THREE KEY POINTS ON DEVICE ADVERSE EVENT REPORTING

The breast and hip implant scandals resulted in a flood of lawsuits against medical device manufacturers, governments facing cost related to device replacements, but also in enhanced attention to the proposed changes on the Medical Device Directives and to postmarket surveillance.

More and more postmarket surveillance is handled through postmarket clinical trials. However, the concerning European regulatory landscape for such medical device studies – that to me includes registries -, is an enormous tangle of standards, guidances, directives, and regulations. This can easily lead to unintended inconsistencies in recording and reporting of adverse events. Especially when multiple sites in different countries are participating in a postmarket trial, safety reporting can become very challenging.

These Postmarket Trial AE reporting slides can help guide through this tangle.

The three key points to take into account:
1. National legislation should be followed – verify current local National Competent Authority and Ethics Committee requirements
2. The study sponsor has overall responsibility for adequate safety reporting – ensure external as well as internal alignment regarding adverse event and incident recording and reporting
3. The study protocol is the core document for any trial – include adverse event definitions and reporting processes to be followed, so that all involved are aware.

Please feel free to contact me in case you want to exchange thoughts regarding the above or otherwise.

About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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4 Responses to THREE KEY POINTS ON DEVICE ADVERSE EVENT REPORTING

  1. Thank you Annet for posting.

  2. Israel Madera says:

    I like your three key points summary. Are any of them transferable to the US market?

    • Hello Israel,
      Thank you for your question. Indeed you can transfer the 3 key points to US clinical trials, but the requirements in the US are much more homogeneous than in Europe. So basically number 2 and 3 are the most relevant in such situation, unless you are talking about a global trial that includes European sites.
      Annet

  3. Pingback: EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED | Medical Devices Clinical

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