For decades the use of clinical justifications based on device equivalence (predicate device) has been the standard for the MedTech industry. Amongst medical device manufacturers, it was common practice to treat risk management and clinical evaluations as separate, stand-alone processes. Today however, the Medical Device Regulations (MDR) regard risk management and clinical evaluation as interdependent processes, calling for careful alignment of the risk management system with the clinical evaluation. The European regulatory authorities expect clinical risks being addressed in clinical investigations, clinical evaluations and post-market clinical follow-up.
This blog post introduces a series of articles around clinical trials in medical devices. Stay tuned if you are in the MedTech business…
HEADS-UP: It is anticipated that the EU MDR will come into effect by mid-2020. The new regulations will replace the Medical Device Directive (MDD Council Directive 93/42/EEC) and the Active Implantable Medical Device Directive (MDD Council Directive 90/385/EEC). Even though the MDR’s date of application isn’t until 2020, medical device manufacturers should be focusing on their transition plans to the new regulations now.
Clinical Use and Production are Both in Focus
In context of the implementation of Risk-based Monitoring (RBM) services the first thing that might come to your mind is the new, stringent requirement for clinical evidence for Class III and implantable devices. The MDR however, also puts more emphasis on any risks related to the production of a device. Critical suppliers for example, should be integrated into the manufacturer’s quality system to subsequently address all relevant, critical risks upfront and be ready for any unannounced audits.
Risk management is emphasized in the regulation as an iterative process throughout the entire life cycle of a device, requiring the following activities to be conducted:
- a risk management plan for each device
- identification and analysis of possible hazards associated with each device
- estimation of risk associated with the intended use and misuse of the device
- risk mitigation (reduction or elimination of risk)
- assessment of production and post-market information on the documented risk assessment
- changes to control measures (e.g. safety by design, alarms, safety information) when required based on the assessment of production and post-market information
Another risk concerns the OBL (Own-Brand Labeling) of medical devices. Every manufacturer must have access to full technical documentation according to the new MDR. This would require that OBL manufacturers hand over those files whenever requested by auditors, which may present an obstacle if the OEM (Original Equipment Manufacturer) data sources are incomplete or lacking.
Like pharma companies, medical device manufacturers are now similarly challenged to transform their traditional risk management strategies into a holistic, prospective concept.
Post Market Clinical Follow-up
Clinical evidence is not a new requirement. Under the old MDD, lower risk devices were required to have Clinical Evaluation Reports (CERs) and higher risk devices needed clinical data. CERs are still required, however the new MDR goes further. Clinical evaluation is a permanent process that must be covered by risk management plans and reports. The Post Market Clinical Follow-up (PMCF) summary of safety and clinical performance must be based on real-life data and updated “at least” annually which means a more frequent assessment could be expected.
A Risk-based Approach for the Complete Product Life-Cycle
Class III and implantable devices are expected to have clinical data derived from clinical investigations that were conducted under the supervision of a sponsor. Those clinical studies need to follow Good Clinical Practices (GCPs) such as those outlined in ISO 14155:2011.
The EU MDR is setting the stage for busy times ahead in which clinical evidence plays a big role. In addition, the increasing complexity of new medical devices, as well as the size and global nature of the medical device trials, introduce a greater potential for error. Similar to clinical trials in pharma, intelligent Risk-based Quality Management (RBQM) could very well serve as the key driver of quality in medical device trials, i.e. protecting human subjects, ensuring regulatory compliance and ensuring data integrity. As a matter of fact, when applied as a holistic concept, a risk-based approach could cover the entire pre- and post-market MDR footprint, enabling medical device manufacturers and innovators to better understand, manage and mitigate the growing uncertainties.
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EU Medical Device Regulations
Council Directive 93/42/EEC
Council Directive 90/385/EEC
FDA – Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions