Archived Webinar

Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices

Recorded on February 22, 2022

Manuel Martin
MSc, (MedRadPhys), BiomedSc
Quality & Regulatory Management

While the industry has been preparing for some time, the next few months will be critical for the May 2022 date of application. Manufacturers of legacy devices will have to be keenly aware of how the IVDR will affect their plans and processes. The labelling requirements for the Unique Device Identifiers (UDI) are a significant hurdle on their own, as UKCA marking will also play a role for companies with a strong European presence outside of the EU. This featured presentation will be led by Celegence’s Joseph-Richardson Larbi, who will also be available afterwards for a live Q/A. In this session you will hear key insights into the technical documentation specifications with special attention to legacy devices, the labelling requirements, and what to consider when managing an RA team working towards IVDR compliance.

This webinar will cover:
• The obligations of manufacturers of legacy devices for IVDR compliance
• Reclassifications under the IVDR
• An in-depth breakdown of the labelling and UDI requirements for CE marking IVD products
• The impact that the UKCA marking requirements will have on your process and plans
• The IVDR best practices for navigating the regulations and maintaining market access well beyond the date of application

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Sponsored By:
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Presenters:

Emily M. Headshot

Manuel Martin
MSc, (MedRadPhys), BiomedSc
Quality & Regulatory Management

Experienced Quality and Regulatory Professional with strengths in people motivation, coaching and mentoring multicultural teams, offering over 20 years’ experience in the global medical device space, pharmaceutical and biomedical sectors, including MDD-MDR, IVDD- IVDR and Notified Body expertise.

Skilled people leader and mentor, with high performing multi-site team skills, partnering with regulatory experts around the world to develop and deliver Quality and Regulatory strategy in the support of business portfolios. Experience in tailoring all adjacent business functions to align with corporate strategic goals, whilst maintaining compliance with internal and global requirements.

For More Information, Contact:

Brooke AkinsBrooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693
bakins@q1productions.com​