Key Sources For EU MDR Post-Market Surveillance
By Leeanne Baker, IMed Consultancy
There is a feeling within the industry that medical device manufacturers have let down their guard and are relaxing their efforts toward speedy EU MDR and IVDR compliance. This is a result of extensions for Medical Devices Regulation (EU) 2017/745 (MDR) to the end of 2027 for high-risk devices and to the end of 2028 for medium and certain lower risk devices, along with previous changes to In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation timelines.
Far too many device manufacturers are overlooking two important elements: first of all, the need to engage with Notified Bodies (NBs) early on to ensure they are not left without support as the deadline looms and NBs reach capacity; secondly, a number of new or enhanced requirements under MDR are actually already enforceable.
Specifically, post-market surveillance (PMS) requirements under the MDR have in fact been applicable since May 26, 2021, for all medical devices sold into the EU,1 regardless of a device’s MDR CE Marking status.
“’Post-market surveillance’ means 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.” — EU MDR Art.2 (60)
As a result, manufacturers must continue to gather clinical and safety-related data after completion of the CE certification process, approval, and market access. Best practice suggests that PMS should be undertaken cyclically every 12 months.
Sources For Post-market Surveillance
This non-negotiable task, however, places a significant onus on in-house teams, calling for specialist skills as well as numerous man-hours. To support businesses in assessing the efforts required to successfully set up and complete PMS, it can be useful to break activities into specific areas for attention, such as: published literature, feedback and social media monitoring, competitor device performance analysis, and risk assessments.
1. Published Literature
Regular and thorough analysis of key literature is, of course, the first port of call for manufacturers wanting to keep up with any relevant information that impacts the product’s use, performance, and safety. Trade publications that cover the market of application of the device as well as broader nursing, medical, or healthcare titles are also a good source of intelligence.
To make an accurate and relevant selection of the titles you should be following, it is critical to consider who your product users are, both from a clinical and patient perspective. For example, insulin pen producers would do well to read both patient publications and specialist diabetes nursing literature. An effective monitoring of these sources should take place cyclically, at least every 12 months, but many businesses may find it is easier to keep up to date with smaller morsels of information on a more frequent basis.
2. Feedback From Users And Patients, Including Posts On Social Media
Feedback from users of devices and their patients can be incredibly valuable in helping identify potential issues in a timely fashion. In addition to this, having a two-way communication channel with healthcare practitioners (HCPs) and patients helps detect potential off-label use. In fact, manufacturers are duty-bound to inform users if they discover off-label use of a device and take actions to inform users if they discover off-label use of a device, ensure they do not condone further similar use through any form of marketing, social media, or communications activity and prevent it as best possible.
Following relevant hashtags, key influencers, trade publications and patient groups on social media like Twitter or Facebook can offer significant insight.
Social media monitoring plays a key role in helping manufacturers connect with patients and users who tend to share their experiences more freely over their social media channels. They are also key to ensuring that marketing and communications departments are aligned with company compliance and messaging, such as not endorsing off-label use of devices.
Discovering off-label use need not be an only negative scenario. Social media chatter regarding an off-label use may drive your company to gather enough clinical, safety, and performance data to enable conformity assessment and approval to make new claims on your device, opening new market segments and new clinical applications.
3. Competitor Device Performance
Checking competitor performance by following their progress in the media and monitoring their appearance in industry journals, regulatory databases, and on other channels such as forums and social media is good commercial practice. It also supports the ongoing assessment of changes in the technological safety and performance profile of the device type, including changes in “clinical benefit” and “state of the art” (SOTA), both of which are important new elements of regulations.
From a patient safety perspective, complaints or potential issues concerning a device that is similar, or performing the same function, opens a window of opportunity to rectify any issue before it puts patients at risk.
4. Reviewing Risk Data
While risk management documents are typically prepared with great care for the initial regulatory approval of products, they are rarely updated with the same care after commercial launch. This activity, however, is one that should be carried out regularly to reflect new intelligence, statistics, and data that come to light from real-life use.
Time And Process: Assessing Resources
Finally, ensuring that you have allocated the right amount of effort and expertise to perform PMS is a critical step toward perfecting the process in good time for MDR deadlines. Manufacturers that maintain devices on the market under the transitional provisions are unable to make any significant changes in design or intended purpose of that device (MDR Article 120(3)), severely limiting their competitive advantage. The post-market surveillance requirements outlined here are conditional to maintaining the device on the market under those transitional provisions (MDR Article 120) and existing certificates may only remain valid provided that the required surveillance is also completed by the Notified Body that issued the certificate.
Acknowledging the key safety objectives that drive the regulation, setting out clear processes, and allotting resources to PMS are critical to ensuring this activity is carried out compliantly and effectively. Now is no time for medical device manufacturers to rest on their laurels; rather, it is an ideal moment to devote appropriate attention and thought to a key process with impact on both patient safety and business success.
Reference
- European Commission, Press Corner, Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation, https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_24 (last accessed 19.01.2022)
About The Author:
Leeanne Baker is the founder and Managing Director of IMed Consultancy. As a regulatory and quality professional and senior consultant, she guides the team with her experience in global medical device regulation and quality projects, supported by a solid grounding in industry. She advises clients on how to demonstrate devices maintain suitable safety and that business processes are appropriately controlled, with a solid appreciation of the commercial implications of regulatory decisions.