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Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR


Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR

"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning, disinfection, sterilization, and related processes, along with the testing and restoration of the device's technical and functional integrity. The European Union Medical Device Regulation (EU MDR) 2017/745 specifically defines "reprocessing" in the context of single-use devices (SUDs). Reprocessing for reusable devices involves suitable processes, such as cleaning, disinfection, packaging, and validated methods of resterilization.


The EU MDR, outlined in Article 17, provides provisions for the reprocessing of SUDs where authorized by Member States at a national level. While single-use devices are designed by manufacturers for one-time use, reusable devices are intended for multiple uses after undergoing appropriate procedures like cleaning, disinfection, and sterilization. Consequently, the EU MDR sets distinct responsibilities and requirements for reprocessing single-use and reusable devices.


Regulation across European Countries


Regulations regarding reprocessed devices vary across European countries, with national laws dictating the placement of these devices within specific regions. EU countries may introduce or maintain procedures that are more stringent than those stated in the MDR. They are obligated to notify the European Commission of their national provisions on reprocessing of single-use devices as per Article 17(3) of the MDR and any restrictions or prohibitions related to such reprocessing under Article 17(9) of the MDR.


Certain EU and EEA countries do not permit the reprocessing of single-use devices within their territories. In contrast, others authorize reprocessing with varying degrees of applicability and may define restrictions or prohibitions at the national level.


  •  Austria (AT)

  •  Cyprus (CY)

  •  Czech Republic (CZ)

  •  Denmark (DK)

  •  Estonia (EE)

  •  Finland (FI)

  •  France (FR)

  •  Greece (EL)

  •  Italy (IT)

  •  Latvia (LV)

  •  Lithuania (LT)

  •  Malta (MT)

  •  Norway (NO)

  •  Romania (RO)

  •  Slovakia (SK)

The list of EU countries that authorise reprocessing of single-use devices on their territory are summarized in below table. It also specifies if other options from Article 17 of EU MDR are applicable as well as if restrictions and prohibitions are defined at the national level for the reprocessing of single-use devices.

​COUNTRY

OPTIONS, RESTRICTIONS AND PROHIBITIONS

OPTIONS, RESTRICTIONS AND PROHIBITIONS

OPTIONS, RESTRICTIONS AND PROHIBITIONS

OPTIONS, RESTRICTIONS AND PROHIBITIONS

17(2) Manufacturer obligations

17(3) Common Specifications

17(4) Outsourcing

17(9) Restriction and prohibitions

Belgium (BE)

Permitted


Permitted


Permitted


Established

Croatia (HR)



Not Permitted


Permitted


Permitted


Established

Germany (DE)



​Permitted


Permitted


Permitted


Established

​Ireland (IE)

Permitted

Not Permitted

Not Permitted

Not Established

The Netherlands (NL)

Permitted

Not Permitted

Not Permitted

Not Established

​Sweden (SE)

Not Permitted

Permitted

Permitted

Established

Regulation of Reprocessed Devices under EU MDR


Under Article 17 of the MDR, reprocessing of single-use devices is allowed only if permitted by national law. Reprocessors, whether natural or legal persons or companies, are considered manufacturers of the reprocessed devices rather than the original device manufacturers if reprocessing is permitted. They must adhere to the general obligations specified in Article 10 of the EU MDR. Key requirements include ensuring that reprocessed devices' performance and safety are equivalent to the original devices and compliance with EU MDR requirements. Reprocessors must also establish and validate reprocessing methods, maintain quality management systems, monitor reprocessing cycles, and ensure traceability.


Reprocessing by Health Institutions for Internal Use


Health institutions that use single-use devices may choose to reprocess them for internal use or outsource reprocessing to external reprocessors. In cases involving external reprocessors, both parties must establish a clear contractual agreement that defines their respective roles, responsibilities, and transition procedures between external reprocessors.


The contract should comprehensively outline the distribution of tasks, obligations, and responsibilities between the two parties involved. It should also address the procedures for transitioning from one external reprocessor to another and delineate the responsibilities of the external reprocessor who is a party to the contract.


These contracts should also address personnel qualifications, reprocessing procedures, information exchange, and the compatibility of quality management systems.


