Kiwa Dare

Updated August 13, 2026

Kiwa Dare is a conformity assessment body based in the Netherlands, identified as notified body NB 1912. NANDO lists it as currently designated under the EU Medical Devices Regulation (MDR). Its detailed NANDO scope shows the device categories and conformity assessment activities covered by that designation.

2 Reviews

4.5 Good · 2 reviews

Read all reviews

Overall experience: 4.5

Well-organized / responsive: 4.0

Regulatory pragmatism: 4.0

Technical competence: 5.0

May 25, 2022

Review by company with 1-9 people

QMS audit done

Techdoc audit done

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence

Wait time before QMS audit: 0 Months
Wait time before Techdoc audit: 1 Month
Wait time before QMS certificate: 1 Month
Wait time before Techdoc certificate: 1 Month
Approx. cost (EUR): 25,000 €

I have no reference for medical regulatory pragmatic rating. Compared to space 9100 i would say this is not at all pragmatic.

Additional Comments (Duration/Cost): incl. ncrs

May 19, 2022

Review by company with 1-9 people

QMS audit done

Techdoc audit done

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence

Wait time before QMS audit: 4 Months
Wait time before Techdoc audit: 2 Months
Wait time before QMS certificate: 2 Months
Wait time before Techdoc certificate: 1 Month
Approx. cost (EUR): 23,000 €

Good communication, can call them with questions. Freelance auditor was good and had sufficient knowledge. Back and forth about significant/non-significant changes to certified product was good experience. They were quick to review and accept product changes.

Additional Comments (Duration/Cost): Application review (3000 euro); Year 1 audits (20000 euro); Surveillance audits (5000 euro); unannounced audits (7000 euro). Timelines and costs very clear up front.

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Key facts

About Kiwa Dare

Number: NB 1912
Country: NL
Current designation: MDR; View NANDO record; Checked August 13, 2026
Published standard fees: Published standard fees include €310 per audit hour and €400–€415 per hour for technical documentation assessment, depending on region.; MDR fee schedule; Checked August 13, 2026; Standard fees are not a quote. The final cost depends on the device and assessment scope.