What is the IVD-R? What’s changing, why and when
How do labs implement molecular tests to meet complex clinical needs?
Laboratories around the world have different options for implementing diagnostic tests. In our educational resources we describe different diagnostic assays and explain why they are important for laboratories in clinical, hospital, and academic settings. We also review regulations that must be understood by IVD (in vitro diagnostic) manufacturers and laboratories that offer in-house developed assays (IHAs) or in-house devices (IHDs).
Keep your lab current and innovative, and explore our educational resources to discover more on:
- IVD tests* and in-house devices (IHDs): differences and challenges
- The typical IHD process and development timeline
- Intellectual property associated with diagnostic tests in the European Union
- IVD-R: What’s changing and the impact on in-house assay providers
Introduction to testing: a closer look at IVDs and IHDs
An introduction to diagnostic testing types in European laboratories**
Abstract
- Description of the different types of in vitro diagnostic (IVD) tests
- Identification of differences between an in-house device (IHD) and an IVD test
- The benefits of running IHDs and IVD tests
- Examples of IHDs and different applications for them
Differences between an in-house device (IHD) and an in vitro diagnostic (IVD) test
Implementing an in-house test
Preparing for and implementing an in-house test**
Abstract
- Discover how a laboratory can prepare to design and implement an in-house test
- The typical steps of an in-house device (IHD) implementation and key questions that must be addressed at each stage of the process
Typical IHD process from discovery to launch (more details can be found in the paper)
Opportunity identification
Business and functional requirements
Optimisation phase
Establish performance
Design lock
Ensure intended use
Supply chain setup
Design transfer through regulatory clearance
Regulatory documentation and support
Opportunity identification
Business and functional requirements
Optimisation phase
Establish performance
Design lock
Ensure intended use
Supply chain setup
Design transfer through regulatory clearance
Regulatory documentation and support
Intellectual property
Intellectual property associated with diagnostic tests in the European Union**
Abstract
- Discover the options for protecting intellectual property associated with IVD tests and IHD, including those that rely on existing technology or known biomarkers
- Potential avenues for biomarker patent protection under current patent law
- Steps that an organisation can take to understand the patent landscape for a particular test
Simplify the development and implementation of diagnostic testing in European laboratories
Continue your educational journey with this on-demand webinar discussing how clinical labs can establish in-house assays to meet complex needs.
In Vitro Diagnostic Regulation (IVDR)
Watch video presentations on IVDR, delivered by Anna Sadio, EMEA Regulatory Affairs Manager, Thermo Fisher Scientific.
*For simplification we are using the term "IVD assay" to describe CE-IVD assays and "IHD" to describe in-house developed IVD assays throughout the papers
** Educational papers authored by
Mara G. Aspinall, MBA, Managing Partner, Health Catalysts Group; Professor of Practice and Co-Founder Biomedical Diagnostics Program, Arizona State University
Michael Donovan, PhD, JD, Managing Partner, MJD Consulting; Lecturer, Biomedical Diagnostics, Arizona State University
Marilyn Owens, PhD, MBA, Managing Partner, Medical Laboratory Strategy and Leadership, LLC
Style Sheet for Global Design System