EU MDR 2017/745 · Annex I · Annex II, Section 4
GSPR Checklist under the EU MDR: How to Complete It
Annex II asks for four things on every requirement of Annex I: whether it applies and why not, the method, the standard or other solution, and the document that proves it. This short course works through the GSPR checklist column by column, on the Excel template you receive with it.
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
Applicability
Where Annex I states the condition that makes a section apply — in its opening words or in the heading of its section — and how to write a reason for No that names a characteristic of the device.
02
Standards and evidence
How to check that a standard is harmonised under the MDR and in which edition, what its Annex ZA covers, when a common specification is binding, and the four elements of a precise evidence entry.
03
A complete table
The four statuses and what each requires, the difference between partial applicability and partial status, the link to the risk management file, and six closing checks, each a filter and a count.
Outline
4 lessons, 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.
GSPR and Annex I
Article 5(2), Annex I, Annex II Section 4, Articles 8 and 9Applicability
Yes, No, Partial, and the reason for every NoStandards and evidence
Method, reference, edition, document, locationA complete table
Status, notes, and the six closing checksFinal test
Covering the whole courseOutcomes
What you will be able to do
01
A device profile
Twelve questions answered once, from the intended purpose, that decide which blocks of Annex I apply.
02
A reason for every No
Each one stating a characteristic of the device and the condition in Annex I it does not meet.
03
A citation for every applicable row
The standard with its edition and the clauses applied, or the other solution with its justification.
04
An evidence entry anyone can follow
Document code, revision, title and location in the technical documentation.
05
A table ready to file
A status on every row and six closing counts at zero, recorded in the revision history.
Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every lesson replayable. Access does not expire, and revisions made after your purchase are included.
Audience
Who the course is for
- Regulatory affairs specialists preparing technical documentation under the MDR
- Quality engineers asked to own the GSPR checklist
- PRRC who sign off the technical documentation
- Consultants and start-up teams building a first technical file
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
Is the template included?
Yes. The Excel template is part of the purchase: the download link arrives with the order confirmation and stays available under My Account, Downloads.
Do I need copies of the harmonised standards?
Not for the course. You will need the standards you apply to fill your own checklist, and the course shows how to check their edition and what their Annex ZA covers.
Does the course cover the IVDR?
No. It is built on Annex I and Annex II of the MDR. The method transfers to the IVDR, but the sections and their conditions are different.
How long do I have access?
Access does not expire. The course stays in your account, including any updates made to the modules after your purchase.
Is there a certificate?
Yes. Passing the final test issues a certificate with a verification code, which anyone can check on our verification page.
Can I watch the modules in any order?
The modules unlock in sequence, because each one builds on the previous. Once unlocked, a module stays available and can be rewatched.
Do I need any prior knowledge?
The course assumes you work in the sector and know what a technical file and a notified body are. No knowledge of the specific technology is assumed.
Can my company buy several seats?
Yes. Write to us and we will set up team access with a single invoice.
Enrol
From the first applicability decision to the six closing checks — on the template itself.
4 lessons, 40 minutes of video, the GSPR Checklist Excel template, a test after each lesson and a certificate. Self-paced, with no expiry.