MiBB Regulatory

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Written by a former Notified Body assessor – focused on SaMD and Rule 11.

EU MDR template kits for software medical devices. Six years reviewing MDR software submissions showed me where files fail. Every template is built around those findings and comes with reviewer notes on what an assessor typically checks, so your documentation answers the questions before they are asked.

  • Every template opens with a “What the Notified Body will challenge here” box
  • New in v1.2: reviewer notes in every template – 3–6 notes on what an NB reviewer typically checks, based on public MDR/MDCG guidance
  • Guidance plus structured fill-in fields — delete the guidance, keep the record
  • ISO/IEC standards referenced by clause number only — no copyrighted standard text included
  • Businesses only · company name and VAT ID required · prices excl. VAT · delivered by email after payment

Free download

NB Reviewer’s Top 25 SaMD Findings

The 25 issues I saw most often when reviewing software medical device files — from weak Rule 11 rationales to missing SOUP evaluation and unverified cybersecurity controls. A checklist to run before you submit.

  • PDF + editable Word checklist
  • Grouped by classification, IEC 62304, risk, usability, cybersecurity and clinical
  • Free — delivered by email

MiBB Regulatory ApS (CVR 46526155) uses your details only to send the checklist and, if you opt in, occasional updates. No tracking, no sharing. Unsubscribe or request deletion any time via mikkel@mibb-regulatory.eu.

Template kits

From classification to technical file.

Start with a defensible classification, then build the software documentation set the Notified Body expects.

Launch price

SaMD Classification Kit

€99

excl. VAT · 4 templates

  • R11-01 Software qualification memo (MDCG 2019-11 rev.1 decision steps, AI Act check)
  • R11-02 Rule 11 classification rationale (“worst credible impact” structure)
  • R11-03 Intended purpose statement
  • R11-04 Classification decision checklist
  • Word templates, single-organisation licence
Buy the Classification Kit

For businesses only · Company name and VAT ID required · No refunds after delivery. Guidance templates, no guarantee of certification. Terms of sale · Disclaimer.

Flagship · Launch price

SaMD Technical Documentation Kit

€549

excl. VAT · 12 templates

  • TD-01 Software development plan & TD-02 Software requirements
  • TD-03 Architecture / detailed design
  • TD-04 SOUP / SBOM register (Excel)
  • TD-05 Software safety classification
  • TD-06 Risk management plan + file outline
  • TD-07 Usability engineering plan
  • TD-08 Cybersecurity plan
  • TD-09 GSPR checklist, Annex I (Excel)
  • TD-10 Clinical evaluation plan · TD-11 V&V plan · TD-12 Release notes
Buy the Technical Documentation Kit

For businesses only · Company name and VAT ID required · No refunds after delivery. Guidance templates, no guarantee of certification. Terms of sale · Disclaimer.

Best value · Launch price

Bundle: SaMD Classification Kit + SaMD Technical Documentation Kit

€569

excl. VAT · 16 templates

  • Everything in the SaMD Classification Kit (4 templates)
  • Everything in the SaMD Technical Documentation Kit (12 templates)
  • Classification rationale flows straight into your technical file
  • Save €79 vs. buying both separately (€99 + €549 = €648)
Buy the Bundle

For businesses only · Company name and VAT ID required · No refunds after delivery. Guidance templates, no guarantee of certification. Terms of sale · Disclaimer.

Inside every template

Built from the assessor’s side of the table.

  • Document control and revision history
  • “What the Notified Body will challenge here” box
  • Reviewer notes: what an NB reviewer typically checks or samples in this record, with the public basis (MDR, MDCG, standards by clause number)
  • How-to-use guidance (delete before release)
  • Key references — MDR, MDCG and ISO/IEC by clause number
  • Structured sections and tables with clear placeholders
  • Approval block ready for your QMS

⚠ What the Notified Body will challenge here

Example from R11-02: “The rationale argues Class IIa because a clinician reviews the output — but the intended purpose does not restrict use to trained clinicians, and no evidence shows the output cannot directly drive a treatment decision. Expect a request to justify why the worst credible impact is not ‘serious deterioration’.”

✎ Reviewer notes

Example from R11-02: “Worst credible consequence drives IIa/IIb/III. Reviewers ask what happens to the patient if the output is wrong (false negative and false positive) and check that the severity matches the ISO 14971 file.”

Based on public sources only. Not an NB checklist and not a prediction of any specific Notified Body’s review.

How the kits are made

AI-assisted, expert-reviewed.

I use AI tools to help draft and structure the templates. Every document is then reviewed, corrected and finalised by me, drawing on my background in medical device software engineering and six years as a Notified Body assessor. AI speeds up the writing, but the regulatory judgement is mine.

