NANDO db – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sun, 12 Jun 2022 18:14:11 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png NANDO db – Eisner Safety Consultants https://eisnersafety.com 32 32 MDR / IVDR Designation 2019 Stats https://eisnersafety.com/2019/12/31/mdr-ivdr-designation-2019-stats/?utm_source=rss&utm_medium=rss&utm_campaign=mdr-ivdr-designation-2019-stats Tue, 31 Dec 2019 22:59:04 +0000 https://www.eisnersafety.com/eisnersafetycom/?p=6446

EU Commission promised 20 Designations

12 Notified Bodies Designated to MDR (9) & IVDR (3*)

*All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective.

2 NB’s are likely to be “de-designated” (not sure of the proper term yet) end of Jan 2020 based on Brexit. That would be BSI Assurance UK Ltd.

The EU Commission has promised more NB’s to be designated in the 1st quarter of 2020. Let’s hope this will get us to at least 20 NB’s.

Two last-minute Christmas presents were BSI Group Netherlands IVDR and Medcert’s MDR designations on 24 & 25 Dec respectively.

Few products have been CE marked to the MDR that have gone through a NB review process. Typically the process is taking at least a year or more. Your quality system and product files need to be reviewed.

You are running out of time with the transition only about 5 months away.

Notified Bodies Designated to MDR & IVDR as of 31 Dec 2019

Not all NB’s have full coverage of the NANDO codes so check the NANDO database (MDR link) or check with your NB.

May you have a Happy, Safe, & Prosperous New Year and may your medical device be CE Marked under the MDR in the New Year.

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