01

Define the real file before requesting a quotation

Provide manufacturer and sites, intended purpose, justified class, model and variant comparison, materials, software, manufacturing and available technical/clinical evidence. Identify whether the task is gap review, preparation, external testing or notified-body assessment. A quotation based only on the model count does not describe the actual work and decision dependencies.

Example: two versions share a housing, but one is sterile and uses a different patient-contact material. Identify the actual configurations and existing reports before assuming one file covers both. Scope, sterilisation evidence and body involvement must be resolved for the real versions; do not price an unresolved family as already accepted.

02

Distinguish preparation, external assessment and evidence gaps

Quote intended-purpose and classification review, GSPR mapping, document organisation and coordination separately from laboratory work, clinical-evaluation tasks, notified-body charges and production corrections. Agree who supplies samples, complete reports and manufacturer data. Clinical investigation is not an automatic universal package; the actual requirements and evidence gaps determine the necessary next work.

If the supplied report concerns another material, software revision or use condition, first decide what it actually supports. Record missing or contradictory evidence and arrange appropriate technical evaluation. Additional review or testing may change cost and sequence. A paid preparation service cannot guarantee that a laboratory, notified body or competent authority accepts the proposed evidence.

03

Plan readiness, changes and work after the first decision

Use separate milestones for scope and classification, complete documentation, implemented controls, necessary evidence generation, external assessment and responses to findings. Manufacturer readiness and body availability affect the sequence. Include ongoing post-market work and change control in the scope discussion; they are not completed by purchasing one certificate or entering a registration record.

Example: after the initial file review, the proposed label adds a new patient population not covered by the clinical evaluation. Stop treating the old file as complete; assess the changed purpose, risks and evidence before continuing. Update the remaining tasks and responsibilities. Kayra cannot promise a fixed total price, favourable certificate decision or guaranteed completion date for an unresolved device file.

04

Responsibility

Kayra supports the scope note, evidence plan and assessment coordination. It does not claim notified-body or accredited laboratory status and does not guarantee a positive result or fixed certificate date. Manufacturer and required assessment-body duties remain separate. This guide addresses the EU/EEA route; national market and operation rules need their own check.

Official sources

Reviewed: 3 October 2026. Check the current rules and assessment route for the actual product.