Post-Market Surveillance Under MDR

This piece is part of Lionbridge's series addressing language challenges under the new medical device regulation (MDR) in EU which applies from 26th May 2021. In this blog, we focus on the obligations of medical device manufacturers to carry out Post-Market Surveillance (PMS) and the reporting for medical devices made available on the European market under a CE mark. 

How Post-Market Surveillance Enables Risk Control Throughout the Device Life Cycle

One of the most commented-upon points of the MDR is the focus on the entire life cycle of medical devices including an increased emphasis on post-market surveillance and pharmacovigilance. Post-market activities are carried out because all medical devices carry residual risks on safety and performance throughout their life cycle. 

While these devices are of course designed and developed to ensure such risks remain at an acceptable level, manufacturers are obligated to perform post-production monitoring in the practical use of the product. This allows early detection of undesirable effects. It also reveals opportunities for product improvement or design modifications of the device. 

Manufacturer's Obligations Under MDR 

The key for a successful PMS is a systematic and controlled process of collecting, recording, analyzing and reporting data on the device. Both proactive surveillance and reactive vigilance reporting, e.g. incidents and field safety and corrective actions (FSCA), are necessary. 

Article 83 of the MDR defines PMS requirements as a system that the manufacturer "shall plan, establish, document, implement, maintain and update". It also states that this system must be an integral part of the manufacturer's quality management system. Furthermore, the PMS system must ensure a systematic collection, recording and analysis of data on the performance, safety and quality of a device which is proportionate to the risk class and type of device. 

For class I devices, a post-market surveillance report will be required (Article 85) and such report must include a summary of conclusions derived during analysis of post-market surveillance data as well as any actions taken for preventive or corrective purposes. For class II and III devices, a Periodic Safety Update Report (PSUR) is required under Article 86. 

Post-market clinical follow-up (PMCF) is another obligation under MDR. PMCF is a continuous process with the purpose of updating the clinical evaluation for devices throughout their lifetime. 

Content Boost and Interdependence

It is clear from the emphasis on PMS under the MDR that much more PMS activity and documentation will be necessary to keep devices on the EU market. PMS activities are required for each device; the burden of PMS is therefore dependent on the manufacturer's product portfolio. In principle, the richer the portfolio and the higher the risk profile of a manufacturer's products, the heavier the burden on internal resources to carry out and report PMS activities. In the end, PMS enhances patient safety and is an important measure to identify problems with design, manufacture or use of the device. 

There is a significant interdependence across the data and reporting managed during PMS. Technical changes to a product, data gathered under the vigilance system, post-market clinical follow-up, complaints, device failures or Adverse Events  (AE) can all drive updates across various reports that manufacturers must maintain during the lifetime of the product. 

Language Challenges and Control 

Besides the resources that manufacturers will need to invest in continuous post-market activities and reporting, the volume boost in PMS content under the MDR will also trigger more translations, updated translations and document control for local language content. Some content such as the Summary of Safety and Clinical Performance (SSCP) and Field Safety Notifications (FSN) will become publicly available on the EUDAMED database. It will therefore be important for manufacturers to not only ensure high quality translations in a language understandable to the public, but also to ensure these translations are controlled and updated throughout the device life cycle. 

Help for Post-Market Surveillance and Translations 

An excellent way to manage this challenge is to centralize translations with a Language Services Provider (LSP). Manufacturers can optimize their language and translation processes across content types as well as across their product portfolio and benefit from various automation tools during the translation and document management process. Certainly, the increased content and interdependence across PMS content calls for central management. 

Manufacturers would be wise to recruit outside help for these new regulations, which like so much of MDR, increase the burden on compliance teams. And at Lionbridge, we have the expertise to protect your teams from the extra workload. Get in touch today.