IVDR compliance for IVD software and digital diagnostics

Software used only for storage, communication, workflow administration, general laboratory management or simple result display may fall outside the IVDR when it does not create or modify medical information.

Qualification is product-specific. Asteron structures the rationale and identifies points that require regulatory, scientific, laboratory or notified-body input. The legal manufacturer remains responsible for the final regulatory position.

Classification is based on the intended purpose and the rules in Annex VIII of the IVDR. It cannot be assigned solely from the technology used or from a competitor’s classification. Software that combines several functions must be assessed against the function with the highest applicable class.

These three elements are documented through a Performance Evaluation Plan and Performance Evaluation Report. The evidence must be updated through post-market surveillance and post-market performance follow-up rather than treated as a one-time submission.

The final deliverables depend on the product, classification and available evidence. Laboratory testing, clinical performance studies, biostatistics, scientific literature reviews and other specialist activities are included only when expressly stated in the proposal.

Each standard addresses part of the evidence system. Certification to one standard does not, by itself, demonstrate complete IVDR conformity.

The IVDR creates a common European regulatory foundation, but successful deployment also depends on national laboratory practice, procurement, language and health-data requirements.

For the Netherlands, manufacturers should consider IGJ oversight, Dutch laboratory and hospital procurement expectations, local labelling needs and NEN 7510 where health information is processed. NEN 7510 supports Dutch health-information security but does not replace IVDR conformity.

For Germany, the applicable authority and additional process may depend on the type of diagnostic product and issue involved. Manufacturers must also plan for German-language information, laboratory integration, local procurement and any separate reimbursement pathway. IVDR conformity does not automatically establish reimbursement eligibility.

A single controlled IVDR evidence base should support the European product. National requirements should be handled as traceable market extensions rather than separate and potentially conflicting product files.

Some devices previously placed on the market under Directive 98/79/EC may use extended transition periods, but only when all applicable conditions are met. Transition is not automatic and does not permit unrestricted changes to the device or its intended purpose.

The current final placing-on-the-market dates are:

New devices and Class A non-sterile devices not covered by transitional provisions must comply with the IVDR. Eligibility also depends on previous conformity status, QMS implementation, timely notified-body application and agreement, absence of significant design or intended-purpose changes and continued acceptable safety.

Asteron can establish the agreed management processes, organise the evidence, coordinate specialists and prepare the organisation for assessment. Asteron cannot act as both implementation partner and independent conformity-assessment body.

Where notified-body involvement is required, the client selects and contracts the notified body separately. Its application, assessment, travel, certification and surveillance fees are quoted independently and paid directly to that organisation.

The same applies to laboratories, clinical performance studies, scientific or biostatistical specialists, authorised representatives and external testing unless the proposal expressly includes them. Asteron does not publish a generic third-party fee range.