Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes.
By: Peter Bowness
Director, International Regulatory Affairs
· All medical devices introduce risk to the patient and to a lesser extent, the user. Managing this risk is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes.
Recently I took my 8-year-old to the National Coal Mining Museum for England (well worth a visit), including a tour underground of the actual mine, 140m down. The guide, himself a former miner and highly knowledgeable, spoke of interface friction in coal seams and the violent collapse that this may cause, potentially resulting in harm to miners. Coal mining is certainly a risky business - which set me thinking about risk in my line of business, i.e., medical devices.
'System' 'aligned' 'reflected' 'inter-dependent' are key terms that appear in the EU regulations for medical devices and in vitro diagnostics.
Risk management requirements in the EU regulations substantially upgrade expectations on risk management and how risk is aligned with, reflected in and inter-dependent on clinical evaluation (including SSCP), post market surveillance (including PSUR), labelling and information provided to users.
The risk management system required by the regulations encompasses the risk management process defined in EN ISO 14971:2019, and is a continuous, living system that must be established, documented, implemented and maintained for the entire life cycle of the device, including continuous reassessment of benefit:risk and the risk management system.
EN ISO 14971:2019 clause 10 provides information on the post market system for information collection, review and, importantly, actions to be taken to assess the impact of post market data on both the device itself and the risk management process. Clause 10 does not explicitly require this assessment to be applied to the wider risk management system; manufacturers therefore need to consider the wider impact and integration of this critical process step into their risk management system.
Notified Bodies are required to address this interface between a manufacturer's risk management process and its appraisal and analysis of the pre-clinical and clinical evaluations and ensure that the clinical evaluation adequately addresses the relevant GSPRs in Annex I and that it is appropriately aligned with the risk management requirements.
If your risk management system does not conform to these key terms and requirements, the conformity assessment process under the EU regulations will prove challenging, potentially impacting your ability to access the EU market. Market availability of essential medical products is vital in maintaining patient access to safe and effective healthcare.
Friction at the interface of market access, device design, clinical data, risk control and information given to users is a complex challenge requiring thought and diligence. The failure of this interface places many patients in harms way, avoidance of which should be a key priority of any medical device manufacturer.
MCRA has a team of industry leading specialists focused on the full scope of European and international regulatory needs include risk management expertise. Our focus is driving rapid market access while maintaining the highest standards of patient safety. Navigating complexity is what we do.
Dr. Peter Bowness has over 16 years of international regulatory and clinical compliance experience in the medical device sector. He is recognized as a thought leader in regulatory and conformity activities for devices utilizing materials of human, animal and biologic origin, guided tissue regeneration, soft tissue implants and organ preservation. Dr. Bowness is specialized in medical and biologics technologies with over 9 years at the British Standard Institution (BSI). Within BSI, Dr. Bowness was the subject matter expert on risk management for medical devices under ISO 14971, information to be provided to users under ISO 20417 (replacing EN 1041), graphical symbols for medical devices under ISO 15223 and procedure packs under Directive Article 12 and Regulation Article 22 and wrote procedures and guidance on the interface between risk management, clinical evidence, PMS/PMCF and information provided to users.
Visit www.mcra.com to see how we can help with risk management for your medical devices.