Module 5 Presentations

16/07/2024

Medical Device Clinical Trials

Clinical Investigations (CI) PostMarket Clinical Follow-up (PMCF)

Eur. Ing. Neil R Armstrong, BSc CEng MIET FTOPRA FRAPS Mariona Casals, BSc, MSc.

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Content

1. Introductions 2. Regulatory (EU-MDR) 3. UK-MDR / NHS

MDR Recital (64) clinical investigations should be in line with well-established international guidance such as ISO 14155:2011 on GCP for clinical investigations of medical devices so the results of EU clinical investigations can be accepted outside the Union and vice versa. In addition, in line with the most recent WMA Declaration of Helsinki.

The Organisation for Professionals in Regulatory Affairs

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