An “in vitro diagnostic medical device” (IVD) is a medical device, reagent, instrument or software, which is intended to be used in vitro for the examination of specimens derived from the human body, for diagnostic purposes. These diagnostic tests may provide information concerning a pathological disease or a predisposition to a medical condition or disease, but may also predict treatment response or reactions.
IVD tests may be performed in clinical laboratories, while devices for “near-patient testing” are intended to be carried out by healthcare professionals outside of a laboratory environment. Self-testing devices are another category of IVDs, intended to be used by lay persons.
With healthcare systems driving for greater efficiency and sustainability, IVD tests are providing information necessary to increasingly focus on prevention, early intervention and disease treatment. Consisting of diagnostic tests performed at hospital or private clinical laboratories, near-patient testing and self-tests, the IVD market is expected to continue to grow at a steady pace within a substantially more stringent international regulatory environment.
Key challenges encompass:
- Product qualification/classification
- Market clearance route
- Safety and Efficacy claims
- Risks analysis and risk management plan
- Performance evaluation (including clinical utility)
- Quality Management System
- Market access strategy and value demonstration to payers
Science-based, global product development strategy and planning
- Position product and claims
- Assist in innovative product classification and development plans
- Develop roadmaps towards international market approvals (EU, US, Australasia, South America)
- Advise on/conduct regulatory bodies strategic, and product development meetings (Notified Bodies, EU Competent Authorities, FDA)
- Assist with risks analysis and risk management plan
- Develop and submit regulatory files (EU CE mark Technical File, US 510k & PMA, De novo Canada, Australasia, South America)
- Optimize quality and vigilance systems
- Advise on labeling and advertising