Safety Calls for Post-Market Surveillance in the EU MDR

Leeanne Baker
Managing director and senior QA/RA consultant
IMed Consultancy

Although deadlines for the Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) continue to be pushed back, it is critical that medical device manufacturers start to put newly required systems and measures into place and take a good hard look at the motivations driving the required changes. Specifically, the new MDR places greater emphasis on patient safety, resulting in new requirements for Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF), or the need for a Person Responsible for Regulatory Compliance (PRRC).

All these requirements have actually been applicable since May 26th, 2021, for all medical devices, and May 26th, 2022, for all IVDs sold into the EU, regardless of a device’s MDR CE Marking status, further highlighting the urgency with which PMS should be addressed by manufacturers with products in the EU. The objective of these measures is to ensure that products are constantly monitored for their safety and that any information regarding a potential threat to patients is rapidly collected, analysed, and addressed. It is no longer sufficient to only address issues following a complaint, but regular, careful evaluations regarding the device’s viability, performance, risks, and position in relation to the generally acknowledged state of the art (SOTA) in the field of medicine need to be made with a view to preventing damage early on.

PMS is a cyclical process that requires an ongoing effort on behalf of manufacturers as well as a solid plan and process to ensure activities are carried out effectively, thoroughly and in the most efficient and productive way possible. The considerable work onus required to maintain annual PMS includes monitoring channels and dedicating man-hours necessary to process information. It can therefore be useful to organise key activities into major areas such as the following five:

1. Analysis of published literature: It is critical to carry out regular reviews of published work and literature relating to the device’s market or to similar products. These reviews form the basis of information gathering and will yield data regarding the device’s use, performance, and safety as well as state of the art in the field of medicine.
2. Review risk data: Risk management documents are prepared at launch, but they also need to be updated regularly with new statistics and data emerging from actual use: as the product is used in the market, the more information about its performance is revealed.Best practice suggests that a risk review should be carried out at least once a year.
3. Social media chatter monitoring: Like consumers, patients and users will often reach to social media to share their thoughts, experiences, and opinions rather than engage with formal feedback processes. The information shared on social media is usually immediate and based on real-life scenarios making it incredibly valuable both for timely interventions and for understanding how the product is used in real life settings. Social media listening is also essential to ensure all device communication is aligned and that no off-label use is encouraged or tolerated.
4. Tracking competitor activity: Keeping track of industry literature and social media will also help to track competitor activity. The latter should be actively monitored as it provides fresh data for the ongoing evaluation of two new elements of the regulations: ‘clinical benefit’ and ‘state of the art’ (SOTA). Competitor device tracking helps identify any potential issues but also to ensure the business maintains a sufficient level of differentiation from competitor devices.
5. Connecting with users and patients: Unfortunately, issues with a product are most likely to be identified when it is in everyday use.Keeping in touch with patient groups and users of medical devices with feedback routes that are clear and easily accessible helps intercept side effects or discomfort that may emerge with use. In addition to this, keeping the conversation alive can help identify whether devices are being used off-label.

Building compliance towards the MDR and IVDR is crucial because manufacturers maintaining devices on the market under the transitional provisions are unable to make any significant changes in design or intended purpose of that device (MDR Art. 120(3), IVDR Art. 110(3)). Where the onus of PMS is too high for the existing team, enlisting the support of specialist consultants who are experts in satisfying post-market obligations, should provide ample reassurance that manufacturers are meeting their obligations and reaping the added benefits that post market surveillance can yield.