Distinguishing Between Medical Device Servicing and Remanufacturing Activities
This guidance aims to clarify the distinction between servicing and remanufacturing activities performed on medical devices that are intended to be reused and maintained. It provides recommendations to help determine whether activities performed on devices are likely remanufacturing and outlines regulatory requirements applicable to remanufacturers.
Recommended Actions
- Implement process to evaluate whether activities constitute remanufacturing using provided flowchart and criteria
- Document rationale for determinations regarding remanufacturing activities
- Establish quality system compliant with regulatory requirements if performing remanufacturing
- Register establishment and list devices if performing remanufacturing
- Implement Medical Device Reporting procedures
- Validate and update labeling as needed for remanufactured devices
- Conduct risk assessments for changes to device specifications
- Maintain records of all evaluations and decisions regarding remanufacturing
- Obtain necessary marketing authorizations before conducting remanufacturing
- Implement process for evaluating cumulative effects of multiple changes
Key Considerations
Non-clinical testing
- Verification and validation testing may be necessary to evaluate changes to device specifications
- Testing should be performed to verify device remains within original performance and safety specifications
- Testing should evaluate cumulative effects of multiple changes
Software
- Software changes require special consideration due to their impact on product architecture and specifications
- Many software changes are likely remanufacturing except for specific activities like:
- OEM authorized updates/upgrades
- Running diagnostics
- Cybersecurity updates authorized by OEM
- Data backup/recovery
- User account management
Cybersecurity
- Installation of cybersecurity updates must be authorized by OEM
- Assessment of viruses, malware and other cybersecurity issues is permitted
- Turning on/off connectivity features must be consistent with OEM intended use
Labeling
- Remanufacturers must modify and validate labeling changes associated with remanufacturing activities
- Must include remanufacturer identifying information
- Must obtain new UDI
- Must modify directions for use, specifications, and warnings as needed
- OEMs should provide adequate servicing instructions for routine maintenance and repair
Biocompatibility
- Changes affecting biocompatibility require assessment
- Changes to materials contacting body tissue must be evaluated
- Impact on reprocessing instructions must be assessed
Safety
- Safety specifications established by OEM must be maintained
- Changes to safety features like alarms, sensors, interlocks likely constitute remanufacturing
- Risk assessment required for changes affecting safety specifications
Other considerations
- Quality System requirements apply to remanufacturers
- Registration and listing requirements apply
- Medical Device Reporting requirements apply
- Documentation of decision-making process required
- Risk-based approach recommended for assessing changes
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Unique Device Identifier (UDI) Form and Content Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ISO 14971: Medical devices – Application of risk management to medical devices
- ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
Original guidance
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