Planning is vital
Medical electrical equipment in Europe must comply with IEC 60601-1 in order to conform to the legal requirements of the Medical Device Directives. This applies to existing devices on the market and to new devices currently under development.
New design input requirements
- Manufacturers should specify the latest edition of 60601-1 as a new regulatory requirement within the Design Input Requirements.
- The manufacturer should also ensure that the design team are aware that the standard will have potential implications not just for the device design but may also trigger requirements for labeling, instructions for use (IFUs) and risk management plans.
Intended use and application
- Document the intended purpose of the device, together with any additional parts or accessories necessary to meet the intended use
- Communicate this data to all the design team members, including the appointed regulatory personnel on the team
- Plan this activity early in the design/development cycle, and it will enable a thorough review and correct application of the standard by the design team
- Ensure that the documentation thoroughly describes how the equipment or device is intended to be applied in practice and has specified the intended users and the application environment
- Include this documentation within the design history and risk management files
- Specify the evaluation of the relevant IEC as an early phase activity in the design plan
- Apart from product design implications, risk management records will need to demonstrate evidence of conformance to the requirements
- In addition, product labels may be impacted, and instructions for use may need to be changed as a consequence of the evaluation process
- The design plan should be kept up to date with new tasks and the required technical and regulatory resource requirements
General, particular and collateral standards
- Collateral standards complement 60601-1 and specify general requirements for safety applicable to a group of medical electrical equipment and or a specific characteristic of all medical electrical equipment, not fully addressed in the General Standard
- Particular standards may modify, replace or delete requirements contained in the General Standard or Collateral Standards
Design verification planning and reports
- Design verification evidence will be necessary to demonstrate conformance to requirements
- All of the planned design verification activities should be captured within documented and approved design verification protocols
- Corresponding design verification evidence may take the form of tests and documented evaluations
- Some may be focused solely on electrical, safety or mechanical requirements. Others may be in the form of documented inspection of risk management records and documented inspections of device labelling versus the requirements of the standards
Risk management file
- Create a risk management file in accordance with ISO14971
- The risk management plan should identify the review of the IEC 60601 series of standards as a risk management activity
- The risk analysis, risk evaluation and risk control phases should methodically address each applicable requirement
- The risk management report should confirm that all applicable requirements have in fact been addressed
Prepare with the end results in mind
These are some exemplary questions to consider as part of preparing for a successful outcome and to understand the scope of the task ahead:
- If a regulator samples clauses from applicable IEC 60601 standards what documented compliance evidence will exist within your Design History File records?
- If the device labeling and instructions for use are examined, how will they have adequately addressed all of the applicable requirements within the standards?
- What documented evidence will demonstrate that risk management records have met the requirements of ISO14971 and the 60601 series requirements?
The answers to the above will be derived by a methodical review of the requirements, discrete activity planning within the design control process and by appointing the experienced regulatory and design personnel necessary to complete the tasks.