1) Three models – and why classification determines everything
Reusable medical devices are reprocessed in Germany in accordance with the MPBetreibV and the KRINKO–BfArM recommendation, which is regarded as the recognised state of the art in science and technology.
In CE remanufacturing under Article 17(2) MDR, ownership of the single-use device transfers to the remanufacturer. Legally, the remanufacturer becomes the manufacturer, including all associated obligations such as a quality management system in line with EN ISO 13485, technical documentation under the MDR, risk management, market surveillance, and liability under product liability law. The device is subsequently re-placed on the market bearing a CE marking.
By contrast, CS reprocessing under Article 17(3) to (5) MDR is structured as a service for the healthcare institution: ownership of the device remains with the institution, while reprocessing is carried out in accordance with Implementing Regulation (EU) 2020/1207 (Common Specifications) in conjunction with Section 9 MPBetreibV. These requirements include, among other things, validated reprocessing procedures, a quality management system in accordance with ISO 13485, product registers, and clear documentation, testing and monitoring obligations. Formally, certification by a Notified Body is required. Currently, CS reprocessing in Germany is tolerated by authorities, as no appropriately designated Notified Bodies are yet available.
2) Clear distinction: not everything qualifies as “reprocessing under Article 17”
Article 97 MDR (Other non-compliance) governs the actions taken by authorities where deviations from MDR requirements are identified, provided there is no unacceptable risk to patients. In such cases, measures to restore compliance are ordered and monitored. This approach applies, for example, in situations where no appropriately designated Notified Body is available for CS reprocessing under Implementing Regulation (EU) 2020/1207.
3) Requirement before starting: notification under Section 4 MPDG
The notification obligation applies, among others, to external remanufacturers, healthcare institutions that carry out CS reprocessing, and healthcare institutions that commission such reprocessing. Notification must be submitted before activities commence, include the relevant address details, and be transmitted via DMIDS. Important: any changes must be reported without delay.
4) Requirement during operation: report when it matters
Serious incidents must be reported without delay in accordance with Section 3 MPAMIV and Article 87 MDR. Depending on the case, reporting deadlines range from 2 to 15 days, for example where an incident has led, or could have led, to death, serious deterioration in health, or represents a serious threat to public health. This obligation applies to operators, users (formerly “Anwender”), and healthcare institutions.
In summary:
If remanufacturing or reprocessing single-use devices is planned (or already taking place), the following questions are essential:
- Which model applies (reusable vs CE remanufacturing vs CS reprocessing)?
- Who holds which legal role (operator/manufacturer/service provider)?
- Are notification, documentation and reporting processes structured in a way that is audit-proof?
Depending on the model, roles, obligations and liability are clearly assigned. This is precisely what ensures safety for patients, teams and processes.
Do you have any further questions about the reprocessing of single-use products? Please feel free to contact our customer service team:
