01

Start with intended purpose and justified classification

Identify the actual manufacturer, device models, intended purpose, users, patient population, use duration and contact with the body. Keep the label, instructions, promotional claims and clinical evaluation consistent. Apply MDR scope and Annex VIII classification to these real characteristics; a commercial device name or the requested certificate price cannot determine its class.

Document the rule and its rationale before choosing the conformity assessment route. Distinguish ordinary Class I manufacturer declaration from the limited notified-body involvement for sterile, measuring or reusable surgical Class I devices and the relevant routes for other classes. Do not assign a class or exemption merely from resemblance to another product.

02

Connect GSPR and clinical evidence to the actual model

Map the applicable general safety and performance requirements, or GSPR, to controlled design, risk, verification, validation and clinical-evaluation evidence. Explain nonapplicable requirements. Link each report to its model, material, software version and configuration where relevant. A laboratory report or ISO 13485 certificate alone does not demonstrate all MDR duties or clinical performance.

Hypothetical example: a patient-contact component changes polymer, but the supplied biological report describes the old material. Compare composition, contact conditions and actual use; identify the unsupported conclusion and obtain justified technical review or additional evidence. Do not mark the gap closed because the two models share a trade name. Existing clinical literature also requires demonstrated relevance to the actual purpose.

03

Separate manufacturer duties, body decision and registration

The manufacturer maintains the technical documentation, risk and clinical evaluation, production controls, declarations and post-market processes. Where a notified body is required, verify its actual device/activity scope before application. Its assessment and certificate decision are distinct from Kayra’s contracted preparation; neither the consultant nor a general management-system certificate replaces that role.

Check the actual certificate, device scope, declaration and label before market use. UDI and EUDAMED registration are separate duties, not a substitute for conformity assessment or permission for another model. Review design, manufacturing and claim changes against the applicable route. CE for one assessed device does not approve every future variant or give blanket permission in every non-EU market.

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.