✕
☰

Mastering EU MDR compliance: patient safety and Post-Market Surveillance

Timothy Bubb, technical director, iMed Consultancy, discusses leveraging deferred MDR implementation to focus on patient safety and competitivity.

rarrarorro Shutterstock

Target dates for the implementation of the EU Medical Devices Regulation 2017/745 (MDR) have been rescheduled, but it is important to be aware that a number of new or enhanced requirements under MDR are already enforceable. In fact, requirements such as  

have been applicable since 26th May 2021 for all medical devices sold into the EU, regardless of a device’s MDR CE marking status.  

However, efforts to comply with the MDR can also prove useful for export strategies outside the European market. So, not only is preparedness key to ensure international competitiveness, but effective PMS is also a requirement for continuing market access in other international markets. 

Proactive PMS can lead to safer medical devices 

The MDR gives particular importance to patient safety through the gathering of clinical and safety-related data after the conclusion of the CE certification process. Indeed, it is no longer enough to manage issues in the light of a complaint. Manufacturers are required to gather regular, careful assessments relating to a device’s performance and safety profile.  

This makes sense, as the objective is to prevent problems related to patient safety through the systematic use of proactive Post Market Surveillance, rather than address issues once they have spiralled into a more significant issue. 

PMS data collection: what needs to be done 

Post Market Surveillance requirements include the necessity to create a detailed PMS plan, including consideration for appropriate Post Market Clinical Follow Up planning.   

For Class IIA devices, PSUR reports must be completed and updated at least every 2 years. This update frequency increases to at least annually for Class IIB and Class III devices. Additionally, cyclical PMS reports are required for Class I devices. 

In a nutshell, PMS requires regular data collection from the following five main sources to identify any potential problems related to patient safety and device performance before they become a more pressing issue: 

Risk management data - Best practice suggests that reassessing the risk data for a device should be a cyclical process carried out at least once a year, or as new information materialises. It is important that manufacturers not only prepare risk management documentation for the launch of their products but also ensure documents are adequately updated with new statistics and ongoing data.  

Competitor data - Monitoring competitor device performance is both good commercial practice, and also demonstrates compliance with important new elements of the regulations such as the ongoing assessment of ‘clinical benefit’ and ‘state of the art’ (SOTA). Tracking the performance of competitor and similar-functioning devices also gives manufacturers time to assess any issues relating to competitor products and rectify on their own device before a similar patient safety issue occurs. 

Literature review data - Published literature, related specialised magazines and general healthcare periodicals involving the manufacturer’s device and market environment, are vital clinical evidence sources that can highlight risks or provide stronger proof of a product’s clinical benefit. Publications are also an excellent source for covering issues relating to off-label use or common interactions with other devices or drugs. 

Social Media data – Both patients and users share experiences over social media making this an ideal source for opinions, concerns, and insights about the device and how it is being used.   

Patient and end user data – Building on the social media, listening is engaging in a two-way conversation with patients and users. This can give important information to manufacturers helping them to identify any potential issues with their product such as discomfort or side-effects in specific groups of patients.  

Ideally this constant, systematic data sourcing should be carried out by specialist teams with suitable skills who can dedicate the necessary time. Enlisting the support of specialist consultants who are experts in this field, should provide reassurance that manufacturers are meeting their obligations, and at the same time, ease the considerable pressures on busy teams. 

Back to topbutton