Regulatory cost calculator
Run the numbers on your route to market.
Enter your own price, volume, and margin. See what each way of reaching a submission-ready file costs, and what the difference in launch timing is worth to you.
- How many months of sales earn back what Venitara costs you
- What you spend with a consultancy, with Venitara, and doing it in-house
- What a difference in launch timing is worth, using your own margin
Enter your numbers
Every figure starts as an example. Replace each one with your own and the results update as you type. The calculation runs in your browser, and Venitara does not store what you enter. Your figures also appear in the address of this page, and the notes under the results explain what that means.
What each route costs, and the timelines behind it
These figures use your inputs and the published prices. The months are example assumptions that you can change, and Notified Body and regulator fees are not included in any of them.
The cost and time comparison appears here once the calculator has loaded. It needs JavaScript to run, and the published prices are on the pricing page.
Benchmarks to sense-check your timelines
These benchmarks run from a signed contract to an issued certificate, so they include Notified Body time. The timelines in this calculator end earlier, at a submission-ready file. Use the benchmarks as context when you set your own assumptions.
- Time to a new MDR certificate
- Among notified bodies that have issued quality management system (QMS) certificates, 62 per cent report 13 to 18 months from signed agreement to certificate, and 30 per cent report 6 to 12 months. For QMS plus product certificates, 51 per cent report 13 to 18 months, and 31 per cent report 19 to 24 months.
- Source: European Commission, 20th notified body survey, data status 28 February 2026, document dated 2 July 2026, slide 30.
- Where that time goes
- On average, notified bodies estimate that 56 per cent of the time to a certificate is spent with the manufacturer revising documents, and 44 per cent with the notified body checking them.
- Source: European Commission, 16th notified body survey, data status 30 June 2025, document dated 25 March 2026, slide 31. Estimates from 46 notified bodies.
- How complete submissions are
- In February 2026, 14 of the 52 notified bodies designated under the MDR said that more than half of the submissions they receive are complete without further information being requested.
- Source: European Commission, 20th notified body survey, data status 28 February 2026, slide 29.
- The notified bodies' own view
- Team-NB, the European association of notified bodies, reports that 65 per cent of submitted MDR files are missing half of the needed information.
- Source: Team-NB Medical Device Survey 2025, data from 41 members, and its press release of 18 May 2026.
Figures read from the published documents on 19 October 2026. The European Commission publishes the latest survey on its notified bodies page.
How these figures are worked out
- Contribution is units per year, times price per unit, times your contribution margin. The monthly figure is one twelfth of that.
- Your staff cost is the full-time equivalents on the file, times the annual cost of one, times the months the work takes, divided by twelve.
- Total cost is the external price plus your staff cost. A consultancy shows a range because its published price is a range.
- Reaching a submission-ready file earlier is assumed to bring your launch forward by the same number of months, and reaching it later is assumed to delay it by the same number. The value of launch timing is those months, times your monthly contribution. It is a gain where Venitara is earlier and a loss where it is later.
- Total advantage is the difference in total cost plus the value of launch timing.
- Payback is the total cost of Venitara divided by your monthly contribution, counted in months of sales after launch. It assumes your steady-state volume from the first month after launch.
About these figures
This calculator gives an illustrative estimate. It uses the numbers you enter and the prices Venitara publishes on its pricing page. It is not a quote, a forecast, or a guarantee of approval or of a launch date.
Timelines and staffing are example assumptions for you to set. Venitara guarantees no timeline, so no month count in this calculator is a Venitara forecast or commitment.
Notified Body fees, regulator fees, external testing, and clinical investigations are not included in any scenario.
Venitara attests submission readiness. It does not certify conformity, which only a Notified Body can do, and no result here predicts or guarantees that a Notified Body will approve your file.
The calculation runs in your browser and Venitara does not store your inputs. They are written into the address of this page, so a link you copy or share carries your figures. When you reload the page or open such a link, Venitara's hosting provider may log the request for that address, as it does for any page. The privacy notice says how long it keeps those logs.
Find out where you stand first.
The MedTech Compass takes about ten minutes and gives you an indicative view of how your device is likely to be regulated. Talk to a regulatory expert when you want a person to look at your route.
Free · AI-generated, not validated · about 10 minutes