Clinical Evaluation according to EU MDR 2017/745
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
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.
€229
VAT calculated at checkout
13 modules · 3h 23 · workbook
· certificate
Access does not expire
Most clinical evaluations fail on structure, not on science
A plan written after the data, describing what was found rather than deciding what was needed. A state of the art section built from papers about your own device. An analysis written as a narrative, with nothing mapping to a requirement.
None of these are failures of clinical knowledge. They are failures of structure — and structure is teachable.
This course follows the process in the order the work actually runs, and ends where the work ends: with the file somebody else assesses.
- 13 modules
- 3h 23 of video
- Self-paced
- Workbook included
- Certificate on completion
- Access does not expire
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
Outcomes
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.
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.
What is included
What you get when you buy
- 13 video modules, 3h 23 in total
- A downloadable transcript for every module
- A test at the end of each module, and a final test
- The gap analysis workbook, as a PDF
- A certificate with a verifiable code
- Every future revision of the course, at no further cost
The certificate
On passing the final test the certificate carries a 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 ISO 13485 §6.2.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
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 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 — and that list maps to the templates in the Clinical Evaluation Kit.
Clinical Evaluation
13 modules, 3h 23 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€229.00
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