Is IVDR Wearing You Down? A Webinar Reviews 2022 for IVD Manufacturers

IVDR 2022: The Year In Review Webinar with IVD Insider Carlos Galamba

Is the In Vitro Diagnostic Regulation (IVDR) wearing you down? If so, you’re not alone. 

No matter how you look at it, 2022 has been a tumultuous year for the in-vitro diagnostics industry leaving many industry stakeholders asking, “How did we get here?” and, “Where is all this headed?”

To be sure, 2022 has been a year of great regulatory change, but also one of significant learning and growth.

Huma.AI, a leading innovator in Regulatory Intelligence solutions, is pleased to host a new webinar, “IVDR 2022: The Year In Review,” featuring Carlos Galamba, VP of Intelligence and Innovation, RQM+, on Wednesday, December 14 at 11:00 am EDT. During the 45-minute webinar, Galamba will discuss some of the significant events, milestones, and top guidance documents of the past twelve months and what to expect in 2023 and beyond.

(Note: This live webinar will also be recorded and made available to all registrants.)

Taking Stock: How Did We Get Here?

IVDR is a set of rules and guidelines that are used to regulate the production and use of medical devices and tests that are used to diagnose diseases and conditions in a laboratory setting.

Beginning with the approval of the IVDR transition in late 2021, and continuing up to an assessment of the current workload and suggested timelines for “getting it all done,” the webinar featuring Galamba will cover the following:

• Implications of IVDR transition by device class
• Current notified body capacity and timelines
• The top IVDR guidance docs and templates
• Prioritizing your IVDR workload
• Tallying the cost of IVDR compliance 

Plus, expect a look at the most recent news from Switzerland and the EU Commission, as well as what to anticipate in 2023.

IVDR is straining the industry by introducing new requirements and challenges that must be met to achieve compliance. This is proving costly and time-consuming, requiring significant changes to be made industry-wide. 

Some of the most significant changes include:

• Increased regulatory oversight: IVDR introduces new requirements for the evaluation, registration, and certification of IVD products. This means that manufacturers, distributors, and users of IVD products must comply with a range of new rules and guidelines in order to ensure that their products are safe, effective, and accurate.
• New classification categories: IVDR introduces new classification categories for IVD products, which are based on their level of risk and complexity. This means that different products will fall into different categories, and they will be subject to different requirements and regulations.
• Clinical trials and performance evaluations: IVDR requires manufacturers of certain IVD products to conduct clinical trials and performance evaluations in order to demonstrate the safety and effectiveness of their products. This can be costly and time-consuming, and it may require manufacturers to make significant changes to their production processes and quality control systems.

In short, IVDR is causing significant changes in the IVD industry while creating new challenges and opportunities for manufacturers of IVD products.

Attend the webinar to get an insider's view on how IVDR's implementation has played out in 2022 and what to expect going forward.

Who Should Attend

• Regulatory and Quality Professionals
• Medical Writers
• IVD Industry Consultants 
• Other In Vitro Diagnostic Stakeholders 

About the Speaker

Carlos Galamba is a veteran IVD insider and Vice President, Intelligence and Innovation with RQM+. Prior to joining RQM+, Galamba served as a technical reviewer, technical team manager, and clinician with BSI, a notified body. Before BSI, Galamba worked as a lead scientist with the National Health System in the UK, working in transfusion medicine.

About the Sponsor

Huma.AI is a leading provider of human-centric business intelligence for life sciences, including medical affairs, regulatory affairs, and clinical development software. A venture-backed AI startup based in Seattle, Huma.AI was co-founded in 2018 by CEO Lana Feng, Ph.D., and CTO Greg Kostello, to bridge the gap between scientific data and life science decision-making.