Knowledge · Notified bodies
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.