Quick Contact

MDR PRICING

Check our fee for various class

MDR Article 17 Overview

MDR Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) governs the reprocessing of single-use devices (SUDs) within the European Economic Area (EEA). Reprocessing is only permitted if allowed by national law and must comply with the provisions of this article.

Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer. For single-use devices reprocessed and used within a health institution, a new UDI is not required and Commission Implementing Regulation (EU) 2020/1207 applies, in combination with other possible requirements in national rules on reprocessing of single-use devices.

According to the Regulation (EU) 2020/1207 What is special with Re processing of single-use Devices

First preliminary assessment needs to be done to determine whether the single-use device is suitable for reprocessing
Determine a maximum number of reprocessing cycles which can be applied to the reprocessed single-use device while the performance and safety remain equivalent to the original single-use device.
The health institutions should have QMS and cover all parts and elements of the organisation regarding the reprocessing activities in accordance with regulations EU 2020/1207 and (EU) 2017/745.
General safety and performance requirements set out in Regulation (EU) 2017/745 apply to reprocessed single-use devices.
Health institutions should have a system in place to ensure traceability of the reprocessed single-use device, the reprocessing cycles conducted on a single-use device, and the final disposal of the reprocessed single-use device.
Also, it should have a system in place to collect information on serious incidents related to the devices and reporting to competent authorities
If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.
Reprocessors shall designate a Person responsible for reprocessing with sufficient expertise.
Justification should be provided that the reprocessor can conduct reprocessing for that particular device and make publicly available the list of devices that it can reprocess

List of EU Countries Permit the Reprocessing of Single Use Device

With the new MDR 2017/745, Article 17 has brought a significant impact. Any parties including hospitals interested in the certification, pls contact us for complete service

REQUEST QUOTE

Preliminary Assessment

Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2021 by Directive 93/42/EEC, may be reprocessed.
The latest scientific evidence should be there that the reprocessing of this device is considered safe
Conduct an analysis of the properties of the single-use device, taking into account all available documentation and information on the single-use device to ensure sufficient understanding and know-how on design, constructional properties, material characteristics, functional properties, and other risk factors related to the reprocessing of the single-use device, including its previous use.
A written positive opinion needs to be provided by the person responsible for reprocessing based on the decision of the health institution concerning the suitability of a single-use device for reprocessing.
Reprocessors shall establish a monitoring process to verify that the single-use device is not withdrawn from the market and the certificate of conformity of the single-use device has not been suspended.
Include the procedure by which the reprocessing cycle is established The reprocessing cycle shall be determined based on the documentation and the results of a technical assessment including, when appropriate, physical, electrical, chemical, biological and microbiological tests, and reverse engineering.
The reprocessing cycle shall be established in writing and shall be validated by the health institution. The reprocessing cycle shall describe each step of the reprocessing. For each step, the relevant procedure shall be established, and each step shall be validated. up to the maximum allowed number of reprocessing cycles.
A tracking system should be in place allowing the identification of the single-use device throughout the reprocessing cycle and the lifetime of the reprocessed single-use device.
The reprocessing cycle shall be monitored through periodic routine tests and contamination controls, physical, electrical, chemical and biological monitoring and testing of process parameters and calibration.
The reprocessed single-use device shall be released after it is confirmed that cleaning, disinfection and sterilization steps and any testing, as appropriate, assure that the reprocessing cycle has been completed in compliance with the requirements applicable to such cycle.
Determine the maximum number of reprocessing cycles which can be applied to the reprocessed single-use device, during which the performance and safety of that single-use device remain equivalent to the original single-use device.

Technical Documentation requirements for Single Use Devices as per MDR

Technical documentation on reprocessing activities should include, the procedures for controlling and periodically monitoring premises and equipment and also any decision related to reprocessing a type of single-use devices. The technical documentation specific to each model of single-use device which should include

The results of the determination of the reprocessing cycle and procedures and steps of reprocessing
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 its first use until its last reuse;
The description of the system for reporting serious incidents
The description of the system to identify and dispose of the single-use device if it fails to meet any aspect of functionality, performance or safety, prior to or during reuse.

