# Notified bodies: selection and conformity assessment | INOPREX

> Notified bodies examine and certify medical devices of higher classes in the EU MDR conformity assessment: selection, procedures, MDR certificates and audit process.

Quelle: https://inoporex.de/en/wissen/benannte-stellen/

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## Notified bodies: selection and conformity assessment

Whoever certifies medical devices from class Is/Im/Ir upwards needs a notified body.

Notified bodies are organisations designated and accredited by EU member states that examine and certify medical devices from class Is/Im/Ir upwards in the EU MDR conformity assessment. They audit the QM system and technical documentation and issue MDR certificates — the basis for CE marking of higher classes.

## Process of a certification procedure

- Inquiry with product information and classification
- Quotation and contract (scope per class and module)
- On-site QM audit (ISO 13485)
- Review of the technical documentation (class III: design dossier)
- Certificate decision, issuance with limited validity (max. 5 years)
- Annual surveillance audits and re-certification

## Selection criteria

- Accreditation for the product category and class (Nando database)
- Experience with your dosage form
- Capacity and processing time
- Costs and audit practice

## Frequently asked questions

**Does every medical device need a notified body?**

No — class I without a special route manages without one. All other classes need one.

## Applied to your project

We apply these rules directly to your project — from classification to market access. First assessment within two working days.

Stand: 2026-10-22 · Fachlich verantwortlich: INOPREX Scientific Direction