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The clinical component is crucial under MDR, IVDR, and UK Medical Devices regulations as it provides the evidence needed to demonstrate that a medical device or IVD is safe, performs as intended, and delivers meaningful clinical benefit—ensuring patient safety and regulatory compliance throughout the product lifecycle.
Our transparent and reliable conformity assessments enable efficient clinical evaluations. Our experts bring extensive experience, undergo rigorous training, and maintain active clinical practice to ensure safe and practical device assessments. This allows us to meet our full code designation of all types of devices from diagnostics to therapeutic, including cosmetic devices per Annex XVI. For high-level discussions on evidence of conformity, assessment procedures, QMS, or complex clinical, technical, and regulatory approaches, request a BSI Structured Dialogue.
These insightful webinars will help you focus on various aspects of the MDR, from looking at post-market clinical follow-up to when a clinical evaluation is required and to supporting you with preparing a Clinical Evaluation Report.
Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.
