What is an IVD medical device?

An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”

The definition then outlines the principle or sole purpose of these devices. Under the IVDR, an IVD medical device must have a medical application or purpose. For more clarity on the definition of IVD medical devices, please refer to the IVDR (EU) 2017/746.

Our IVD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer CE certification services for IVD medical devices under the EU IVDR and UKCA certification under the UK MDR (2002).

SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in London, UK.

Medical Devices and IVD

The MDR implementation last May has highlighted issues within the industry that need to be addressed and the upcoming IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance.

The conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these regulations. In addition, the conference will consider the evolving regulatory landscape for digital health software.

Advantages of IVD

IVDs can help prevent health problems from worsening.

IVDs can spot early warning signs and individual risk factors, creating new opportunities for prevention and early intervention. Some IVDs extend beyond the laboratory, hospital or doctor’s office, empowering patients with chronic diseases to self-monitor and manage their own conditions.

Delivering value that far outweighs risk

While IVDs support clinical and personal decision making, they do not directly drive health outcomes. Unlike other medical devices that provide therapy, most IVDs never even come into contact with patients.

Considered the “silent champion” of healthcare, IVDs are extremely valuable resources for disease prevention, detection and management. They influence roughly two-thirds of clinical decision making while accounting for just 2% of healthcare spending. As an industry – manufacturers, healthcare professionals and regulators alike – we must not understate or overlook the power of IVDs in the fight against disease worldwide.