Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

1.0 RAC Credits Member: $0 NonMember: $25

This is an on-demand recording from the May 2022 event

This event is brought to you by:

The EU IVDR is the biggest regulatory change impacting diagnostics in Europe and it has arrived in full force. With a date of application of 26 May 2022, its implementation has not without challenges. Time did almost run out before an amendment to the transition timelines resulted in a progressive roll-out of the regulation.

A lot has happened since June 2020, when notified bodies issued the first IVDR certificates. From increased post-market surveillance requirements to QMS audits and technical documentation assessments, there have been several lessons learned which will shape the future of the regulation for years to come.

In this webcast, a former notified body leader and industry subject matter experts will discuss the new IVDR timeline step by step, as well as outline key lessons learned from the early phases of IVDR implementation.

The presentation will also shine light on the most contentious topics under the IVDR. We will be taking a deep dive into the intended purpose statement, which is creating several challenges for global registrations and will also reflect on clinical evidence requirements for both legacy and new IVDs following the recent publication of MDCG 2022-2.

Finally, the presenters will uncover key regulatory hurdles around special types of products, including companion diagnostics, near patient tests, in-house developed tests & Class D devices to name a few, with a special mention of SARS-CoV-2 IVDs which have dominated headlines during the pandemic.

Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.

Learning Objectives;

After this program, participants will:

Understand the impact of the new IVDR timeline on their product portfolio and plan accordingly
Anticipate potential notified body feedback by reflecting on lessons learned in several areas from intended purpose, clinical evidence, and post-market surveillance requirements
Understand expectations and the increased scrutiny mechanism for special types of products, from companion diagnostics to Class D devices
Be able to prepare for the future of the IVDR and adapt their transition strategy accordingly

Instructors:

Carlos Galamba, RQM+

Kristen Meany, RQM+

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Questions

Contact the RAPS Solutions Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org

Add to Cart

Discover more of what matters to you

No taxonomy

Member Knowledge Center

RAC Spotlights

Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

Learning Objectives;

Cancellation Policy

Questions

Discover more of what matters to you

News »

Books »

Learning »

Events »

Member Knowledge Center

RAC Spotlights

Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

Learning Objectives;

Cancellation Policy

Questions

Find more

Discover more of what matters to you

News »

Books »

Learning »

Events »