IVD Training Courses | IVDR Training

IVDR Training and IVD Compliance Programmes for Your Team

Need your IVD team confident with the new regulatory landscape? We deliver tailored IVD training programmes covering EU IVDR compliance, classification under the new rules, performance evaluation, technical documentation, and the transition from the IVD Directive. Whether your team works in regulatory, quality, or product development, we’ll build a programme around your specific diagnostic products.

EU IVDR Classification, Performance Evaluation, and Transition Training

The shift from the IVD Directive to the EU IVDR has brought fundamental changes to how IVDs are classified, assessed, and maintained on the market. Our team training programmes cover the practical implications of these changes — including the new classification rules, the role of notified bodies for higher-risk IVDs, performance evaluation requirements, and the transition timelines your team needs to be working to. We can also cover companion diagnostics, software as a medical device (SaMD), and the intersection of IVDR with other regulations. For teams working across both IVDs and medical devices, our medical device regulatory training and PRRC training programmes cover the MDR-side requirements and can be combined into a single programme.

IVD Training Built Around Your Diagnostic Product Portfolio

Generic IVD training doesn’t account for the wide variation in product types and risk classes across the diagnostic industry. We tailor our programmes to your specific portfolio — whether you manufacture Class A self-test devices or Class D high-risk IVDs — so your team learns what’s directly relevant to their products. Browse our upcoming IVD course dates or get in touch to discuss IVD training for your organisation.