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Episode 28  |  26:46 min

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

Episode 28  |  26:46 min  |  11.07.2019

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

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This is a podcast episode titled, Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations. The summary for this episode is: Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year. This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe. The new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant. Today we’re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He’s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies. Some of the topics you’ll hear about today include: ● An overview of what’s happening in Europe as far as MDR and IVDR. ● How these changes are impacting the burden of clinical evidence. ● How the periodic reporting regulations are changing. ● Richard’s thoughts on whether the EU regulatory processes will become more like the FDA processes. ● Whether there will be changes on how medical and in-vitro devices are classified. ● How software and technology is playing into the decisions made to change some of the regulations. ● Economic influences and impacts that have affected some of the changes.
Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year. This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe. The new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant. Today we’re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He’s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies. Some of the topics you’ll hear about today include: ● An overview of what’s happening in Europe as far as MDR and IVDR. ● How these changes are impacting the burden of clinical evidence. ● How the periodic reporting regulations are changing. ● Richard’s thoughts on whether the EU regulatory processes will become more like the FDA processes. ● Whether there will be changes on how medical and in-vitro devices are classified. ● How software and technology is playing into the decisions made to change some of the regulations. ● Economic influences and impacts that have affected some of the changes.

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