Human medical devices: MDR training: curriculum and assessment

Audience and preparation

This curriculum is for people preparing or reviewing evidence for human medical devices intended for the European Union market. Before enrolment, identify the product's intended purpose, economic-operator role and the existing route or classification question. Device manufacturers, distributors and quality-system staff need different tasks. The course concerns the MDR context; in-vitro diagnostic products require their separately applicable route. An ISO 13485 certificate is not a substitute for a product-specific conformity assessment.

Learning sequence and expected records

Modules connect intended purpose and role responsibilities to classification reasoning, applicable requirements, technical documentation and supporting clinical or performance evidence as relevant. They locate applicable general safety and performance requirements, risk and clinical-evaluation records, and UDI or registration questions for the route. Preparation, independent assessment and post-market information remain distinct tasks. The learning output is an evidence-planning map, with named responsibilities, missing records and questions requiring specialist review. The course does not make clinical claims or assign a classification solely from a marketing name, and it does not presume that every route involves the same notified-body work.

Planning exercise

A hypothetical device business enrols a design engineer and a distribution manager. Plan separate tasks from the same product description. The engineer must relate design evidence to the stated purpose and configuration; the distribution manager must identify the documents and checks relevant to its operator role. Use a controlled documentation index and an anonymised distribution record. A single ISO-system quiz cannot assess both tasks. The learner must explain the boundary of each role and escalate an unresolved route question instead of inventing a legal conclusion to complete the exercise.

Assessment and role limits

Assessment checks the responsibility map, applicability of evidence and treatment of unresolved technical or regulatory questions. Agree the learner's background, relevant product scope and authorised learning records before scheduling. Kayra can teach agreed documentation and preparation topics. Course completion is not a notified-body decision, competent-authority approval or permission to place a device on the market. The manufacturer and other operators retain their applicable responsibilities, and any required independent assessment remains with the properly selected body.

Official references

• Official references — European Commission
• Official references — EUR-Lex