MDR 2017/745 · Annex II/III · PMS/PSUR
EU MDR software that keeps technical documentation, PMS and vigilance records together.
V5 assembles it as one file that a Notified Body auditor can navigate in an hour.
Annex II + III as Live Documents
PMS Plan, PSUR and Trending
PMCF Plan + Evaluation Report
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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
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
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.
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.
What changes the day this goes live.
- Annex II/III is a living document, not a snapshot on a shared drive
- 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.
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.
What are the vigilance clocks?
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.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run EU MDR on one living technical file.
Free trial. Real Annex II, real UDI-DI, real vigilance clocks.