The EU IVDR: What do you need to know?

The RA QA Café

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۲ سال پیش 54:22

MP3•خانه قسمت

“In regards to the IVDR you have three things that you have to formalize, you have scientific validity, clinical performance and analytical performance. ” – Warren Jameson

Discussion topics include:

What is IVDR?
What is the major change compared to the EU’s In Vitro Diagnostic Directive (IVDD)?
What is the true impact on small, mid-size and large businesses?
Has there been a shift in the time it takes for getting IVDs to market in the EU?

Helpful Links:

• EUR-Lex - 02017R0746-20170505 - EN - EUR-Lex (europa.eu) - Regulation (EU) 2017/746

• MDCG_2022-2_en.pdf (europa.eu) - MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs)

• MDCG 2021-4 en.pdf (europa.eu) – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

• https://www2.namsa.com/RAQA_Cafe_IVDR_Clinical_Evidence

14 قسمت

#Science #Fitness #Medicine #NAMSA

The EU IVDR: What do you need to know?

The RA QA Café

published ۲ سال پیش

اشتراک گذاری

MP3•خانه قسمت

“In regards to the IVDR you have three things that you have to formalize, you have scientific validity, clinical performance and analytical performance. ” – Warren Jameson

Discussion topics include:

What is IVDR?
What is the major change compared to the EU’s In Vitro Diagnostic Directive (IVDD)?
What is the true impact on small, mid-size and large businesses?
Has there been a shift in the time it takes for getting IVDs to market in the EU?

Helpful Links:

• EUR-Lex - 02017R0746-20170505 - EN - EUR-Lex (europa.eu) - Regulation (EU) 2017/746

• MDCG_2022-2_en.pdf (europa.eu) - MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs)

• MDCG 2021-4 en.pdf (europa.eu) – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

• https://www2.namsa.com/RAQA_Cafe_IVDR_Clinical_Evidence

14 قسمت

#Science #Fitness #Medicine #NAMSA

همه قسمت ها

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40:12

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54:22

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