No Leaning back for MDD Medical Devices

Post-market surveillance (hereinafter: “PMS”) is defined as all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.  

Every manufacturer of medical devices should have a PMS system available to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of the medical device throughout the entire lifetime. The data gathered shall be used to: 

1. Determine corrective and preventive actions,
2. Update the benefit-risk determination and to improve risk management,
3. Update the design and manufacturing information, instructions for use and labelling,
4. Update clinical evaluations,
5. Update the summary of safety and clinical performance,
6. Identify needs for preventive, corrective or field safety corrective action,
7. Identify options to improve the usability, performance and safety of the device,
8. When relevant, contribute to the PMS of other devices, and 
9. Detect and report trends.  

The PMS activities should be based on a PMS plan, part of the technical documentation of the medical device.  

For class I medical devices, the results and conclusions following from the PMS data gathered shall be reported in a PMS report. For class IIa and higher classified medical devices this information needs to be summarized in a periodic safety update report (“PSUR”). 

Vigilance concerns the reporting of incidents to the relevant competent authorities. For manufacturers of medical devices, there are certain situations that must be reported to the authorities. Specifically, the following must be reported for all medical devices placed on the European market: 

1. Any serious incident with devices on the European market, except for side-effects which were yet expected, clearly documented in the product information, quantified in the technical documentation, and are subject to trend reporting.  
2. Any field safety corrective action in respect of devices on the European market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the European market, if the reason for the field safety corrective action is not limited to the device made available in the third country. 

Market Surveillance refers to the checks performed by competent authorities on the conformity characteristics and performance of devices. This may include the review of documentation and physical or laboratory checks on the basis of adequate samples.  

All manufacturers of medical devices are subject to the annual surveillance activity plans of competent authorities. What may they check? Specific attention has been communicated on activities related to risk assessment and risk management, vigilance data and complaints. Competent authorities may ask to make documentation and information available and/or perform unannounced inspections of the premises. 

The European Commission has made available certain modules of the European database on Medical Devices; Eudamed. The final version of Eudamed shall include the following electronic systems: 

• Devices, 
• UDI(s), 
• Economic operators, 
• Notified bodies and certificates, 
• Clinical investigations, 
• Vigilance and post-market surveillance, and 
• Market surveillance. 

This system requires manufacturers to, amongst other things, register themselves and their medical device(s). At the moment the following Eudamed modules are available: 

• Economic operators 
• Devices 
• Certificates

This means that all manufacturers of medical devices must submit the required information in the Eudamed database.