MDCG Pre-Registration Assessment study materials
MDCG Pre-Registration Assessment study resources

MDCG Pre-Registration Assessment exam-day guide

MDCG Pre-Registration Assessment · Prepare for the day ahead.

Your checklist

Government-issued photo ID

Bring the original ID document in the name you registered with. Check in advance which ID types the provider accepts and whether a second form is required; confirm with the provider rather than assuming a passport or national ID alone is sufficient.

Admission ticket or appointment confirmation

Print or download the confirmation showing your test date, time, and location or remote-testing link. Save an offline copy in case network access fails on the day.

Confirmed test format and platform requirements

Confirm with the provider whether the assessment is delivered on paper, at a test centre, or via remote proctoring, and what software or browser is required. Do not rely on second-hand accounts of the format.

Approved reference material, if any

Determine from the provider whether any regulatory texts, guidance documents, or notes are permitted and in what form. If the rules are not clearly stated, confirm with the provider; assume nothing is allowed until confirmed.

Permitted calculator or stationery

Check the provider's list of allowed items. If the exam involves any quantitative or timeline reasoning, confirm whether a basic calculator, scrap paper, or pen is supplied or must be brought.

Travel and arrival plan

Plan to arrive with a buffer before the reporting time; late arrival rules vary and can result in refused admission. For remote testing, plan a quiet room and a backup internet connection.

Remote-testing environment check

If testing remotely, run the provider's system check on the same device and network you will use. Confirm room-scan, webcam, microphone, and desk-clearance requirements with the provider.

Personal items plan

Know where phones, watches, bags, and notes must be stored. Most providers prohibit them at the desk; confirm storage arrangements before travelling.

Break and timing expectations

Confirm with the provider whether breaks are scheduled, optional, or unavailable, and whether the clock stops during them. This affects pacing across the assessment.

Scoring and results information

Confirm the pass standard, score reporting timeline, and any resit policy directly with the provider. Do not rely on forum claims about cut scores.

Access arrangements, if applicable

If you have approved accommodations, bring the confirmation letter and confirm the logistics with the provider ahead of time; arrangements are usually not granted on the day.

Review scope against the published syllabus

Use the provider's published content outline to confirm which topic areas are in scope. Where the outline is ambiguous, confirm with the provider rather than guessing.

Plan the day

Final 72 hours

Stop expanding your materials. Work through the provider's content outline and mark each area as confident, shaky, or unknown. Spend the remaining time only on shaky areas, using short active-recall passes rather than rereading. Rehearse the structure of a regulatory assessment answer: identify the applicable framework, state the classification or route, justify it against the criteria, and note documentation and post-market obligations. Confirm logistics: reporting time, address or link, ID requirements, and permitted items.

Final 72 hours (practical)

If the assessment involves reading device descriptions or clinical evidence summaries, practise extracting the decision-relevant facts quickly: intended purpose, duration of contact, invasiveness, active versus non-active, and whether a companion diagnostic or medicinal substance is involved. Time yourself on a small set of practice scenarios so you know your pace per question.

24 hours before

Do a light review only: classification rules, conformity-assessment routes, and the structure of key documentation. Prepare and lay out your ID, confirmation, and any permitted items. Check travel times or run the remote platform check once more. Set two alarms. Avoid last-minute cramming of unfamiliar material, which tends to displace consolidated knowledge.

Morning of the test

Eat and hydrate normally. Arrive at the reporting time with buffer, or log in early for remote testing. Leave phones and notes where the provider requires. Read the instructions on the paper or screen carefully, including any statement about negative marking or question navigation, before starting.

During the test

Do a first pass answering questions you can resolve quickly, flagging the rest. For scenario questions, identify what is actually being asked before choosing an option: classification, conformity route, documentation, or post-market action. Eliminate options that cite the wrong framework or overstate an obligation. Return to flagged items with remaining time and check that you have answered every question if there is no penalty for guessing. Confirm the submission process before leaving or closing the session.

Rules to check

  • Bring the original ID in the registered name; copies and expired documents are commonly refused. Confirm accepted ID types with the provider before the test day.

  • Arrive or log in at the stated reporting time. Late arrival may result in refused admission or reduced time; confirm the provider's late-arrival policy in advance.

  • Do not bring unauthorised materials, notes, or electronic devices to the desk. If you are unsure whether an item is permitted, confirm with the provider and leave it out until confirmed.

  • Follow all proctor and invigilator instructions, including room scans and desk clearance for remote testing. Non-compliance can lead to invalidation of your result.

  • Breaks, if any, follow the provider's rules; confirm whether the clock stops and whether you may leave the testing area. Unauthorised breaks may not be accommodated.

  • Scoring and the pass standard are set by the provider. Confirm the reported score, pass mark, and any resit or appeal process directly with them rather than relying on third-party accounts.

  • If a technical failure occurs during a remote test, notify the proctor immediately and follow the provider's incident process; do not attempt to resolve it independently.

  • Report any suspected error in the question paper or platform to the invigilator or proctor rather than guessing silently, and confirm afterwards how such reports are handled.