Specific Set of Procedures the reprocessing Establishments to Maintain

A validated decontamination procedure adapted to the properties and characteristics of the single-use device and the risks linked with its use.
Procedure specifying the conditions under which the single-use devices shall be transported to the reprocessing premises in closed identified and dedicated containers
The necessary requirements in terms of microbiological and chemical properties of water, chemicals, and other products used in the reprocessing shall be set out in the procedures for each specific cycle.
Validated automated procedures for cleaning, disinfection and sterilization
A validated method to remove Cleaning and disinfectant solutions and the sterilizing agent should be described in the procedure
Procedure for Monitoring of sterilization cycles and release of sterilized single-use devices

MDR Article 17 Requirements for Healthcare Institutions

Assessment of Feasibility:

Assess whether reprocessing is appropriate for specific SUDs.
Only devices that meet safety and validation criteria can be reprocessed.

Partnerships with Approved Reprocessors:

Engage only with reprocessors certified under MDR.
Ensure reprocessors provide evidence of compliance and process validation.

Documentation and Reporting:

Maintain records of reprocessed devices, including their reprocessing history and validation data.
Report any adverse events associated with reprocessed devices.

Internal Reprocessing Facilities:

Healthcare institutions with in-house reprocessing must meet the same regulatory standards as external reprocessors.

What is the requirement of the reprocessor?

Quality Management System (QMS):

Implement a robust QMS aligned with MDR requirements.
Document all processes, from initial cleaning to packaging and sterilization.

Risk Management:

Conduct a comprehensive risk assessment for each reprocessed device.
Ensure the device’s integrity, performance, and sterility are maintained after reprocessing.

Validation of Processes:

Validate cleaning, disinfection, and sterilization processes.
Provide evidence that the reprocessing does not compromise the device’s functionality or safety.

Traceability:

Ensure full traceability of reprocessed devices, including unique device identifiers (UDIs).
Labelling and Instructions for Use (IFU):
Clearly label reprocessed devices and provide revised IFUs.
State the maximum number of reprocessing cycles validated for the device.

I3CGLOBAL provides a team of MDR experts who offer complete guidance and documentation support for MDR Article 17 compliance by preparing technical documentation and interacting with Notified Bodies, ensuring proper implementation of requirements for compliance.

Frequently Asked Questions

What are reprocessed SUD’s?

A reprocessed Single-Use Device (SUD) refers to a medical device that is originally labelled and intended by the manufacturer to be used only once but has undergone a validated process of cleaning, disinfection, or sterilization so it can be safely reused on patients.

What Is Reprocessing?

Reprocessing involves cleaning, disinfecting, testing, and repackaging a single-use medical device to make it suitable for reuse. While originally intended for single use, advancements in technology and validation have enabled safe reprocessing of certain devices, provided strict requirements are met.

What is re-processor and Who can be re-processors?

‘reprocessor’ means the health institution and the external reprocessor reprocessing single-use devices; Reprocessors fall into two categories under this regulation:

External Reprocessors: Specialized third-party companies.

In-house Reprocessors: Healthcare institutions performing reprocessing within their facilities.

Regardless of classification, the reprocessor is considered the manufacturer of the reprocessed device under MDR and must fulfill all manufacturer obligations.

Which devices qualify for reprocessing as per MDR Article 17?

Not all SUDs are suitable for reprocessing. Factors such as material properties, intended use, and design complexity influence feasibility. High-risk devices (e.g., invasive or implantable devices) are subject to stricter scrutiny.
Exemptions may apply if:
The device cannot be safely reprocessed.
There is no validated reprocessing procedure available

Which Medical devices are inappropriate for Reprocessing as per MDR Article 17?

Medical Devices emitting radiation
Medical Devices utilized for administering cytostatic or radio-pharmaceutical medicines
Medical Devices having medicinal substances
Medical Devices for application in invasive procedures on the central nervous system
Medical Devices that carry a risk of transmission of spongiform encephalopathies
Implantable medical devices
Medical Devices for which serious incidents have occurred after reprocessing (the cause of the incident is related to the reprocessing, or is relevant to it in any way)
Medical devices with batteries that cannot be altered or have a risk of malfunctioning after reprocessing
Medical devices with internal data storage important for the use of the device and which cannot be modified or offers a risk of malfunctioning after reprocessing
Medical devices with cutting or scraping blades
Device drills or components wearing off that are no longer appropriate after the first usage and cannot be modified or sharpened before the subsequent medical procedure