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Course Details

In Vitro Diagnostics Requirements: General safety and performance requirements

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

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Course Details

The IVD industry is facing significant change. The new European In Vitro Diagnostic Regulation (IVDR) entered into force on May 25 2017, marking the start of the transition period for manufacturers selling IVD devices into Europe.

The IVDR (2017/746/EU), which replaces IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

The impact of the changes for manufacturers must be clearly understood, and robust, timely plans should be put in place to ensure a smooth transition over the next five years. The General Safety and Performance Requirements (SPRs), Annex I, are a critical section of the IVDR that all manufacturers must understand.

ALL IVDs need to meet the SPRs; new IVDs and existing CE-marked IVDs will need to comply with these requirements by 26 May 2022.

This webinar will discuss the implications of the new IVDR on manufacturers, and highlight some key points of note for manufacturers as they plan for the transition to the new Regulation.

Presenter

Erica Conway is the Global Head of IVDs at BSI. Having joined BSI at the beginning of 2014, Erica is using her experience to transition the Notified Body to the IVD Regulation.

Erica has over 14 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance.

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