Compliance for Supplying Paper and Electronic Instructions for Use of Medical Devices
Asha Meria J.
Medical Devices Regulatory Affairs Professional: RCC - MDR (RAPS) | Biomedical Engineer | MedTech Consultant - Striving to Improve the Lives of Patients and Healthcare Professionals 🙏
Are you a medical device manufacturer supplying both paper and electronic instructions for use (eIFUs) to the EU market under Regulation (EU) 2017/745?
If so, it is crucial to stay updated with the additional requirements outlined in Regulation (EU) 2021/2226.
Here are the key compliance requirements:
Consistency in Content
The content of the eIFU must be consistent with that of the paper format. This ensures that users have access to the same information, regardless of the medium they choose.
Secure website for eIFU access
The website hosting the eIFU must:
Protect against unauthorized access and tampering: Implement robust security measures to prevent data breaches and ensure the integrity of the eIFUs.
Comply with GDPR (Regulation (EU) 2016/679): Ensure that the website meets all data protection requirements, safeguarding personal data and user privacy.
Stability and Accessibility of the Internet Address
The internet address where the eIFU is accessible must be stable and directly accessible for the following durations:
For implantable devices and those devices without a defined expiry date: 15 years after the last device has been placed on the market.
For devices with a defined expiry date: 10 years after the last device has been placed on the market and at least 2 years after the end of the expiry date of the last produced device.
This address should be clearly displayed on the device label and/or paper IFU
Availability of Previous Versions
All previous versions of the eIFU must be displayed and made available, along with their dates of publication. This allows users and regulatory bodies to track changes and updates over time.
Conclusion
Non-compliance with these regulations can lead to significant consequences, including market access restrictions and legal liabilities. Therefore, it is essential to thoroughly review and update your technical documentation to meet these standards. Meeting these regulatory requirements not only ensures compliance but also enhances the reliability and trustworthiness of your medical devices. Stay proactive and diligent in maintaining the highest standards for both paper and electronic instructions for use.
For more information and assistance, feel free to reach out to aj@i3cglobal.com
#medicaldevices #eIFU #instructionsforuse #Regulation2021/2226