EU IVDR Performance Evaluation Kit
€399.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU IVDR · Annex XIII · Annex III · MDCG 2022-2
EU IVDR Performance Evaluation Kit
Three reports, one evaluation, and the post-market loop that closes it — the evidence architecture the IVDR requires and the MDR does not have.
€399
VAT calculated at checkout
11 Word templates · Annex XIII Part A and B
Instant download · free updates
The IVDR splits what the MDR keeps together
A medical device has one clinical evaluation report. An in vitro diagnostic has three: scientific validity, analytical performance and clinical performance — assembled into a performance evaluation report that assesses them rather than summarising them.
Manufacturers arriving from the device side rebuild that architecture by trial and error, usually twice: once from the text of Annex XIII, and again after a notified body explains what MDCG 2022-2 expects. The IVDR guide sets out where this sits in the wider framework.
This kit is that architecture, already built. The plan carries the thirteen elements of Annex XIII 1.1 with the literature search protocol inside it, where the guidance puts it. The report carries the six elements of 1.3.2 with an assessment against each. Every document ends with a checklist against the provision it satisfies.
- 11 Word templates
- Annex XIII Part A and B
- Annex III post-market
- MDCG 2022-2
- MDCG 2025-10
- Free updates
Contents
Eleven templates across the evidence lifecycle
Sources
Written against the guidance, not only the Regulation
01
MDCG 2022-2
The evidence architecture: what each pillar establishes, which sources it may rest on, and why the search protocol belongs inside the plan.
02
MDCG 2025-5 and 2024-4
Performance studies: the routes under Articles 58 and 70, what counts as interventional, and safety reporting under Article 76.
03
MDCG 2025-10 and 2022-9
Post-market surveillance across both regulations, and the summary of safety and performance for class C and class D devices.
Audience
Who the kit is for
- Manufacturers of class B, C and D devices facing a performance evaluation for the first time
- Manufacturers whose IVDD-era file has to be rebuilt into the three-report structure
- Devices self-certified under the Directive that now need evidence a notified body will read
- Regulatory and clinical affairs teams moving from clinical evaluation to performance evaluation
- Consultants running several IVDR performance evaluations in parallel
What is included
What you get when you buy
- 11 Microsoft Word templates, editable and unlocked, with no macros
- Compliance checklists against Annex XIII 1.1, 1.2, 1.3 and Annex III in the relevant documents
- The hazard and benefit-risk framing an IVD needs, where harm is indirect
- Cross-references between the plan, the reports and the post-market documents
- Cover page, revision history and approval table on every document
- Instant download after purchase, and free updates for regulatory and guidance changes
Questions
Before you buy
Does the kit generate clinical data?
No. The templates structure and assess the evidence; they do not create it. A device without analytical performance studies will still need them — the Regulation admits no alternative for that pillar.
Do I always need clinical performance studies?
Clinical performance may rest on studies, peer-reviewed literature, or published experience from routine diagnostic testing. Studies are the default, and the other two require a justification recorded in the plan before the data are collected.
Is this the technical file?
No. The performance evaluation sits in Section 6.2 of Annex II, and the surrounding file is the EU IVDR Technical Documentation Kit. The Annex II guide shows how the two fit together, and the Complete Bundle carries both.
Does it cover class A and class B devices?
Yes. The performance evaluation applies to every class. What changes is the update frequency and the periodic report: class A and B produce a post-market surveillance report under Article 80, class C and D a PSUR under Article 81.
Is the summary of safety and performance included?
Yes, with all three templates from MDCG 2022-9 rev. 1: professional users, patients and lay persons, and devices intended for self-testing. It applies to class C and class D devices.
Can I reuse my MDR clinical evaluation template?
The concepts map, the references do not. See the clinical evaluation guide for the MDR side. Article 61 becomes Article 56, Annex XIV becomes Annex XIII, and Annex XIV under the IVDR means interventional performance studies — a copied cross-reference points somewhere else without giving an error.
What format are the files in?
Microsoft Word, fully editable, no macros and no protection.
Do I get updates?
Yes. The MDCG guidance in this area moves; updates are provided free of charge to existing customers.
EU IVDR Performance Evaluation Kit
11 Word templates covering Annex XIII Part A and Part B, the Annex III post-market documentation and the summary of safety and performance. Instant download, free updates, no expiry.
€399.00
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