  • What AI does: helps draft and structure the text. It does not make classification or conformity decisions.
  • What I do: review, correct and finalise every template before release, including checking the MDR and MDCG references against the official sources and the classification and documentation logic against how a Notified Body reviews it.
  • What you do: adapt each template to your own device and make and document the regulatory decisions yourself.

Each template carries the line “Drafted with AI assistance, reviewed by Mikkel Bruus-Borggaard”, and the kit README explains what I checked.

Licence & terms

Simple, business-only licensing.

  • Businesses only: you buy on behalf of a company or other organisation, and you must enter the company name and a valid VAT ID at checkout. We do not sell to consumers. Single-organisation licence: use and adapt the templates within one legal entity and its devices. No resale or redistribution.
  • All prices are in EUR and exclude VAT. EU business buyers with a valid VAT number are reverse-charged at checkout.
  • Delivered by email after payment, normally within a few hours. Free minor updates (v1.x) for 12 months, each with a changelog. Current version: v1.2 (October 2026), with AI Act dates updated for the Digital Omnibus on AI.
  • No refunds after delivery, because digital files cannot be returned. If a file is defective or your kit never arrives, we replace it or refund you.
  • Templates are guidance only, not regulatory advice, and do not guarantee certification or Notified Body acceptance — you remain responsible for your device’s compliance and for checking that the references you rely on are current. Read the full disclaimer and the Terms of Sale & Licence. ISO/IEC standards must be purchased separately; no standard text is reproduced.
  • Questions about the kits or a problem with your purchase? Email info@mibb-regulatory.eu.

Before you buy

Can I buy as a private person?

No. The kits are sold to businesses and organisations only. At checkout you confirm that you are buying for a business and accept our terms.

Do I need a VAT ID?

Yes. Enter your company name and VAT ID at checkout. EU businesses outside Denmark are invoiced without VAT under the reverse-charge rules. Danish businesses pay 25% VAT.

Can I get a refund?

Not once the kit has been delivered, because digital files cannot be returned. If a file is corrupted or doesn’t match the description, or the kit doesn’t arrive, email info@mibb-regulatory.eu and we will replace it or refund you.

How is the kit delivered?

By email to the address you enter at checkout, normally within a few hours.

Will the templates get me certified?

No template can guarantee that. The kits are guidance written from a Notified Body assessor’s perspective. You stay responsible for your documentation and for checking that every reference is current.

Did you use AI to make these templates?

Yes. I use AI tools to help draft and structure the templates. Every document is then reviewed, corrected and finalised by me, drawing on my background in medical device software engineering and six years as a Notified Body assessor. AI does not make classification or conformity decisions, and every template must be adapted to your own device. How the kits are made.

Full details: Terms of Sale & Licence.

Need more than a template? I take on a limited number of specialist reviews and projects for SaMD and AI teams: classification, Notified Body questions and deficiency lists, technical documentation gaps, AI/ML and cybersecurity. See specialist support or email mikkel@mibb-regulatory.eu.

MiBB Regulatory ApS is an independent consultancy. Use of the templates does not guarantee any certification outcome.

Disclaimer

Guidance, not a guarantee.

Applies to all templates, checklists, spreadsheets and guidance supplied by MiBB Regulatory ApS (CVR 46526155, Denmark), including free resources (the “Templates”). The same text is included in every kit as DISCLAIMER.pdf.

  1. Guidance only, provided "as is". The Templates are general guidance tools. They are provided "as is", without any warranty, express or implied, including as to accuracy, completeness or fitness for a particular purpose. They are not legal or regulatory advice.
  2. No guaranteed outcome. Using the Templates does not guarantee any outcome, including acceptance by a Notified Body, a successful conformity assessment, CE marking, certification, or approval by any competent authority or other regulator.
  3. The manufacturer stays responsible. The manufacturer remains solely responsible for its technical documentation, its quality management system and its compliance with Regulation (EU) 2017/745 (MDR), Regulation (EU) 2024/1689 (AI Act) and all other applicable requirements.
  4. Check that references are current. Regulations, harmonised standards, MDCG guidance and other references change. MiBB Regulatory monitors relevant updates and issues new versions of the Templates, but does not warrant that any version is complete or current when you use it. You must verify yourself that every regulation, standard and guidance document you rely on is the current version.
  5. Adapt to your device. The Templates are generic. You must adapt them to your specific device, intended purpose, risk profile and quality management system, and the completed documents should be reviewed by suitably qualified personnel.
  6. No consultancy relationship. Buying or downloading the Templates does not create a consultancy, advisory or other client relationship with MiBB Regulatory. Consultancy services are provided only under a separate written agreement.
  7. Limitation of liability. To the extent permitted by Danish law, MiBB Regulatory's total liability arising from or in connection with the Templates is limited to the price you paid for them. MiBB Regulatory is not liable for indirect or consequential loss, such as lost profit, delayed market access or the cost of additional Notified Body review.

This disclaimer is governed by Danish law and forms part of our Terms of Sale & Licence.