Speaker to be announced

ePoster winner

Requirements for clinical evidence from the buyer's perspective

Navigating reimbursement

Financing Clinical Investigations: Options & Strategies

Notified body's perspective to IVD performance studies

Designing and Executing an IVD Clinical Performance Study

Evidence generation in post market phase

Case example: clinical evaluation of a software medical device

European Health Data Space (and implant registries) update

Entering the U.S. Market: Clinical & Regulatory Pathways

Successful Patient Recruitment: Tools & Best Practices

What Makes or Breaks a Clinical Investigation?

Data management in medical device clinical investigations and utilization of eSystems

Reorganisation of Regulation

Finnish regulatory landscape based on market surveillance

How does the competent authority collaboration benefit you?

Emerging standards and regulation for AI

AI adaptation and evolvement under medtech regulations

Manufacturer voice - IVDR CE-marking vs other target markets?

Utilization of AI in post-market surveillance

AI Act - notified bodies vs FDA

Next level medical device conformity assessment

Cybersecurity

Security risk management in medical devices

Sufficient cybersecurity evidence - practical apporach

Panel discussion at Market Square: In-house tests

This lecture reviews what is required to ensure that home pregnancy tests are reliable and fit for purpose, whether used in a laboratory setting or by lay users. Relevant considerations include how the formats of devices are described, description of the isoforms of human chorionic gonadotrophin recognised and the units of measurement, as well as specimen requirements. Assessment of analytical accuracy, sensitivity and reproducibility must be carefully undertaken and clearly defined in technical data sheets. Assessment of clinical accuracy should provide users with information about how accurately the test will identify pregnancy status and clear definition of how that pregnancy status is defined. Advantages and potential disadvantages of highly sensitive home pregnancy tests will be discussed. As home pregnancy tests are developed primarily for lay users who generally will have little practical experience of laboratory testing, clear instructions, robust methods and straightforward interpretation of the results are essential. Results from the UK National External Quality Assessment Service (UK NEQAS) Pregnancy Testing scheme provide some evidence as to how well these requirements are fulfilled in practice.