Free download • PowerPoint • 82 slides
EU MDR 2017/745 Master Presentation
A complete slide deck on the EU Medical Device Regulation — classification, conformity assessment, GSPR, technical documentation, clinical evaluation, PMS, vigilance, UDI and EUDAMED. Built for trainers, RA/QA teams and anyone preparing for a notified body review.
- 16:9 widescreen — projects cleanly in any classroom or meeting room.
- Editable .pptx — add your logo, product examples and internal references.
- No sign-up — free for personal and internal training use.
What's inside
82 slides across 10 sections
Every topic is broken into short slides with article and annex references, tables and process flows, plus speaker notes on every slide.
| Slides | Section | Covers | Count |
|---|---|---|---|
| 3–10 | Foundations | Why MDR replaced the directives, MDD vs MDR, structure, chapter map, key dates, scope, Annex XVI. | 8 |
| 11–17 | Economic operators | Manufacturer, authorised representative, importer, distributor, PRRC and Article 16. | 7 |
| 18–24 | Classification | Classes I–III, implementing rules, all 22 Annex VIII rules and a classification method. | 7 |
| 25–31 | Conformity assessment | Routes by class, Annex IX–XI, notified bodies, CECP, DoC and CE marking. | 7 |
| 32–40 | GSPR & technical documentation | Annex I chapters, labelling, Annex II and III files, GSPR checklist, harmonised standards. | 9 |
| 41–45 | QMS & risk management | Article 10(9), ISO 13485 mapping, ISO 14971 lifecycle, supporting standards. | 5 |
| 46–54 | Clinical evaluation | CEP, CER, equivalence, clinical investigations, PMCF, SSCP, evidence hierarchy. | 9 |
| 55–62 | PMS & vigilance | PMS system, PMSR vs PSUR, 2/10/15-day reporting, FSCA, trends, market surveillance. | 8 |
| 63–69 | UDI, EUDAMED & labelling | UDI-DI/PI, Basic UDI-DI, deadlines, EUDAMED modules, registration, IFU and eIFU. | 7 |
| 70–82 | Special topics & roadmap | Software, implants, substances, special cases, transition, roadmap, NB findings, MDCG list, checklist. | 13 |
| 1–82 | Total | 82 |
Use it for
- Onboarding new QA, RA and production staff
- Preparing for notified body audits and technical file reviews
- MDD-to-MDR transition workshops
- Gap-analysis workshops with your team
- Supplier and contract-manufacturer training
Keep in mind
- It summarises Regulation (EU) 2017/745 — always check the official text and amendments.
- Add your own product, process and site examples before delivering it.
- Keep attendance records if you use it for evidence of training.
- Free to use internally; please don't resell or rebrand it as your own paid course.
- Questions or a branded version for your site? Email info@skillmed.in.
Turn the slides into a certificate
Reading the deck is a good start. Completing modules and passing the exam gets you a verifiable certificate you can share.
Something out of date in the deck? Email info@skillmed.in and we'll fix the download. More free material lives on the resources page.