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Episode 36  |  31:54 min

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36  |  31:54 min  |  11.07.2019

What Devicemakers Need to Know About Medical Device Reporting (MDR)

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This is a podcast episode titled, What Devicemakers Need to Know About Medical Device Reporting (MDR). The summary for this episode is: Medical device reporting, or MDR: what is it? What isn’t it? Why is it important? The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. Mike is a frequent guest on our show and really knows just about everything there is to know about medical device reporting. Sit back and enjoy today’s episode of the Global Medical Device podcast. Some of the highlights of the show include: ● Why the 2016 FDA guidance on MDR is so important to post-market surveillance. ● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects. ● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs. ● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events. ● Why the FDA is putting out this new guidance now, even though the process has been around for a long time. ● Who counts as a manufacturer in terms of the FDA guidance. Mike answers whether dentists, hospitals and physicians must report problems according to the letter of the law vs. the spirit of the law. ● How reprocessors fit into the reporting requirements. ● Mike’s thoughts on why medical device reporting might eventually become a moot point.
Takeaway 1 | 00:15 MIN
Over-reporting vs. Under-reporting
Medical device reporting, or MDR: what is it? What isn’t it? Why is it important? The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. Mike is a frequent guest on our show and really knows just about everything there is to know about medical device reporting. Sit back and enjoy today’s episode of the Global Medical Device podcast. Some of the highlights of the show include: ● Why the 2016 FDA guidance on MDR is so important to post-market surveillance. ● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects. ● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs. ● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events. ● Why the FDA is putting out this new guidance now, even though the process has been around for a long time. ● Who counts as a manufacturer in terms of the FDA guidance. Mike answers whether dentists, hospitals and physicians must report problems according to the letter of the law vs. the spirit of the law. ● How reprocessors fit into the reporting requirements. ● Mike’s thoughts on why medical device reporting might eventually become a moot point.

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