EU countries may decide not to apply all manufacturer obligations under the MDR to single- use devices reprocessed and used within health institutions. However, health institutions must provide substantial evidence that the reprocessed devices maintain safety and performance equivalent to the original devices and comply with requirements related to risk management, procedure validation, quality management, product release and performance testing, incident reporting, and traceability.


EU countries have the option to apply the same regulations that govern health institutions to single-use devices reprocessed by external reprocessors, provided that the reprocessing is carried out at the request of a health institution and the reprocessed device is subsequently returned to that institution. Manufacturers are responsible for specifying the intended use of their devices, whether they are designed for single use or reusable. Health institutions should engage in the reprocessing of single-use devices (both sterile and non-sterile) only when explicitly instructed to do so by the manufacturer and when the original equipment manufacturer (OEM) provides reprocessing guidelines along with the device.


These reprocessing instructions should comprehensively outline the procedures necessary for reuse, covering aspects like cleaning, disinfection, packaging, and any limitations on the number of reuse cycles. If reprocessing activities deviate from the OEM's instructions, the organization undertaking these activities assumes the role of a reprocessor and legal manufacturer, as stipulated by Article 17 of the MDR.


Personnel Requirements for Reprocessing of SUDs


Reprocessing facilities must guarantee an adequate staffing of personnel possessing pertinent expertise and comprehensive professional training to uphold the reprocessing's quality. These individuals should have well-defined roles and responsibilities documented in writing. Within the reprocessing team, one or more individuals with substantial experience, qualifications in reprocessing, incident reporting proficiency, and critical analysis skills must be appointed as the designated Person Responsible for Reprocessing. This responsible individual should be consistently available during the reprocessor's operational hours. Furthermore, they are also accountable for the development and oversight of technical documentation.


Premises and Equipment Requirements


The facility and its equipment must align with the specific type of single-use devices being reprocessed, the various stages within the reprocessing cycle, and the quantity of reprocessing steps involved. This includes the meticulous control and periodic monitoring of the premises' surfaces and environmental conditions, encompassing aspects such as temperature, humidity, airborne particles (both viable and non-viable), as well as water and other gases and fluids. These measures ensure that the microbiological and physical attributes of these elements meet the necessary standards for effective reprocessing.


The equipment must also undergo routine maintenance, performance assessments, and calibrations in accordance with widely accepted state-of-the-art practices as outlined in the manufacturer's instructions. Furthermore, the equipment should undergo validation and, where applicable, periodic revalidation to confirm its suitability for its intended purpose.


Quality Management Systems and Audit requirements for Reprocessing of SUD


Reprocessors shall establish, document, implement, and maintain a QMS for the reprocessing activities in compliance with Regulation (EU) 2017/745. The QMS shall cover all steps of reprocessing and shall address at least the following aspects:


  • Strategy for regulatory compliance

  • Procedures for each step of the reprocessing cycle

  • Description of the responsibilities and tasks, qualification, training of the personnel involved in reprocessing

  • Description of the premises

  • Establishment and maintenance of the technical documentation

  • Control of documents, records and communications concerning the reprocessing activities

  • Incident reporting and management of corrective and preventive actions and verification of their effectiveness

  • Risk management

  • Traceability system, including procedures for disposing or returning to the external reprocessor reprocessed sud that do not belong to the health institution

  • Internal and external audits

  • Contract conditions with external entities participating in the reprocessing activities

Reprocessors shall undertake at least one annual independent external audit of the reprocessing activities. The audit report shall be made available to the notified body and to the competent authority of the member state where the reprocessor is established. The reprocessing processes and the QMS shall be revised, as needed, on the basis of the results of the independent external audit. The audit report and the documentation related to the eventual follow up actions shall be kept for five years.


Technical Documentation Requirements for Reprocessed SUDs


Reprocessors shall also have a technical documentation specific to each model of single-use device, manufactured by the same manufacturer, as identified by its device identifier in the Unique Device Identification system (‘UDI-DI’). The technical documentation and all records regarding all steps of the reprocessing cycle shall be kept for 10 years after the last reuse of a single-use device. The same shall be made available to the notified body and to the competent authority of the Member State where the reprocessor is established.


