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 component test is offered for a finished medical device with a different intended use. Compare configuration and test conditions with the device's risk and clinical evidence needs. Prepare a gap list linking the missing claim to its evidence, and show how new post-market information would reopen the relevant risk question.

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. QRS can deliver the agreed training and exercises within its stated training role. 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