Reprocessed Single Use Device

The EU Medical Device Regulation (MDR) introduced stricter rules and clearer responsibilities for all actors involved in the life cycle of medical devices. One area that raises particular questions is the reprocessing of Single Use Devices (SUDs) – a practice that seems contradictory at first but is permitted under specific conditions.

But how are reprocessed SUDs registered in EUDAMED? And what does this mean for manufacturers, reprocessors, and healthcare institutions?

What is a Reprocessed Single Use Device?

A Single Use Device (SUD) is intended by the manufacturer to be used once, for one patient, during a single procedure. Under MDR, such products may be reprocessed and reused only if national laws allow it and strict requirements are fulfilled.

Responsibility for reprocessed SUDs lies with either the original manufacturer or a qualified reprocessor, who must comply with all relevant MDR obligations—such as clinical evaluation, quality management system, and UDI.

How to Declare It in EUDAMED

When registering a reprocessed SUD in EUDAMED, the following fields must be filled out accurately:

• “Labelled as Single Use Device” = YES
  → The original label on the device indicated single use only.

• “Reprocessed Single Use Device” = YES
  → The product has undergone a validated reprocessing procedure and is being placed on the market again.

These fields are critical for compliance and traceability within the UDI database.

✅ When Is a New UDI-DI Required?

According to Annex VI, Part C, Section 3.9 of the MDR, a new UDI-DI is required if any of the following apply:

1. The product is now labelled as reprocessed
2. The product has been repackaged and sterilized
3. Sterilization prior to use is now required

👉 Even if the device itself hasn’t changed, changes to labeling, packaging, or sterilization can trigger the need for a new UDI-DI.

🏥 Exception: Reprocessing Within Health Institutions

Under Article 17(3) MDR, EU Member States may allow exceptions for hospitals and healthcare institutions:

• If a health institution reprocesses a single use device for its own use, it may be exempt from certain manufacturer obligations – including UDI requirements
• This only applies if the device is not placed on the market, and is used internally within the institution

⚠️ This exemption does not apply to commercial reprocessors or devices intended for distribution beyond the institution.

Typical EUDAMED Field Values for Reprocessed SUDs