The technical documentation on its reprocessing activities which shall include:


  • The procedures for controlling and periodically monitoring premises and equipment used in reprocessing

  • Any decision concerning the ability or lack of ability to reprocess a type of single-use devices.

  • The results of the determination of the reprocessing cycle and procedures and the actions to be undertaken in case one or more steps of the reprocessing cycle have not been performed.

  • The results of the assessment of the suitability of the single-use device for reprocessing and the data and information used for the assumption that the safety and performance of the reprocessed device will be equivalent to those of the original single-use device;

  • The results of the monitoring process

  • The description of the system for tracking the single-use device from the first use until

  • Its last reuse;

  • The description of the system for reporting serious incidents

  • The description of the system to identify and to dispose of the single-use device if it fails to meet any aspect of functionality, performance or safety, prior or during reuse.

Labeling Requirements for Reprocessed Single-Use Devices –


The label of Single-use devices that have undergone reprocessing must include below details -

  • The term 'reprocessed' prominently

  • Indicate either 'disinfected' or 'sterilized,' along with the specific method employed

  • The device's shelf life.

  • The name and address of the healthcare institution, and the external reprocessor

  • Maximum allowable number of reprocessing cycles

  • Actual number of reprocessing cycles the device has undergone

Incident Reporting for reprocessed Single-Use Devices –


Health institutions utilizing reprocessed single-use devices are required to report any serious incidents related to these devices to the appropriate Competent Authority. They must also send a copy of the report to the device manufacturer and, if applicable, the external reprocessor. The report should comply with the deadlines outlined in Article 87 of Regulation (EU) 2017/745 and include details such as confirmation that the device is reprocessed, the reprocessing entity's name, the number of reprocessing cycles performed, and the maximum allowed cycles.


Additionally, the report should describe the serious incident, including the failure mode, usage context, and patient outcomes. It should also provide an analysis of potential root causes related to device design, manufacturing, or reprocessing, along with proposed preventive and corrective measures and implementation timelines.


Reprocessed single-use devices involved in serious incidents should be segregated and preserved for five years, subject to the competent authority's instructions. If reprocessing is identified as a possible cause during an investigation, those devices should be disposed of. Health institutions should encourage staff and patients to report serious incidents related to reprocessed single-use devices. External reprocessors must promptly report any reprocessing failures that could jeopardize device safety, taking corrective actions as necessary and informing the competent authority. The health institution should maintain records of all incidents and perform an annual critical analysis. This analysis, including trends, should be shared with the manufacturer and, if relevant, the external reprocessor, and may be provided to the competent authority upon request. These findings are essential for enhancing the reprocessing cycle, revising technical documentation, or discontinuing certain single-use device reprocessing practices.


Tracing the Reprocessed Single-Use Devices –

Reprocessors must establish a tracking system that enables the continual identification of single-use devices from the initiation of the reprocessing cycle throughout their entire lifespan. This tracking system should maintain a record of the number of reprocessing cycles each single-use device has undergone and ensure that reprocessed devices can be accurately associated with the correct batch number, particularly for the purposes of field safety corrective actions.


Moreover, the tracking system should provide a mechanism for the healthcare institution to confirm that the single-use device reprocessed by the external reprocessor and subsequently returned to the healthcare institution is indeed the same device originally used within that healthcare facility and then sent to the external reprocessor for reprocessing.


The EU MDR regulations for reprocessed single-use devices (SUD) mark a significant step forward in ensuring the safety and quality of these devices in healthcare settings. With a focus on stringent reporting, tracking, and quality management measures, these regulations prioritize patient safety above all else. By adhering to the EU MDR regulations, health institutions and external reprocessors can play a pivotal role in enhancing the reprocessing cycle, reducing risks, and improving patient outcomes.


Are you involved in the reprocessing of single-use devices within the European Union? Stay informed and compliant with EU MDR regulations to ensure the safety of patients and the efficacy of reprocessing practices. Contact us to ensure that reprocessed single-use devices meet the highest standards of quality and safety. Your commitment can make a difference in the lives of countless patients across the EU. Get started today!


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