MDCG Pre-Registration Assessment study plan

Map the structure of MDR 2017/745 article by article, writing a one-line purpose statement for each chapter and annex from memory after a closed-book pass.

Distinguish the roles and legal responsibilities of economic operators (manufacturer, authorised representative, importer, distributor) and state who carries which obligation under Articles 10-14.

Trace how MDCG guidance documents are produced, endorsed and published, and explain their legal status relative to the Regulation text.

Compare MDR and IVDR scope, definitions and transitional provisions in a two-column table covering at least ten divergence points.

Locate and summarise the MDCG guidance most relevant to pre-registration assessment, noting for each the document number, issue date and the assessment question it answers.

Explain how MDCG position papers and Q&A documents are used by notified bodies and competent authorities when the Regulation text is ambiguous.

Reproduce the classification rules of MDR Annex VIII for the classes most often disputed, and justify a classification decision for three worked device examples.

Identify where MDCG guidance has been superseded or amended and describe how to verify you are reading the current version.

Apply the MDR Annex VIII classification rules to at least 15 practice devices spanning Classes I, IIa, IIb and III, and record the decisive rule for each.

Match each device class to its conformity assessment route under Articles 52 and Annexes IX, X and XI, including when a notified body is mandatory.

Explain the Class I carve-outs (sterile, measuring function, reusable surgical instruments) and why they pull a device into notified body involvement.

Describe the notified body's role in the pre-registration phase: application, scoping, quotation, and the boundary between assessment and certification.

Reconstruct the Annex II technical documentation structure and state what evidence satisfies each section for a representative Class IIb device.

Explain the role of the GSPR checklist (Annex I) and how each GSPR is evidenced, including the standards presumption of conformity under Article 8.

Draft the pre-registration submission package checklist a notified body expects, covering application form, declaration, technical documentation and classification rationale.

Identify the common causes of pre-registration deficiency letters and describe how to pre-empt each in the submission.

Outline the clinical evaluation process under Article 61 and Annex XIV, including the equivalence route and when it is defensible.

Distinguish clinical evaluation, clinical investigation and PMCF, and state the documentation each produces.

Explain the performance evaluation requirements under IVDR Article 56 and Annex XIII, including scientific validity, analytical performance and clinical performance.

Summarise the content and purpose of the clinical evaluation assessment report (CEAR) and how notified bodies use it in the pre-registration dialogue.

Build the PMS system per Article 83 and Annex III, listing the inputs, outputs and review cadence for each PMS element.

Explain the vigilance workflow under Articles 87-92, including serious incident reporting timelines, trend reporting and field safety corrective actions.

Design a PMCF plan under Annex XIV Part B that specifies methods, endpoints, sample size rationale and linkage to the clinical evaluation.

Describe how PSUR and periodic safety update requirements differ by device class and what triggers an update.

Map ISO 13485:2016 clauses to MDR Annex IX quality system requirements and flag the clauses that need MDR-specific extension.

Apply ISO 14971 risk management to the fictional device, producing a hazard analysis with risk acceptability decisions and residual risk justification.

Explain supplier controls: selection, evaluation, monitoring and the written agreement requirements for critical suppliers and subcontractors.

Describe UDI assignment under Article 27, the Basic UDI-DI concept, and how device data is entered and governed in EUDAMED.

Integrate all prior deliverables into one coherent pre-registration dossier for the fictional device and check internal consistency across classification, clinical, PMS and UDI sections.

Re-read the guidance register from week 2 and state, for each document, exactly where it shaped a decision in the dossier.

Complete a timed 60-question mock assessment weighted by domain percentage and score at least 75 percent.

Review every mock question answered incorrectly and write a corrected one-sentence rule for each.