How to comply CE with RPM software

Obtaining a CE Mark for RPM software, especially if it is classified as a medical device, involves a detailed and regulated process. Here’s an overview of how to obtain a CE Mark and whether your company can do it by itself:

Steps to Obtain a CE Mark

1. Determine Classification: Classify your device according to the EU Medical Device Regulation (MDR) 2017/745. The classification will depend on the risk associated with the device, ranging from Class I (low risk) to Class III (high risk).
2. Conformity Assessment Procedure: Choose the appropriate conformity assessment route based on the classification of your device. For Class I devices, manufacturers can self-certify. For higher-risk devices (Class IIa, IIb, and III), involvement of a Notified Body is mandatory.
3. Implement a Quality Management System (QMS): Implement a QMS according to ISO 13485. This system helps ensure that your product consistently meets customer and regulatory requirements.
4. Technical Documentation of RPM software: Prepare comprehensive technical documentation as required by the MDR. This includes:
   • Device description and specifications
   • Design and manufacturing information
   • Risk management and clinical evaluation reports
   • Instructions for use and labeling
   • Post-market surveillance plan
5. Clinical Evaluation: Conduct a clinical evaluation to demonstrate the safety and performance of the device. This includes a review of clinical data, literature, and studies.
6. Appoint a Person Responsible for Regulatory Compliance (PRRC): As per the MDR, appoint a PRRC who ensures compliance with the regulation.
7. Conformity Assessment:
   • Self-Certification: If your device is Class I and does not require sterilization or have a measuring function, you can self-certify.
   • Notified Body Involvement: For Class IIa, IIb, and III devices, submit your technical documentation and QMS to a Notified Body for review and certification.
8. Declaration of Conformity (DoC): Draft and sign a DoC, which states that your device complies with the applicable requirements of the MDR.
9. CE Marking: Once the Notified Body approves (if applicable), affix the CE Mark to your device. This indicates compliance with EU regulations.
10. Register the Device: Register the device with the EUDAMED (European Database on Medical Devices).

Can a Company Do It by Itself?

• Self-Certification: For Class I devices that do not require sterilization or have a measuring function, companies can self-certify. This means they can carry out the conformity assessment procedure themselves, prepare the DoC, and affix the CE Mark without the involvement of a Notified Body.
• Notified Body Involvement: For Class IIa, IIb, and III devices, or Class I devices with measuring functions or that are sterile, you must involve a Notified Body. These independent organizations are designated by the EU to assess the conformity of certain products before they are placed on the market.

Practical Considerations

• Expertise: Ensure your team has expertise in regulatory requirements and quality management systems. Consulting with regulatory experts or hiring a regulatory affairs specialist can be beneficial.
• Documentation and Testing: Thoroughly document all aspects of your device’s design, manufacturing, risk management, and clinical evaluation. Ensure that your testing procedures are rigorous and meet the required standards.
• Continuous Compliance: Stay updated on regulatory changes and ensure continuous compliance, including post-market surveillance and reporting.

By following these steps and ensuring adherence to all regulatory requirements, your company can successfully obtain a CE Mark for your RPM software.