EU MDR

EU MDR timeline calculator

CE marking (Notified Body route): this estimates a planning range for the Notified Body portion of MDR certification, then lets you add your own internal preparation time. It is not legal advice.

Calculator

Start with three inputs, then adjust advanced options if needed.

Common scenarios
Pick a preset to pre-fill the calculator.
Device class
Notified Body route (Class IIa, IIb, III).
Readiness
QMS running, evidence partial
Consolidates QMS, clinical evidence, and NB engagement into one slider.
Just startingSome docs draftedQMS running, evidence partialEvidence mostly completeSubmission ready
What this includes
  • Just starting: QMS not started, clinical investigation likely, NB not engaged.
  • Some docs drafted: QMS not started, some clinical evidence, NB shortlisting.
  • QMS running, evidence partial: QMS in progress, some clinical evidence, NB shortlisting.
  • Evidence mostly complete: QMS in progress, strong clinical evidence, NB engaged.
  • Submission ready: QMS certified, strong clinical evidence, NB engaged.
Your internal preparation time
Months you expect to spend finishing QMS and technical docs before submission.
6 mo
Advanced options
Novelty / complexity
Higher novelty tends to increase review depth.
Clinical evidence readiness
Investigation needs increase timeline risk.
QMS readiness
QMS maturity affects audit cycles.
Notified Body engagement
Earlier engagement reduces queue risk.
Special factor
May apply to devices incorporating a medicinal substance.
Estimated total
19 to 30 months
Timeline view
Internal prep
NB contracting
Assessment cycles
CAPA + decision
Notified Body timeline (planning range)13 to 24 mo
Application + written agreement1 to 3 mo
Conformity assessment + decision (remainder)10 to 23 mo
Reduce rework before extra Notified Body days.

Run a pre-submission gap analysis on your Technical File and get gaps plus cited evidence in minutes.

Run a gap analysis on your docs
What is driving the estimate
  • Readiness level: qms running, evidence partial affects audit cycles.
  • Internal prep adds 6 months.
Disclaimer: Planning tool only. MDR conformity assessment timelines depend on many factors including device classification, novelty, completeness of technical documentation, audit outcomes, and Notified Body capacity.
Methodology and sources

Summary of the baseline ranges and the sources behind them. Open to see the methodology details and links.

The baseline range for the Notified Body conformity assessment is taken from Team-NB, which states it typically takes 9 to 24 months and can be longer depending on novelty, complexity, risk class and Notified Body capacity.

We also separate out the initial NB application and contracting phase, where Team-NB's consensus document references data indicating it can take 1 to 3 months from application to conclusion of the written agreement for the majority of applications.

The calculator then nudges the estimate within that range based on factors that commonly affect cycle time (novelty, QMS readiness, clinical evidence readiness, and whether you have already started with a Notified Body). The underlying process steps (Stage 1 audit, Stage 2 audit, corrective actions, certification review) match a standard MDR conformity assessment flow.

For a subset of devices incorporating a medicinal substance, consultation timelines can apply. An example time window cited in MDR-related technical documentation assessment guidance is an opinion within 210 days after receipt of all necessary documentation, which can add material time depending on your pathway.

Team-NB typical duration range 9-24 months (and longer in some cases). Team-NB FAQ

Team-NB consensus document: application to written agreement often 1-3 months.

MDR conformity assessment flow (Stage 1, Stage 2, corrective actions, decision). SGS MDR process overview

Consultation example: opinion within 210 days after complete submission (where applicable). TUV SUD MDR/IVDR guidance

How AI Gap Analysis reduces MDR timeline risk

Notified Body timelines stretch when your evidence is hard to verify and triggers extra review cycles.

AI Gap Analysis reads your Technical File and QMS PDFs and gives you evidence-linked answers with citations and deep links to exact pages, plus gaps and recommendations so you can fix issues before submission.

  • Evidence with page links (show exactly where you meet a requirement)
  • A clear gap list (what's missing or weak)
  • Recommendations (what to fix next)

Reduce Notified Body rework before you submit

Upload your PDFs and get an evidence-ready gap report in minutes.

Run a gap analysis on your docs

FAQ

What timeline does this cover?

This estimates the Notified Body portion of MDR certification (application, audits, technical documentation assessment cycles, corrective actions, decision). You can add your internal prep as a separate input.

Why is the output a range, not a single date?

Real-world timelines depend on device novelty/complexity, the maturity of your QMS and clinical evidence, and Notified Body capacity. Team-NB explicitly describes this variability.

Can it take longer than 24 months?

Yes. Team-NB notes that timelines can be longer in some cases. The calculator flags plus scenarios when your inputs strongly suggest extended cycles.