation.
3. Check the obligations: design, instructions supplied with the product and published online, five years of spare part supply, software.
4. Align with the MDR: a design change for replaceability is a change to the medical device and runs through MDR or IVDR change control. Depending on class and procedure, the notified body must approve it, for example under MDR Annex IX Section 4.10 where it could affect safety, performance or the prescribed conditions of use. For legacy devices in transition under MDR Article 120, check whether the change affects the transitional status. For integral drug-device combination products, it must also be assessed within the marketing authorization of the medicinal product.

Recital 38 of the Battery Regulation expressly leaves the safety and maintenance requirements for imaging, radiotherapy and IVD unaffected. According to the guidelines, specific safety rules on battery removal in other EU legislation also take precedence. Where such a rule applies to a product, it belongs in the same rationale.

Image notice: The images in this article were generated using artificial intelligence. They do not depict real people, places, or events.