How senior management can support RA/QA staff meet new clinical data requirements under the European Medical Devices Regulation

Improvements to informed consent forms (ICF) recommended for US FDA Investigational Device Exemption (IDE) applications

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR requirements will increase the need for clinical studies; Proper investigator and investigation site selection is essential for successful studies; PMCF study sponsors and investigators should not underestimate requirements and obligations; In-person facility inspections and personnel interviews should be conducted to mitigate risks and determine proper clinical study support.

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR clinical data requirements may impact up-classified medical devices as well as recertification of some devices. Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020. Meeting the MDR’s PMCF requirements may impact some manufactures’ budgets in unforeseen ways.

EMERGO BY UL SUMMARY OF KEY POINTS: Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products. GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify. Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.

EMERGO BY UL SUMMARY OF KEY POINTS: The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements. Medical device companies’ PMCF studies will have to include specific components identified in the MDR. Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.

EMERGO BY UL SUMMARY OF KEY POINTS: Regulatory focus on medical device safety and risk management intensifying; Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster safety and risk management efforts; More robust safety and risk management processes to help medical device companies pivot faster when regulators change requirements.

EMERGO SUMMARY OF KEY POINTS: The anticipated update to ISO 14155 in 2019 includes stronger requirements for clinical risk management. The third edition of the ISO 14155 medical device clinical investigation standard will align more closely to ISO 14971 medical device risk management concepts. Quality management principles applied to clinical investigation audits are also introduced in ISO 14155’s latest edition.

EMERGO SUMMARY OF KEY POINTS: New US FDA guidance clarifies compliance requirements for clinical trial sponsors, investigators and IRBs whose studies fall under both agency and Department of Health and Human Services (HHS) requirements. The guidance focuses on differences in human subject protection requirements between HHS and FDA clinical investigation regulations. FDA is currently updating its clinical regulations to better align with HHS requirements regarding human subject safety and informed consent issues.

EMERGO by UL SUMMARY OF KEY POINTS: The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019. Broader risk management requirements are a key feature of the revised ISO 14155. Final publication of ISO 14155’s third edition will likely occur in mid-2019.

EMERGO SUMMARY OF KEY POINTS: US FDA has issued three new guidances focused on digital health technology regulations. The guidances stem from 21 st Century Cures Act requirements for timelier registration processes for digital medical technologies.