Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA
Designing the organization and process for the future
Post-market surveillance in Medical Devices & IVDs (MedTech) has traditionally been reactive. It has focused on investigation and reporting adverse events, device malfunctions, or patient injuries in order to trigger product returns, modifications, exchanges, and recalls as necessary. However, as medical device complexity increases, Post-market surveillance will need to be more rigorous, leading to earlier detection of potential product failures in the field.
Regulatory authorities are starting to emphasize the importance of Post-market surveillance plans that are based on proactive data gathering and analysis, rather than relying on reactive data gathering once a post-market event has been reported. To meet these needs, manufacturers should take a risk-based approach when considering clinical and post-market planning.
Although regulatory authorities are requiring a more proactive Post-market surveillance approach, there is still a lack of prescriptive advice on how to do this, and it is being left to the manufacturers to decide the best way to design their systems. The approach does not need to be complex, but the manner in which MedTech approaches the task and manages the data mining and analysis needs to be modified.
The developed MedTech markets (USA, Canada, EU, Japan, Australia) have mature systems for Post-market surveillance which have been in place for many years. Post-market surveillance systems are also being required in emerging markets (Asia Pacific, Middle East, Africa, Latin America) following IMDRF guidelines with some cross- regional harmonization for MedTech.
Current global regulations and guidelines for Post-market surveillance are generally limited to complaint management, vigilance reporting, and recall management. However, this need is changing. The new EU Medical Device Regulation (EU MDR) and the EU In-Vitro Medical Device Regulation (EU IVDR) are good examples of the new requirements, requiring improved Post-market surveillance actions including Periodic Safety Update Reporting (PSUR).
Current practices are fractured and lack active surveillance methods
Typical departments managing product safety and patient vigilance data, including Quality Assurance or Regulatory Affairs, are siloed. These departments will often “meet the regulations” for post-market safety compliance. However, some departments sit outside of the manufacturer’s QA/RA Management Systems, therefore, all market feedback is not captured in the systems.
For instance, important information from user meetings, brand surveys, and social media is not adequately captured and trended.
External channels, including distributors/agents/partners (OEM) often represent a significant percentage of a device company’s sales, however, they generally have poor processes to collect and communicate data that may impact safety and have poor traceability of product.
A lack of safety data exchange agreements with distributors, particularly in partially regulated countries, limits safety data collection. Additionally, some device companies have immature systems for device complaint handling, and the majority are off-the-shelf systems that may be customized for their specific use. Tracking and trending needs are poorly defined as well. Post-market surveillance must be designed to generate useful information on the device based on real-life usage data, enabling expeditious design and usage changes. Current standards and guidance information on Post-market surveillance reflect this reality.
The concept of proactive post-market surveillance – standards/guidance are in place
Post-market surveillance has been a requirement for many years in supporting CE marking of medical devices. Risk management is key to the process, including clinical evaluations and Post-Market Clinical Follow-up studies:
- ISO 14971:2007+ Medical Devices – Application of Risk Management to Medical Devices, is a global standard that includes process requirements for all stages of the product lifecycle including Post Market
- MEDDEV. 2.7.1 Rev.4, June 2016. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. Guidelines for Manufacturers and Notified Bodies in how to carry out Clinical Evaluation
- MEDDEV. 2.1.2 Rev.2, January 2012. Post Market Clinical Follow-up Studies: A Guide for Manufacturers and Notified Bodies. Guidelines for Manufacturers and Notified Bodies on how to carry out PMCF studies in order to fulfill Post-market surveillance obligations of the MDD/AIMDD
+ The ISO/DIS 14971:2018(E) version is now out for industry comments/voting. This version expands the need for enhanced Post-market surveillance by increasing the needs under Section 10: Production and Post-production Activities. It provides for more proactive Post-market surveillance data gathering in the post-market phase. As this standard is still under development, references here pertain to the current standard, ISO14971:2007 (EN ISO 14971:2012).
ISO14971:2007 Annex F – Risk Management Plan
Annex F, Clause 7 – Method or methods of obtaining relevant post-production information. The method or methods of obtaining post-production information can be part of established quality management system procedures (see for example ISO 13485:2016 , 8.2). Manufacturers should establish generic procedures to collect information from various sources such as users, service personnel, training personnel, incident reports, and customer feedback.
The risk management plan should include documentation of decisions based on a risk analysis. Documentation also should indicate what Post-market surveillance is appropriate for the device, such as whether reactive surveillance is adequate or whether proactive studies are needed. Details of clinical studies envisaged should be specified.
The future MedTech safety landscape
The significant “surveillance” gaps within MedTech companies are not just due to the lack of IT systems for improved collection and data analytics. The solution rests more in process transformation and organizational alignment to ensure that the relevant product data collected across all functional departments is captured adequately. All the stakeholders involved in identifying and collecting Post-market surveillance data have to be included in the process:
Effective post-market surveillance through engagement
A centralized group for Safety Surveillance and Medical Affairs ensures proactive management of safety data. This group provides medical services to all functional departments and provides medical input into QMS elements including Risk Management, Post-market surveillance, CAPA, MDR and Field Actions.
Applying this model across the organization will increase the opportunities for the collection of Post-market surveillance data.
Then, utilizing technology solutions, adopt the similar signal detection systems employed in the Pharma industry to analyze the data and to identify potential safety issues before they cause harm or serious injury to patients and/or users of the device.
Seek support to stay ahead and gain a competitive edge
Many medical device manufacturers struggle with the concept of a centralized safety function and a proactive or predictive post-market surveillance system. IQVIA has the experience, vision, and systems to support manufacturers in identifying the needs and finding the most relevant solutions for their organization.
MedTech companies can satisfy the regulatory needs and achieve a competitive edge by early implementation of proactive post-market surveillance programs that will reduce the tangible costs of down-stream field corrective actions.
Planning for the New European Regulatory Environment
This brochure from IQVIA outlines the key elements to both the Medial Device and IVD Regulations, and more.