MDR Medical Device Regulation Training: scope guide

Learning focus

Connect medical-device classification with technical evidence and regulatory responsibilities through a case.

Skills and exercises

• Device intended purpose and classification
• Technical evidence structure
• Medical-device responsibility mapping

Practical learning evidence

• Classification rationale exercise
• Technical-file evidence checklist
• Responsibility mapping worksheet

Prepare for the training

Bring a device description, intended purpose and available technical documents for the practical exercise.

Use an anonymised case to practise the following: medical-device responsibility mapping.

Match training to the participant’s role

For MDR Medical Device Regulation Training, define the learning objective, existing experience and the work participants must perform afterwards. Confirm prerequisites, programme scope and examples before choosing dates or delivery format.

Prepare practical learning evidence

Use relevant process documents, cases and exercises to connect the subject with work. Agree whether the programme includes an examination or another assessment and what completion actually demonstrates.

Clarify time, cost and the outcome

Participant numbers, delivery method and tailored exercises affect planning. State what attendance, completion or an assessment record means; taking a course alone does not establish organisational certification or independent auditor authority.