By Parminder Kalle, Senior Solutions Delivery Manager, Maetrics
Historically, postmarket surveillance is an area in which many medical device manufacturers have lacked focus, but regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for postmarket surveillance. In particular, regulatory bodies are establishing specific requirements for more proactive postmarket surveillance mechanisms, rather than relying simply on reactive systems, such as complaints monitoring. These requirements are expected to become even more stringent following publication of the new Medical Device Regulation (MDR) in Europe.
While the objective of this stricter regulation is to ensure that device safety issues are identified as early as possible, minimizing the possible impact on patient and user safety, its introduction will create some major challenges within the industry. For manufacturers wishing to introduce or maintain distribution of devices in markets that have new postmarket surveillance requirements — including markets across Europe and the U.S. — the importance of understanding and correctly implementing those requirements has never been more critical. Savvy manufacturers are thus rushing to review their postmarket surveillance systems, processes, and procedures to ensure that they are compliant with current requirements, that their staff is aware of forthcoming changes, and that there are no unpleasant surprises during their next regulatory body audit or review.
A 2002 report published by the Medical Devices Experts Group highlighted concerns related to conformity assessment and questioned the adequacy of device data provided by manufacturers as part of postmarket surveillance. Additionally, the report claimed, notified bodies did not sufficiently verify the adequacy of the clinical data that was provided. As a result, Europe’s National Competent Authorities (NCAs) have been working to ensure that the requirements for postmarket surveillance, as defined within the EU’s Medical Device Directives (MDD), are more clearly defined and specified moving forward.
Too Much Room For Interpretation
The MDD 93/42/EEC, Annex II tries to clarify the requirements for postmarket surveillance. It states that manufacturers should institute and maintain an up-to-date, systematic procedure to review any information gained from devices in the post-production phase. This clarification is intended as an addition to the Annex X provisions, which require manufacturers to implement effective means of both applying any necessary corrective actions and notifying the appropriate NCAs.
Additionally, the requirements of postmarket surveillance should be in direct proportion to the risk associated with each device, based on its intended use — for example, whether the product or technology is new to the manufacturer, the extent of available scientific knowledge on the technology, and the market experience of similar products and technology.
An incident report to the NCAs is mandatory when a “serious deterioration in health” is caused, in some way, by a medical device. Yet, determining what exactly constitutes a “serious deterioration in health” can be a serious headache.
The MEDDEV Vigilance Guidance Document provides some direction on this point, but again, different NCAs interpret the document in different ways. For example, the Medicines and Healthcare Products Regulatory Agency (MHRA) — the UK Competent Authority — considers a prolongation of surgery time requiring additional anaesthetic as a serious injury, with a benchmark of an additional 30 minutes being the trigger point. However, not all Competent Authorities are aligned on this point, and it can be argued, given that no two surgeries are the same, that a time difference of only 30 minutes cannot be considered significant.
In addition to establishing stricter procedures and reporting, MEDDEV 2.12-1, Vigilance Guidance Document, Revision 5, was updated in April 2007 with a requirement that manufacturers have in place suitable systems for proactive scrutiny of trends in complaints and incidents occurring with their devices. In fact, it states that manufacturers should submit trend reports to the appropriate NCAs when events or incidents that are usually excluded from individual reporting experience a significant increase, or a troubling trend develops.
Postmarket Clinical Follow-Up Studies
One of the aims of MEDDEV 2.12-2 is to provide guidance on when and how to conduct postmarket clinical follow-up (PMCF) studies. The document states that an appropriate postmarket surveillance plan is critical to identifying and investigating residual risks associated with the use of medical devices placed on the market, specifically, through systematic studies.
Factors influencing the need for PMCF include, but are not limited to:
- Innovation: novel technology or medical indications
- Significant changes to device or usage
- Risk factors
- Type of procedure: invasive or high-risk anatomical location
- Population: high-risk patients (e.g., elderly or pediatric)
- Safety: questions of long-term safety and performance
- Postmarket surveillance findings: adverse trends identified during postmarket surveillance, risks identified from literature or other data sources for similar marketed devices
- Emergence of new information on safety or performance
- CE marking, when based on equivalence
However, there are also situations where PMCF studies are not required — for example, when the medium/long-term safety and clinical performance of devices is already established. Even in these cases, though, manufacturers must provide a solid rationale to justify why a PMCF was not performed.
Risks And Benefits
The patient safety benefits of adopting more proactive postmarket surveillance methods are clear: safer devices and increased protection. But the benefits for the manufacturer are also huge, and include lower complaint handling costs due to fewer incidents, and greater customer loyalty and engagement. Establishing an on-going, rigorous postmarket surveillance investigation also allows organizations to rapidly identify product, design, and process improvements. As if these reasons are not motivation enough, organisations that fail to improve their postmarket surveillance procedures risk incurring a number of punitive measures, including hefty fines, jail terms for responsible executives, seizure of products, or the imposition of special compliance contracts.
Given that the requirements for postmarket surveillance are not identical in all geographies and are currently undergoing review or change in many countries, manufacturers should establish processes to ensure that they are compliant with the most up-to-date requirements for each market in which they distribute devices. Obviously, this requires time and expert resources, so manufacturers lacking such resources in-house should strongly consider bringing in external support.
Postmarket surveillance of medical devices is under intense scrutiny by many global regulatory bodies. It is increasingly considered a key activity in ensuring the early detection of device issues, and in protecting patient/user safety, so that only devices proven safe remain on the market. Keep in mind, though, that adhering to postmarket surveillance requirements also helps manufacturers identify design flaws earlier in development, leading to better products and improving reputation, customer engagement, and ultimately sales.
Compliance can be achieved in different countries through different ways, depending on factors like the number of countries to which a product is distributed, the cost of implementation, and the type of device. Some manufacturers will implement procedures that detail requirements for each country, while others adopt the highest standards across the board and apply them to all countries. Each approach has its merits and disadvantages, but what is certain is that manufacturers need to ensure they’ve identified and instituted proactive postmarket surveillance processes, and that they remain abreast of impending changes. Relying solely on the notifications of revision to applicable external documents leaves the manufacturer exposed to periods of non-compliance and forces the business to implement expensive, last-minute solutions to return to a state of compliance.
About The Author
Parminder Kalle is a senior manager at Maetrics Ltd. Having worked in the medical device industry for over 11 years, Parminder has in-depth experience and knowledge of quality systems and regulatory affairs spanning a range of business sizes and a variety of manufacturers. A lead auditor and an experienced manager, he has held operational and strategic positions, including sales and marketing. Parminder’s experience has given him insight into a range of medical device business and processes, including new product development, validation and marketing, in addition to his core quality and regulatory experience.
Having worked in both the U.K. and U.S.A, Parminder has extensive experience with both EU and US regulatory and quality requirements, including CE Marking, 510(k), QSIT, ISO 13485, 21 CFR 820 and own-brand labeling. He has also successfully gained product registrations in Asia Pacific, South America, the Middle East, and GCC Emerging Markets.