SaMD templates written from the Notified Body side of the table.

EU MDR applies when software is intended for a medical purpose — defined by your intended purpose in labelling, instructions for use, and promotional material. General-purpose tools are out of scope; software that processes patient-specific data to support clinical decisions usually is. The first step is a written qualification and classification rationale before any technical documentation work begins.

Rule 11 of MDR Annex VIII classifies software that provides information used for diagnostic or therapeutic decisions. Most SaMD falls into Class IIa or higher depending on the severity of the clinical decision and the population affected. Rule 11 is not a bright-line test — classification depends on intended purpose, clinical context, and how directly the output drives decisions. AI-enabled software that generates patient-specific outputs is almost always in scope.

Under MDR Article 15, manufacturers must have a PRRC with the required qualifications and professional experience. Micro and small enterprises are not required to employ the PRRC; they may have the PRRC permanently and continuously at their disposal rather than employed (Article 15(2)).

Most AI-enabled medical devices that need a Notified Body are high-risk AI systems under Article 6(1) and Annex I of the AI Act. After the Digital Omnibus on AI (Regulation (EU) 2026/1744), those obligations apply from 2 August 2028. If your device is MDR-regulated and uses AI, you will face dual compliance under both frameworks. The good news: mature MDR documentation covers much of the foundation — but data governance, human oversight, and transparency requirements need explicit attention.

Timelines vary by device class, NB workload, and documentation quality. Class IIa SaMD commonly takes 12–18 months from submission to certificate, but poor preparation — especially weak classification rationale, incomplete IEC 62304 evidence, or gaps in clinical evaluation — adds months of query cycles. A thorough self-check before you file, e.g. with the free Top 25 SaMD Findings checklist, is the highest-leverage step.

Start with the SaMD Classification Kit if your class isn’t settled. Your technical documentation depends on it. If you already have a defensible class, go straight to the SaMD Technical Documentation Kit, or get the bundle.

No template can guarantee certification. The kits are guidance written from an assessor’s perspective. You stay responsible for your documentation.

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.

Yes, to businesses across the EU and beyond. EU businesses with a valid VAT number are reverse-charged.

Yes, for a limited number of projects. I offer specialist support on classification, Notified Body questions and deficiency lists, technical documentation reviews, AI/ML-specific MDR questions and cybersecurity. Email mikkel@mibb-regulatory.eu with your device and stage, and I’ll reply in writing about whether I can help.