Cruxi
Service decision and evidence guide
MDR Article 15 distinguishes a manufacturer’s internal PRRC from the permanent, continuous availability arrangement allowed for qualifying micro and small enterprises. It separately addresses authorised representatives. Check the actual organisation and evidence of expertise before deciding that an external service fits.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · EU
| Decision or task | What the source describes | What to prepare |
|---|---|---|
| Which qualification route is evidenced? | Article 15(1) describes relevant formal qualifications plus at least one year of relevant experience, or four years of relevant experience; it separately describes custom-made expertise. [1] | Check the proposed person against the applicable route, including national professional-qualification provisions. |
| Internal person or external availability? | Article 15(1) says within the manufacturer organisation; paragraph 2 permits a different arrangement for qualifying micro and small enterprises, with permanent and continuous availability. [1] | Document enterprise eligibility and how continuous access, absence and urgent decisions will work. |
| What tasks are assigned? | Article 15(3) covers release conformity checks, current technical documentation/declaration, post-market obligations, reporting and the investigational-device statement where relevant. [1] | Match each applicable responsibility to records and access; split joint responsibilities in writing as paragraph 4 requires. |
| Does representation settle manufacturer responsibilities? | Article 15(6) addresses the representative’s own PRRC arrangement; Article 11(4) restricts delegation of manufacturer obligations. [1] [2] | Scope the manufacturer and representative roles separately before accepting a combined quotation. |
Eligibility, device context and evidence of actual availability remain incomplete. A directory listing is not evidence of qualification or a compliant PRRC arrangement.
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Check the proposed person against the applicable route, including national professional-qualification provisions.
Useful evidence: Qualification documents, dated experience and covered device responsibilities.
Document enterprise eligibility and how continuous access, absence and urgent decisions will work.
Useful evidence: Enterprise-size assessment, availability commitments, backup and escalation plan.
Match each applicable responsibility to records and access; split joint responsibilities in writing as paragraph 4 requires.
Useful evidence: Release/document/reporting responsibility matrix and access permissions.
Scope the manufacturer and representative roles separately before accepting a combined quotation.
Useful evidence: Two role descriptions with covered entities and deliverable ownership.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
Thu, 10 Sep 2026 17:31:54 GMT · retrieved 2026-10-06
Source key D05 · snapshot fd42f74592a6a3ac614be3505c16b24acc814c725637749534fcbff0c5d411d6
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.