On-demand

IVDR 2022: What IVD manufacturers can learn from the MDR rollout (On-Demand)

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This is an On-demand recording from December 2021

IVD manufacturers are expected to face many challenges during the transition to compliance with the EU’s new requirements for IVDS, the IVDR.

This webcast will discuss the potential impact of the IVDR on new and existing (legacy) devices and important considerations for determining an appropriate regulatory pathway and application strategy.

May 2022 is closer than we think and IVD manufacturers in the EU market have a lot to do in preparation for the 26 May 2022 IVDR date of implementation, as most will no longer be able to rely on market access with the current IVDD certificate. The new reality for manufacturers includes facing additional scrutiny by EU Notified Bodies and Competent Authorities, installing a Person Responsible for Regulatory Compliance (PRRC) and carrying out additional testing and performance investigations.

This webcast will cover these major themes of the IVDR with actionable information on tackling the most important requirements. Specific topics to be covered include:

• What the IVD community can learn from the regulatory developments stemming from the MDR and what the IVD community can learn from this. 
• Key elements of the IVDR and areas on which to focus when implementing takeaways from the MDR rollout. 
• The performance evaluation process and documentation requirements.
• How to review and effectively implement IVDR requirements into technical dossiers and QMS. 
• How to integrate risk management and postmarket surveillance into the QMS. 
• Management of the implementation of the IVDR project.

Learning Objectives:

At the conclusion of this program, attendees will understand:

• the most important developments from the MDR and how these may impact implementation of the IVDR.
• how to monitor and consider regulatory developments when developing your IVDR strategy for your QMS and technical dossier.
• how to develop a sound regulatory approach for your compliance under the new regulation.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

Regulatory affairs professionals (specialists, managers, and directors)

Instructors:

Alex Laan currently holds the position of principal consultant at NAMSA. Previously, he worked as principal certification manager at DEKRA Certification BV, a notified body for in vitro diagnostic (IVD) medical devices, located in the Netherlands. Laan also has worked at KEMA Quality, where he was lead assessor for medical devices and IVD devices, and device specialist reviewer in IVDs and medical devices, including drug-device combinations. He is an active member of the IVD working group within EU notified bodies and TEAM-NB, and acts as direct contact for EU competent authorities.

Laan’s educational background is in bioprocess technology and biochemistry engineering. He has worked as a product specialist in immunohematological and plasma products with Sanquin Blood Transfusion Services, Amsterdam, and as a quality assurance and regulatory affairs manager for IVD medical devices at Meddens Diagnostics/IBL, Hamburg.

Questions

Contact the RAPS Support Center:

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