What PMS documents are required under EU MDR?

EU MDR requires a Post-Market Surveillance (PMS) Plan, annual Post-Market Surveillance Reports (PMSR) for Class I devices, and Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices. A PMCF Plan and PMCF Report are also required.

How often must a PSUR be updated?

For Class IIb and III devices, PSURs must be updated at least annually. For Class IIa devices, at least every 2 years. The PSUR must be reviewed by your notified body during surveillance audits.

Can the same writer prepare both the PMCF Plan and PMCF Report?

Yes. A writer familiar with your device and its clinical data is well-positioned to write both the PMCF Plan (specifying data collection activities) and the subsequent PMCF Report (summarizing findings).

Book PMS, PMCF Plan & PSUR Writing Support

Book PMS, PMCF Plan, and PSUR writing support for EU MDR compliance online. Compare vetted medical writing consultants with instant per-document pricing.

✓ 3 active providers available right now · EUR 1,328 – 1,640

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Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 1,440	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 1,640	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 1,328	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

reportType (Required)
pms_plan|pmcf_plan|pmcf_report|psur
deviceClass (Required)
I|IIa|IIb|III
deviceFamiliesCount (Required)
min 1
dataReadiness (Required)
low|medium|high
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Documents

PMS Plan · PMCF · PSUR / SSCP

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Output

Drafted + referenced document

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Turnaround

15–40 business days

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Pricing

Per document / per device family

How it works

1

Describe your device and current PMS status

Tell us your device class, CE/MDR certification status, and which PMS/PMCF/PSUR documents you need written or updated.
2

Compare medical writing consultants

View per-document fees from EU MDR-experienced writers who can author or update your post-market surveillance documentation.
3

Receive a notified-body-ready document

Your writer delivers a complete, referenced PMS document aligned to MDCG guidance and your device's clinical and safety data.

What post-market documents does EU MDR require?

EU MDR 2017/745 introduced substantially more extensive post-market documentation requirements than the previous Medical Devices Directive (MDD). The full suite of required post-market documents includes: (1) the Post-Market Surveillance (PMS) Plan — a proactive plan detailing how you will collect and analyze field data for your device; (2) the Post-Market Surveillance Report (PMSR) — an annual summary of post-market data for Class I devices; (3) the Periodic Safety Update Report (PSUR) — a more detailed regular report for Class IIa, IIb, and III devices; (4) the Post-Market Clinical Follow-up (PMCF) Plan — detailing how you will collect clinical data from the post-market phase; and (5) the PMCF Report — summarizing the findings of your PMCF activities.

PSUR update frequency and notified body review

For Class IIb and Class III devices, PSURs must be prepared at least annually. For Class IIa devices, the update frequency is at least every two years. PSURs are submitted to and reviewed by your notified body during surveillance audits — they are not sent to a competent authority (unlike the SSCP, which is publicly available). The PSUR must contain: a summary of post-market surveillance data collected; a benefit-risk assessment; conclusions about the continued safety and performance of the device; any changes made to the device or its documentation as a result of PMS data; and the conclusions of your clinical evaluation update. Notified bodies have been increasingly rigorous in their PSUR review, issuing major NCRs where PSURs contain only generic assessments without device-specific data.

PMCF: what it requires and common misconceptions

Post-Market Clinical Follow-up (PMCF) is a continued clinical investigation performed after CE marking to confirm the long-term safety and performance of the device. Under EU MDR, a PMCF Plan is required for all CE-marked devices unless a specific PMCF justification explains why PMCF is not applicable — and the bar for this justification is high. PMCF activities can include: registries, post-market clinical studies, systematic literature surveillance of equivalent devices, structured questionnaire studies, and analysis of clinical complaint data. A common misconception is that complaint handling data alone constitutes adequate PMCF — it does not. You need a separate, prospective PMCF methodology with pre-defined endpoints that are clinically meaningful.

What makes a good PMS Plan or PSUR?

A high-quality PMS Plan specifies, for each data source, what data is collected, at what frequency, by what method, and what the acceptance criteria are for detecting a safety signal. It is device-specific — not a generic template — and references the device's risk management file and clinical evaluation. A good PSUR interprets the data collected against these predefined criteria, provides a genuine benefit-risk conclusion (not just "no new safety signals"), proposes specific changes or actions where data warrants, and is written in language that a notified body clinical reviewer can directly evaluate. On Cruxi Bridge, you can commission PMS Plan writing, PSUR writing, or PMCF Plan writing individually or as a package from EU MDR-experienced medical writers.

Frequently asked questions

What PMS documents are required under EU MDR?: EU MDR requires a Post-Market Surveillance (PMS) Plan, annual Post-Market Surveillance Reports (PMSR) for Class I devices, and Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices. A PMCF Plan and PMCF Report are also required.
How often must a PSUR be updated?: For Class IIb and III devices, PSURs must be updated at least annually. For Class IIa devices, at least every 2 years. The PSUR must be reviewed by your notified body during surveillance audits.
Can the same writer prepare both the PMCF Plan and PMCF Report?: Yes. A writer familiar with your device and its clinical data is well-positioned to write both the PMCF Plan (specifying data collection activities) and the subsequent PMCF Report (summarizing findings).

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