The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions

This FAQ document, developed by NAMSA’s In Vitro Diagnostic Regulation (IVDR) experts, discusses the most commonly asked questions regarding IVDR, date of application and implementation procedures and strategies.

Following are just some of the discussion points and questions answered within:

• Will the IVDR date of application be delayed?
• Will there be enough Notified Bodies to manage all devices on the market in 2022?
• How much clinical evidence is considered enough to meet IVDR requirements?
• How does a Manufacturer approach Risk Assessments and ISO 14971:2012 / ISO 14971: 2019?
• How does one address a lack of literature for new IVD products and technologies?
• What does Technical Documentation for Post-Market Surveillance (PMS) entail?

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How NAMSA Can Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for medical device and IVD manufacturers. Ensure your IVDR conformity and get in touch today: namsa.com/locations-contact/. You may also learn about our IVD services and solutions by visiting: namsa.com/services/ivd/.