Request Readiness Review

Submission requirements

See what a reviewer will ask you for.

Pick your product category and target region. This is the evidence structure DSRV works from, section by section, with the regulation or guidance behind every line. No account, no upload, no readiness grade.

Product category

Submission region

Only the regions listed above have a published checklist for medical devices today. Ask DSRV if you need another region.

Medical devices · European Union (EMA / national)

8 sections · 22 evidence items

Citations are regulatory anchors for orientation, not an exhaustive or binding checklist. DSRV's reviewer confirms applicability to your specific product and submission type.

  1. Section 01

    Device Description & Classification

    • EU MDRRegulation (EU) 2017/745 Annex II §1; Annex VIII classification

    • Device description and intended purpose

    • Classification rationale (Annex VIII rules)

    • UDI / Basic UDI-DI information

  2. Section 02

    General Safety & Performance Requirements

    • EU MDRMDR Annex I — GSPR checklist with evidence mapping

    • GSPR checklist with evidence references

    • Harmonised standards / common specifications applied

  3. Section 03

    Risk Management

    • ISOISO 14971; MDR Annex I Chapter I

    • Risk management file / analysis

    • Benefit-risk determination

  4. Section 04

    Verification & Validation

    • EU MDRMDR Annex II §6 — product verification and validation

    • Pre-clinical / bench test reports

    • Biocompatibility evaluation (ISO 10993 series)

    • Sterilization validation (if applicable)

    • Software lifecycle evidence (IEC 62304, if applicable)

  5. Section 05

    Clinical Evaluation

    • EU MDRMDR Article 61 + Annex XIV — clinical evaluation

    • Clinical evaluation report (CER)

    • Clinical data / literature evidence

  6. Section 06

    Post-Market Surveillance

    • EU MDRMDR Articles 83–86 — PMS system, plan and reports

    • Post-market surveillance plan

    • PMCF plan (or justification of non-applicability)

  7. Section 07

    Labelling & IFU

    • EU MDRMDR Annex I Chapter III — information supplied with the device

    • Label copy

    • Instructions for use

  8. Section 08

    Submission Readiness Review

    • DSRVDSRV submission-readiness review gate

    • Completeness checklist

    • Missing items

    • Reviewer comments

    • Client action items

    • Readiness status

What happens next

Nothing here needs a document from you

This list is the starting structure, not a verdict on your programme. Evidence only moves into a private, engagement-scoped workspace after confidentiality scope is agreed, and a DSRV reviewer confirms which items actually apply to your product.