- Environmental law Overview: Ongoing initiatives Regulations for the MedTech industry

This fact sheet provides an overview of selected ongoing initiatives that have not yet been finalized in the form of a legal act. This is intended to highlight upcoming developments in advance.

Amendment of the Waste Framework Directive - Extended producer responsibility for textiles

On 5 July 2023, the EU Commission presented a proposal for the revision of the EU Waste Framework Directive 2008/98/EC, which, in Art. 22a et seq., includes the introduction of extended producer responsibility for textiles.

The material scope of Annex I covers household textiles, clothing textiles and clothing accessories as well as footwear, clothing and clothing accessories, mainly made of materials other than textiles, by reference to specific CN codes. Medical devices in these areas are neither explicitly listed nor excluded, meaning that medical devices could also be affected.

In personal terms, the so-called producer is at the center of the regulation. In summary, this typically includes the producer established in a Member State, quasi-producers, resellers under their own name, and importers, as well as distance sellers who sell directly to end consumers. Excluded are particularly microenterprises, bespoke tailors, and second-hand dealers.

In terms of content, producers will need to register in each Member State where they place affected products on the market and will be required to bear the financial and organizational burdens of the collection, take-back, and further handling of used textiles through producer responsibility organizations. In addition, consumer information, documentation, and reporting obligations are also expected to be introduced.

The proposal also contains clauses to protect collection by social enterprises.

The trilogue negotiations have been successfully concluded and the textExterner Link. Öffnet im neuen Fenster/Tab. of the provisional agreement must now be adopted by Parliament. This is currently scheduled for 6 October 2025, meaning that the national implementation regulations would have to come into force in mid/end 2027.

Right to repair

Directive (EU) 2024/1799 on the right to repair (often referred to as "R2R") has now been adopted. The new requirements must be transposed into national law and applied by 31 July 2026.
The Directive is intended to apply to certain goods purchased by consumers, i.e. in the B2C sector. The product groups covered are listed in an Annex to the draft. These are the following products for which eco-design requirements are defined:

• Washing machines and washer-dryers
• Dishwasher
• Refrigerator cabinets
• Electronic displays
• Welding equipment
• Hoover
• Server and data storage products
• and in future also mobile phones, cordless phones and tablets
• Domestic tumble dryers and
• Goods containing batteries for light means of transport (such as e-bikes and e-scooters)

The product groups may be expanded in the future. However, this also means that the actual/new right to repair, according to the current draft, will not cover medical devices, as there are no such eco-design requirements for them, and they are not listed in the Annex of the draft directive.

The core of the proposedDirective is a newly created legal obligation to repair the covered goods free of charge or for a fee when a repair is possible. The possibility of offering repairs for a fee only is provided by the Directive, as the defect could also have been caused by the end customer. In particular, in cases of defects caused by the customer, it would be unfair and financially unpredictable to offer free repairs.

According to the proposed concept, the manufacturer is primarily responsible for repairs, with the explicit permission to hire subcontractors. If the manufacturer is based outside the EU, the repair obligation will fall on their authorized representative. If there is no authorized representative, the repair obligation will instead lie with the importer of the product. In the absence of an importer, the retailer may also be responsible for the repair.

This detailed and extensive Directive is designed to ensure that consumers have a liable party for repair obligations within the EU.
A form for repair information is provided. However, unlike in earlier drafts of the legislation, the use of this form is no longer mandatory. As an incentive, using the form is presumed to fulfill certain EU legal information requirements.

The new directive is also set to modify the law on sales contracts. These changes will apply to all products, including medical devices. While the buyer's right to choose between the two types of remedy (repair or replacement) in the context of warranty claims will remain, new provisions are planned to encourage the buyer to opt for repair. As an incentive for choosing repair, the warranty period for the buyer will be extended by one year. Assuming the current two-year warranty period under German sales law, this will result in an extension of the warranty period by 50%, leading to a total of three years if the buyer opts for repair.

In addition, a new obligation to provide information will be introduced. Before carrying out the remedy, the seller must explicitly inform the consumer (as the buyer) of their right to choose between repair and replacement, and about the extension of the warranty period in the event of choosing repair. These changes are of high practical relevance.

It is also worth noting that the Right to Repair (R2R) Directive will be included in the annex of the European Representative Actions Directive. This means that the new right to repair will also be subject to representative (or collective) actions. As a result, it will be possible for numerous consumers to jointly bring claims against the obligated party—most commonly the manufacturer—in the form of (potentially EU-wide) collective legal proceedings

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.