EU IVDR Complete Bundle
€999.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU IVDR · Technical · Performance · Risk
EU IVDR Complete Bundle
The three kits together, already cross-referenced, plus six documents that are not sold anywhere else. Everything a complete IVDR submission needs, in one download.
€999
VAT calculated at checkout
31 templates · Word and Excel
Save €178 · instant download
The three kits were designed to work together
Section 5 of the technical file points at the risk management report. Section 6.2 points at the performance evaluation report. The PMPF plan cites the gaps numbered in that report. The summary of safety and performance draws on all of them.
Bought separately, the documents still fit. Bought together, they arrive already connected — and the six additional templates come with them. The three are also sold on their own: Technical Documentation, Performance Evaluation and Risk Management.
- 31 templates
- 3 kits
- 6 bundle-only documents
- Word and Excel
- Save €178
- Free updates
Contents
What the bundle contains
Bundle only
The six documents you only get here
01
Qualification and Classification Rationale
Annex VIII has seven rules and thirteen indents in Rule 3 alone. This works through all ten implementing rules and every indent, and records the rules considered and rejected as implementing rule 1.7 requires.
02
Technical Documentation Checklist
Word and Excel, 132 elements across Annex II and Annex III, with gap, action, owner and due date columns. It doubles as the remediation plan before submission.
03
PRRC Designation Letter
Article 15 with the correct IVDR references. The duties are Articles 82 to 86 and Annex XIV, not the MDR numbering that most reused letters still carry.
Price
What the arithmetic looks like
Audience
Who the bundle is for
- Manufacturers building a complete IVDR submission from the beginning
- Organisations converting a portfolio from Directive 98/79/EC, device after device
- Consultants running several IVDR projects in parallel
- Companies that already hold the MDR bundle and are extending to diagnostics
- Teams that would otherwise buy two kits and then need the third
Questions
Before you buy
Can I buy the kits separately later?
Yes, each is sold on its own. The bundle costs €178 less than the three together and adds six documents that are not available separately. If you are still deciding what you need, the IVDR guide explains what the Regulation asks for and in what order.
I already own the MDR bundle. Is this a duplicate?
Partly. The risk management process is common to both regulations, so four of the six risk templates will be recognisable. What is genuinely new is the Annex I IVDR GSPR checklist, the IVD hazard content, and the whole of the technical documentation and performance evaluation kits.
Are all 31 documents finished?
The three kits are complete. Two of the six additional documents — the labelling checklist and the regulatory strategy — are in preparation and are delivered to bundle customers as soon as they are released, at no further cost.
What is the licence?
One-time payment, perpetual licence for use within your organisation. Rebrand the templates, renumber them, merge them into your document control system.
Do I get updates?
Yes. Regulatory and guidance updates are provided free of charge to existing customers, for all four kits.
Can my company buy several licences?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
EU IVDR Complete Bundle
31 templates in Word and Excel: the Annex II technical file, the Annex XIII performance evaluation, the ISO 14971 risk management file, and six documents available nowhere else. Instant download, free updates, no expiry.
€999.00
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