Article 61 · Annex XIV · Annex XV
Clinical Evaluation according to EU MDR 2017/745
From the plan that decides what has to be demonstrated, to the report somebody else assesses — and everything that has to hold in between.
Scope
What the course covers
Where a requirement is quoted, it is quoted in full and then explained. Where something is an interpretation rather than a rule, the course says so.
01
The regulation
Article 61 in full, Annex XIV Parts A and B, Annex XV, and the general safety and performance requirements of Annex I that need clinical support.
02
The guidance
MDCG 2020-5 on equivalence, MDCG 2020-6 on legacy devices and sufficient clinical evidence, MDCG 2020-1 on medical device software, and the assessment template notified bodies use.
03
The standards
The ISO 10993 series where it supports biological equivalence, and ISO 14155 for clinical investigations.
Outline
13 modules, in the order the process runs
The course follows the sequence of the work rather than the numbering of the regulation, and ends where the work ends.
Introduction
What the course covers, and how it worksRequirements, guidance and definitions
Where the rules live, what the words meanThe clinical evaluation plan
Annex XIV Part A §1(a)State of the art
The benchmark the device is judged againstIdentification and appraisal of clinical data
Search protocol · two-axis appraisalAnalysis of clinical data
Per requirement, and the benefit-risk determinationClinical equivalence
Annex XIV §3 · Article 61(4) and (5)Legacy devices and sufficient clinical evidence
MDCG 2020-6 · Article 61(6)(a)Clinical evaluation of medical device software
MDCG 2020-1 · three componentsArticle 61(10): the route without clinical data
When clinical data is not appropriateThe Clinical Evaluation Report
And what the notified body does with itClinical investigation
Articles 62–80 · Annex XV · ISO 14155Clinical evaluation and PMCF
Annex XIV Part B · closing the loopFinal test
Covering the whole courseOutcomes
What you will be able to do
01
Write a plan that decides in advance
What has to be demonstrated, and how much evidence is enough — with benefits stated as parameters somebody could measure.
02
Build a state of the art that works
At the level of the condition, with its own search protocol, and use it to set your acceptability criteria.
03
Appraise on both axes and analyse per requirement
Methodological quality and relevance kept separate, and a conclusion for each GSPR.
04
Read your report the way a reviewer will
Using the same assessment template they use.
Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every module replayable. Transcripts are downloadable, so the content stays searchable long after the video is finished. Access does not expire, and revisions made after your purchase are included.
Audience
Who the course is for
- Regulatory and clinical affairs professionals
- Medical writers preparing clinical evaluation reports
- The person responsible for regulatory compliance
- Consultants preparing files for manufacturers
It assumes familiarity with medical device regulation and with a quality management system. It does not assume prior study of the articles and annexes it covers.
Certificate
Verifiable by a third party
On passing the final test, the certificate carries a verification code derived from your name and the date of completion.
An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under your quality system.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you enrol
Does it cover legacy devices transitioning to the MDR?
Yes, in a dedicated module built on MDCG 2020-6: the hierarchy of clinical evidence, what sufficient means for a device already on the market, and how to present historical post-market data so that it counts.
Is software covered?
Yes, in a dedicated module on MDCG 2020-1 — including where clinical evaluation ends and software verification and validation begins, which is the distinction that costs manufacturers the most review time.
Does it teach me to run a systematic literature review?
It teaches what the regulation requires of one, how the output is judged, and what makes a search reproducible. It is not a course in research methodology.
Is the course live, or can I start whenever I want?
It is self-paced. You start when you buy it and work through it at your own speed, from any device. There are no scheduled sessions and no cohort.
How long do I have access?
Access does not expire. The course is tied to your account, and modules updated after your purchase are available to you at no additional cost.
Do I have to finish it in one sitting?
No. Progress is saved to your account, so you can stop in the middle of a module and resume where you left off.
What does the certificate confirm?
That you completed the course and passed the final test. It carries a verification code derived from your name and the date, which anyone can check on a public page. It can be filed as training evidence under your quality management system.
What happens if I do not pass a test?
You can take it again. The rules for each test are shown on screen before you start it.
Is the workbook included?
Yes. It is a gap analysis of your own documentation, arranged in the order an assessment runs, and it is designed to be worked through alongside the modules rather than read afterwards.
Can my company buy several seats?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook included with the course is a gap analysis of your own documentation, arranged in the order an assessment runs. Working through it produces a list of what is missing or partial in your file.
That list maps to the templates in the Clinical Evaluation Kit.
Enrol
Clinical Evaluation
13 modules, 3h 23 of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.