EU MDR software with Annex II/III, EUDAMED and PMS as one living technical file.
Regulation (EU) 2017/745 turned the CE-mark file into a living technical documentation stack: Annex II general documentation, Annex III post-market surveillance, UDI-DI/PI to EUDAMED, PMCF plans and evaluation reports, PSURs on the class-driven cadence, and vigilance/FSCA reporting inside strict clocks. V5 assembles it as one file that a Notified Body auditor can navigate in an hour.
You're shopping because the MDD transition drained the team and the file is a snapshot, not a living document.
Annex II technical documentation is a SharePoint archive nobody trusts as current
UDI-DI, UDI-PI and EUDAMED actor data drift from what's on the label
PSUR cadence (annual for Class IIb/III, biennial for IIa) slips because no one owns the clock
PMCF plan and evaluation report live outside PMS — reviewers can't see the loop close
Serious incident 15-day / 2-day / 10-day clocks are chased in email
Notified Body surveillance audits find gaps between labelling, DoC and EUDAMED
MDR, run as one living technical file.
Annex II + III as live documents
Device description, design/manufacturing info, GSPR checklist, risk management file (ISO 14971), clinical evaluation, benefit-risk, PMS system and PSUR — each section pinned to a current owner and revision, not a folder date.
UDI-DI / UDI-PI + EUDAMED sync
Basic UDI-DI, UDI-DI per configuration and UDI-PI at production tied to label output. Actor, device and certificate data prepared in EUDAMED-ready form; audit trail on every field.
PMS plan, PSUR and trending
Post-market surveillance plan per Article 84, PSUR on class-driven cadence (annual IIb/III, biennial IIa, on-request I), quantitative trending against baseline with signal thresholds.
PMCF plan + evaluation report
PMCF plan linked to residual clinical questions from the CER, evidence intake (registry, survey, literature), and PMCF evaluation report that feeds the next CER cycle — one loop, not two.
Vigilance: MIR, trend, FSCA
Serious incident triage with the 15-day / 2-day (death or serious public health threat) / 10-day (unanticipated public health threat) clocks, MIR generation, trend reporting, and Field Safety Corrective Action with FSN distribution log.
Notified Body audit pack
Every surveillance-audit ask — DoC, latest technical documentation, PMS/PSUR, complaints, CAPAs, EUDAMED submissions, supplier controls — resolves to a single evidence view with signed hashes.
What changes the day this goes live.
- Annex II/III is a living document, not a snapshot on a shared drive
- EUDAMED and label data reconcile to a single source of truth
- PSUR cadence runs on the class-correct clock with the correct denominators
- PMCF actually closes the loop back into the CER on the next cycle
- Vigilance clocks are visible and defensible before, during and after inspection
The frameworks an EU-market device manufacturer owns.
Regulation (EU) 2017/745 (MDR)
Annex I GSPR, Annex II technical documentation, Annex III PMS, Annex XIV clinical evaluation and PMCF, Articles 83–92 PMS/vigilance, Articles 27–31 UDI/EUDAMED — modelled end-to-end.
MDCG guidance in force
MDCG 2019-9 rev.1 (SSCP), MDCG 2020-7/-8 (PMCF plan and evaluation report), MDCG 2022-21 (PSUR), MDCG 2023-3 (vigilance) — built into the workflow, not a PDF someone re-reads once a year.
ISO 13485:2016 + ISO 14971:2019
The two horizontal standards the MDR technical file rests on. Same QMS engine, so risk file, design file and PMS file are always the same version.
EU MDR software, answered.
What is the PSUR cadence under MDR?
Article 86: Class IIb and III devices produce a PSUR at least annually; Class IIa produces one at least every two years; Class I is on-request (through the PMS report per Article 85). Cadence starts from the date placed on the market and refreshes across the certificate lifecycle.
How does V5 handle UDI-DI and EUDAMED?
V5 assigns Basic UDI-DI at product family, UDI-DI at configuration and UDI-PI at production, ties them to the label engine, and maintains actor/device/certificate data in EUDAMED-ready form. When EUDAMED modules go mandatory on their published dates, the submission surface is already assembled.
What are the vigilance clocks?
Article 87: 15 days for serious incidents by default; 2 days for a serious public-health threat; 10 days for death or unanticipated serious deterioration in health. Trend reporting for non-serious expected side effects that show statistically significant increase. V5 starts each clock on triage and shows it in the risk queue.
Do you handle legacy device transition and Article 120?
Yes. Amending Regulation (EU) 2023/607 extended certificate validity for compliant legacy devices (up to Dec 2027 for higher-risk, Dec 2028 for lower-risk). V5 tracks the transition conditions (no significant change, active MDR application, QMS in place, appropriate surveillance) and evidences them per device.
Run EU MDR on one living technical file.
Free trial. Real Annex II, real UDI-DI, real vigilance clocks.