Clinical Evaluation Documents under EU MDR – in Depth Review
Wednesday, 29 March 2023
| 08:00-09:00 | Registration |
| 08:50-09:00 | Introduction Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland |
| 09:00-10:30 | Regulatory Overview of the Clinical Evaluation Process |
| – Review of EU regulations regarding Clinical Evaluation (EU-MDR and related guidance documents) – Before starting a clinical evaluation plan – how does risk management relate? – When to start the clinical evaluation process in new product development Course lead: Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland |
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| 10:30-11:00 | Coffee Break & Networking |
| 11:00-12:30 | Develop a Comprehensive Clinical Evaluation Plan (CEP) |
| – Contents of a clinical evaluation plan – Quantified claims (safety, performance and clinical benefits) – Position your device – Available data and preparing meaningful literature search protocols and appraisal plans Course lead: Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland |
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| 12:30-14:00 | Lunch Break & Networking |
| 14:00-15:00 | Write your Clinical Evaluation Report (CER) |
| – Clinical Development Plan – Contents of a clinical evaluation report – Analysis of the different data sets – Discussion and conclusions – What’s next – the PMCF Plan and PMS plan Course lead: Danielle Giroud, CEO MD-CLINICALS, Switzerland & Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland |
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| 15:00-15:30 | Coffee Break & Networking |
| 15:30-17:00 | Develop PMCF Plan and Other Documents |
| – Contents of a Post Market Clinical follow up plan (PMCF) – How to determine PMCF activities – an overview of the different options – Other documents such as Summary of Safety and Clinical Performance (SSCP) – for users and SSCP for patients Course lead: Danielle Giroud, CEO MD-CLINICALS, Switzerland & Elina Buitrago, PhD (Medical Writer), MD-CLINICALS, Switzerland |
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| 17:00 | End of workshop |
