Regulatory navigation for software-enabled medical devices.

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. For many start-ups and scale-ups, a full-time hire is not practical — fractional PRRC coverage lets you meet the legal requirement with a named, qualified person on your documentation without adding a permanent headcount.

From August 2026, high-risk AI system obligations apply to AI-enabled medical devices that fall under Annex III. If your device is MDR-regulated and uses AI, you likely 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. Submission readiness review before you file is the highest-leverage step.

The earlier the better for classification and regulatory strategy — getting the intended purpose and class right before development locks in saves significant rework. For documentation and NB preparation, engage when you have a defined device and target market. For PRRC, engage before you need a named person on your declaration of conformity.

Every engagement has defined outputs — not open-ended consulting hours. Typical deliverables include classification rationale memos, technical files aligned to MDR Annex II/III, QMS procedures, NB submission readiness reviews, query response support, and fractional PRRC coverage. Scope, timeline, and deliverables are agreed before work starts.

Yes. MiBB Regulatory is based in Copenhagen and works with manufacturers across the Nordic region and the wider EU. All consultancy is delivered in English; Danish is also available. Remote collaboration is standard — most clients are outside Denmark.