MDCG 2020-13 and CER Template — Reference Material
This folder contains faithful markdown transcriptions of two external reference documents that guided the post-BSI Round 1 restructuring of our Clinical Evaluation Report (R-TF-015-003). The documents themselves are third-party material reproduced here solely as internal working reference; authoritative copies are the PDFs committed alongside this page.
The folder is named MDCG-2020-01 because the PDF uploaded here is filenamed MDCG-2020-01.pdf — but the PDF's actual content is MDCG 2020-13 (Clinical Evaluation Assessment Report template, July 2020). That is what has been transcribed under mdcg-assessment/. The folder name is retained to match the filename for provenance, not as a claim about the document identity.
MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software) is a different document — it is the source of the three-pillar evidence framework (VCA, Technical Performance, Clinical Performance) that the CEP sets and the CER reports against. The authoritative MDCG 2020-1 PDF lives in the QMS at applicable-standards-and-regulations/04-eu-medical-devices/Guides/04-g07-mdcg-2020-1-clinical-evaluation-mdsw/, and split-part working copies are at round-1/item-0/MDCG-2020-1/. MDCG 2020-1 itself is not transcribed in this folder; if a future BSI round needs section-level quoting of MDCG 2020-1, the same sub-agent conversion pattern used here should be applied to that PDF.
What lives here
| Reference | Source PDF | Purpose | Markdown folder |
|---|---|---|---|
| MDCG 2020-13 — Clinical Evaluation Assessment Report template (July 2020) | MDCG-2020-01.pdf (folder name retained from upload; document is MDCG 2020-13) | The EU notified-body CEAR template — what BSI uses to score our CER. Sections A–K. | mdcg-assessment/ |
| Free CER Template (Mantra Systems, Edition 2) | CER Template.pdf | A fully-worked MDR-compliant CER structure — what a compliant CER should contain and in what order. 14 numbered sections. | cer-template/ |
Why markdown (and not just the PDF)?
- Searchable and quotable: every assessment criterion and template heading is now addressable by URL/anchor, so the CER, the BSI response docs, and the coverage matrix can link to exact paragraphs.
- Diffable: when MDCG or Mantra issue updates, we can diff the markdown to see exactly what changed.
- CI-verifiable coverage: the
coverage-matrix.mdxat the Round 1 root cross-references every section heading here to a CER anchor; a CI script fails the build if any link rots.
Conversion notes
- Automated PDF → markdown pipelines were tried and produced unusable output on landscape-oriented tables (MDCG §C/§D) and the benefit-risk formula (CER §10). Content here was produced by Claude Code sub-agents, one per section, each reading the source PDF pages directly and writing a single output file following a shared conversion contract (GFM pipe tables, escaped fill-in fields, KaTeX math, footnotes preserved).
- Exact wording has been preserved. Cross-references (e.g. "Section F", "Annex II") were not rewritten to relative links during conversion — the later Phase B refactor links them.
- Each file starts with
# Section …followed by an italic provenance line*Source: <pdf> pages X-Y*.
How this folder relates to BSI Round 1
The BSI Round 1 findings (items 1–7) identified structural and traceability gaps in the existing CER. Phase A of the remediation is this reference conversion; Phase B restructures the CER in place so every MDCG 2020-13 section, every CER Template section, and every BSI finding maps to a verifiable anchor in R-TF-015-003.