MDCG Pre-Registration Assessment study guide
MDCG Pre-Registration Assessment · Work through your exam, one topic at a time.
The MDCG Pre-Registration Assessment is an independent study credential for professionals preparing to submit medical device or IVD documentation under the EU MDR 2017/745 and IVDR 2017/746. It targets regulatory affairs specialists, quality managers, notified body reviewers, consultants, and clinical/performance evaluation staff who need to demonstrate command of the pre-registration phase: classifying devices, selecting conformity assessment routes, assembling Annex II/III technical documentation, planning clinical or performance evaluation, and applying MDCG guidance. The MDCG Pre-Registration Assessment study guide has 8 sections and about 5,026 words.
01EU Medical Device Regulatory Framework: MDR, IVDR and the MDCG Guidance Structure
This domain tests whether you can place any device question inside the correct legal instrument and separate binding law from interpretive guidance. In a pre-registration assessment you are expected to cite the article or annex that creates the obligation, and to know which economic operator carries it.
419 words, about 2 min02Device Classification under MDR Annex VIII and IVDR Annex VIII
Classification drives everything downstream: the conformity assessment route, the depth of technical documentation review, PSUR frequency and UDI deadlines. The exam tests whether you can apply Annex VIII rather than recite a list of rules.
466 words, about 2 min03Conformity Assessment Routes and Notified Body Involvement
The conformity assessment route determines how much of the technical documentation a notified body actually reads, so errors here propagate into every later part of an assessment. Class I devices that are non-sterile, have no measuring function and are not reusable surgical instruments are self-certified: the manufacturer draws up technical documentation to Annexes II and III and issues an EU declaration of conformity under Annex IV.
456 words, about 2 min04Technical Documentation: Annex II, Annex III and Retention
Technical documentation is the object of the assessment. The exam tests whether you know what Annex II actually requires, how Annex III differs, and how long the file must survive.
409 words, about 2 min05Annexes and Pre-Registration Submission Requirements
Pre-registration assessment is the gate before a notified body accepts an application. The exam tests whether you know which annex supplies each document and what an incomplete submission looks like.
433 words, about 2 min06Clinical Evaluation: Article 61, Annex XIV Part A and Equivalence
Clinical evaluation is where most pre-registration files fail. The exam tests whether you can construct a defensible evidence route under Article 61 and Annex XIV Part A rather than assert that a literature review was performed.
417 words, about 2 min07Clinical Investigation and Performance Evaluation Requirements
Investigations and performance studies are the evidence route used where a manufacturer cannot rely on literature or equivalence. The exam tests the regulatory mechanics and the difference between MDR investigations and IVDR performance studies.
359 words, about 2 min08Post-Market Surveillance, Vigilance and Post-Market Clinical Follow-Up
Post-market obligations are examined at pre-registration because a device cannot be certified without a functioning PMS system already described. The exam tests timelines and the difference between the PMS plan, the PMS report, the PSUR and the vigilance report.
2,067 words, about 10 min