MedTech Europe Calls Against Reusability by Default Under MDR Article 17

MedTech Europe has published a position paper titled “Single-use by design: why reusability should not be the regulatory default under MDR Article 17.”

The document is dated 9 September 2026 and is presented as a supplement to MedTech Europe’s broader position on the MDR/IVDR revision.

Background

The paper addresses the European Commission’s proposal to revise Article 17 of Regulation (EU) 2017/745, the Medical Devices Regulation, MDR.

According to MedTech Europe, the proposal would significantly change the EU framework for single-use medical devices by requiring manufacturers to justify why a single-use device cannot be reused. In the absence of such justification, the device would become reusable by default and require reprocessing instructions.

MedTech Europe’s Position

MedTech Europe states that the medical technology sector supports the Commission’s objectives of creating a more harmonised EU framework, reducing fragmentation between Member States and ensuring that operators who fully refurbish single-use devices assume manufacturer responsibility.

The organisation also recognises the importance of sustainability and notes that manufacturers continue to innovate in reusable technologies, material optimisation, recycling, packaging reduction and lifecycle-oriented product development.

However, MedTech Europe does not support reversing the regulatory default. It argues that reprocessing should be allowed where it is scientifically shown to be safe, but that single-use devices should not become reusable by default.

Definitions Used in the Paper

The paper distinguishes between single-use devices, reusable medical devices and reprocessing.

A single-use device is described as a device intended by the manufacturer to be used on one individual during a single procedure or episode of use only. A reusable device is designed, validated and intended to undergo cleaning, disinfection, sterilisation, maintenance and repeated use while maintaining safety and performance. Reprocessing is described as a process performed on a used device to allow safe reuse.

Single-Use Design as a Risk-Based Decision

MedTech Europe argues that single-use designation is not arbitrary.

The paper states that whether a device is single-use or reusable forms part of the manufacturer’s intended purpose and results from lifecycle risk-management processes under MDR requirements and harmonised standards, including EN ISO 14971.

The paper also notes that single-use devices may be selected based on clinical application, material characteristics, cleaning and sterilisation feasibility, infection prevention, functional performance, usability, traceability and healthcare system infrastructure.

Commission Proposal

The paper states that the Commission proposal would introduce several changes to Article 17, including:

• requiring manufacturers of single-use devices to justify why they cannot be reused;

• requiring reprocessing instructions for single-use devices that become reusable;

• allowing single-use devices and devices that can no longer be reused to be fully refurbished.

MedTech Europe acknowledges that these proposed changes are intended to harmonise the EU framework, reduce fragmentation and promote waste reduction.

Key Concerns

MedTech Europe identifies several concerns with the proposed approach.

The organisation argues that the proposed justification requirement would create a significant new regulatory burden, while the level of evidence required remains unclear. It also questions how manufacturers would prove that a device cannot be reused, especially where the device is plainly unsuitable for reuse.

The paper also states that single-use devices are specifically designed, validated and clinically assessed for one-time use, and that reprocessing would introduce variables that cannot be fully standardised across devices, healthcare settings or Member States.

MedTech Europe Recommendations

MedTech Europe recommends keeping the Commission’s objective of clarifying responsibilities for reprocessing and full refurbishment, but removing the requirement for manufacturers to justify why a single-use device cannot be reused.

Its proposed approach includes:

• reprocessing of single-use devices should not be the regulatory default;

• intended purpose should remain determined by the manufacturer based on clinical risk-benefit and the state of the art in medicine;

• no additional justification should be required for single-use designation beyond existing MDR requirements;

• any entity reprocessing a single-use device should assume manufacturer-equivalent responsibilities and become the full refurbisher.

Lifecycle Risk Management

The paper frames the single-use design principle as a patient-safety safeguard.

MedTech Europe argues that many single-use devices are engineered for one clinical application, with material selection, sterility assurance, packaging, usability and performance characteristics optimised for that intended use.

For safe reuse, devices must be specifically designed and validated for repeated processing cycles, including material compatibility, cleanability, resistance to disinfection and sterilisation, functional durability and maintenance of safety and performance over the validated lifetime.

Reprocessing Risks

The paper highlights several risks associated with reprocessing.

These may include microbial contamination, residual biological material, endotoxins, biofilm formation, loss of barrier integrity, material fatigue, coating deterioration, altered biocompatibility and progressive degradation of device performance.

MedTech Europe also notes that certain technologies present elevated risks, including active implantable devices, blood-contacting devices, software-enabled systems, devices with inaccessible internal channels, coated or porous materials, and technologies intended for contact with the central nervous system.

Legal Clarity, Traceability and Liability

The paper argues that the proposal introduces legal uncertainty because it does not define the level of evidence, scope or scientific standard needed to justify single-use designation.

MedTech Europe states that there is a validated framework for demonstrating safe reuse, such as the ISO 17664 series, but no equivalent framework for demonstrating non-reusability.

The paper also highlights operational challenges around traceability, including tracking device history, maintaining UDI continuity, documenting transport and storage conditions, ensuring relabelling accuracy and linking adverse events to the correct responsible entity.

Innovation and International Divergence

MedTech Europe states that no major international regulatory jurisdiction currently applies a comparable “reusable by default” regulatory presumption.

According to the paper, the proposal could place the EU in a unique regulatory position, diverging from the United States, Japan, the United Kingdom, China and other major global markets.

The organisation also warns that the approach could create open-ended liability exposure, regulatory uncertainty, longer development timelines, higher regulatory costs and possible delays or withdrawals of products from the EU market, especially for SMEs.

Sustainability and Circularity

MedTech Europe supports sustainable healthcare solutions but argues that sustainability should not be pursued through a generalised “reusable by default” approach.

The paper notes that both single-use and reusable devices have sustainability costs, including water, energy, chemical and packaging use in reprocessing. It recommends evidence-based, proportionate and clinically appropriate measures that preserve patient safety, performance, usability and healthcare efficiency.

Examples of Devices With Elevated Reprocessing Complexity

The annex provides non-exhaustive examples of single-use devices with elevated reprocessing complexity.

These include active implantable devices, devices with inaccessible internal channels or complex geometries, coated, composite or porous materials, and software-enabled or electronic systems.

For example, active implantable technologies may involve software dependencies, battery integrity, calibration, sensing performance and long-term reliability issues that are not externally visible.

Impact on Medical Device Manufacturers

For medical device manufacturers, full refurbishers, healthcare institutions, notified bodies and regulators, the paper is relevant because it addresses a potentially significant change to the EU framework for single-use devices.

Stakeholders should pay particular attention to:

• proposed changes to MDR Article 17;

• single-use device justification requirements;

• reprocessing instructions;

• full refurbishment responsibilities;

• manufacturer intended purpose;

• lifecycle risk management;

• cleaning, disinfection and sterilisation validation;

• traceability and UDI continuity;

• post-market surveillance and vigilance;

• liability allocation between lifecycle actors;

• sustainability and circularity measures;

• potential impact on SMEs and EU competitiveness.

For companies placing medical devices on the EU market, the key message is that MedTech Europe supports safe, evidence-based reprocessing, but opposes making reusability the default regulatory assumption for single-use devices.