Angela Brown, B.S.
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
It started with the transition to the new European Union Medical Device Regulation (EU MDR) which incorporated more scrutiny on clinical evidence. And, more recently, it expanded to include the updated ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good Clinical Practice (GCP).
The third edition of the ISO 14155 guidance outlines standards for the design, conduct, recording and reporting of medical device clinical studies, providing manufacturers with information on how to implement GCP for pre- and post-market clinical investigations to determine safety and performance of a medical device. This standard is valid from July 2020 with no official transition time, and, specifically, outlines requirements intended to:
- Protect the rights, safety and well-being of human subjects
- Ensure the scientific conduct of the clinical investigation and the credibility of results
- Define the responsibilities of the sponsor and principal investigator
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices
New changes to the 2020 revision of ISO 14155
Widely used across the world by manufacturers and regulatory authorities, the updated edition introduces clarifications to facilitate compliance to other international standards. For example, the U.S. Food and Drug Administration (FDA) recognises the ISO 14155 standard for medical device trials and accepts clinical data collected outside the U.S.
To align with recent regulatory changes, updates include (1) a stronger emphasis on the role of clinical evidence, as presented in the EU MDR; (2) the addition of clinical risk management to the manufacturer’s responsibility; and (3) improved guidance on clinical study design. Also, the document provides more information on conducting safer medical device clinical trials with better evidence, detailing informed consent, vulnerable populations, data protection and statistical considerations.
Plan and execute an ISO 14155- and EU MDR-compliant clinical trial
Medical device manufacturers should comply with the updated standard to ensure credibility of clinical trials, including proper patient safety and scientific conduct. Further, it will be important to ensure compliance with the new standard when designing forthcoming MDR clinical trials. In addition, manufacturers will need to consider whether other standards and/or country or regional requirements also apply to medical device(s) under investigation. In the case that differences in requirements exist, the most stringent guidelines should be applied.
Moreover, while this standard does not apply to in vitro diagnostic medical devices, there may be situations, dependent on the device and national or regional requirements, where manufacturers might consider whether specific requirements of this document could be applicable.
Partner with a regulatory expert
Choosing a partner that has extensive regulatory expertise and can assist in conducting clinical trials according to ISO 14155 and EU MDR standards — at any stage of clinical development — allows device developers to perform international medical device clinical trials that generate clinical data with integrity. With extensive regulatory knowledge, a CRO can help to navigate today’s constantly changing regulatory landscape and accelerate regulatory approval.
To learn more about ICON’s Medical Device & Diagnostics Research regulatory expertise contact us.
For further info on how regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety, please visit https://www.iso.org/.
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel