Can I switch Notified Bodies?

Yes, but the receiving Notified Body must conduct a full or targeted transfer assessment per MDCG 2022-11. Continuity is not automatic and the certificate transfer must be recorded.

What happens when a Notified Body withdraws designation?

MDCG 2022-8 gives manufacturers a defined period (typically 9-12 months) to find a new Notified Body. Devices remain lawfully on the market during transfer if conditions are met.

Is a UK Approved Body the same?

No. After Brexit, UK Approved Bodies assess conformity for the UKCA mark under the UK MDR 2002. They are distinct from EU Notified Bodies, though many organizations hold both designations.

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RegulatoryRegulated Pathways Global MarketsNB

Notified Body

EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

A Notified Body is an organization designated by an EU Member State competent authority (and listed in NANDO) to carry out conformity assessment tasks under Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR) before a device is placed on the EU market. Designation itself is governed by Implementing Regulation (EU) 2017/2185 and the joint assessment process.

What the regulation says

Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), Notified Bodies are conformity assessment bodies designated and monitored by national authorities to ensure that MedTech products meet the necessary safety and performance requirements before market placement. Their responsibilities include auditing manufacturers' quality management systems, assessing technical documentation, and issuing CE certificates, as detailed in MDR Annex VII and IVDR Annex VII.

What this means in practice

Under MDR/IVDR, Notified Body involvement is required for all devices above Class I (non-sterile, non-measuring, non-reusable surgical) and above IVD Class A non-sterile. As of 2026 there are approximately 50 MDR-designated and 15 IVDR-designated Notified Bodies, versus 80+ under the prior directives, which has driven multi-year queue times. The Commission and MDCG have issued repeated guidance (MDCG 2022-4, MDCG 2022-14, MDCG 2023-3) to increase capacity. Notified Bodies audit the quality management system, review technical documentation, issue CE certificates (valid up to 5 years), and conduct annual surveillance audits including unannounced audits per Implementing Regulation (EU) 2013/920.

Examples

BSI (UK/NL), TUV SUD (DE), TUV Rheinland (DE), DEKRA (DE), DNV (NO), IMQ (IT) are among the most active MDR Notified Bodies.
A Class IIb implantable receives Annex IX Chapter II technical documentation assessment on a representative device from each generic device group.
Class III and implantables trigger scrutiny procedure (Article 54) and expert panel consultation for certain novel devices.

Common pitfalls

•Submitting incomplete technical documentation. Notified Bodies charge for each round of review and clock the review time against contractual SLAs.
•Assuming a legacy MDD/IVDD Notified Body will automatically be designated for MDR/IVDR. Designation is per-code and per-regulation.
•Not planning for unannounced audits at critical suppliers. Article 44 of MDR requires the manufacturer to ensure the Notified Body has access.
•Confusing Notified Body with Competent Authority. Notified Bodies do conformity assessment; Competent Authorities do market surveillance and vigilance oversight.

Frequently asked questions

Match your device MDA/MDN/MDS or IVR/IVS/IVT codes to the Notified Body's scope in NANDO. Factor in queue length, language, cost, and prior sector experience (active implantables, IVDs, software) - these vary widely.

Cross-references

Used by

Things that build on this term.

EU Medical Device Regulation(MDR)

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

CE Mark

Mandatory European conformity mark for medical devices placed on the EU market.

Regulatory

EUDAMED

European Database on Medical Devices.

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

Regulatory

EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

EU MDR Essentials

· From this learning path

Post-Market

Field Safety Corrective Action(FSCA)

Action taken to reduce a risk of serious deterioration in health associated with a device.

Post-Market

Medical Device Vigilance

Reporting and management of serious incidents and field safety corrective actions.

Regulatory

Unique Device Identification(UDI)

System for adequate identification of medical devices through distribution and use.

Post-Market

Periodic Safety Update Report(PSUR)

Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

IVDR Essentials

· From this learning path

Regulatory

General Safety and Performance Requirements(GSPRs)

Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.

Adjacent lesson

Regulatory

IVDR Risk Classes A–D

EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).

Clinical & Trials

Clinical Evaluation Plan(CEP)

EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).

Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

Primary references

3 sources

Link health: 1 verified 2 unchecked· last checked 2026-06-20

European Commission·1MDCG·1EUR-Lex·1

Inline markers like [1] jump to the matching reference above.

On this term

Category: Regulatory
Acronym: NB
Sources: 3
Updated: 5/5/2026

Compare with another term

Learn in 60 seconds

EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

·Under MDR/IVDR, Notified Body involvement is required for all devices above Class I (non-sterile, non-measuring, non-reusable surgical) and above IVD Class A non-sterile.
·As of 2026 there are approximately 50 MDR-designated and 15 IVDR-designated Notified Bodies, versus 80+ under the prior directives, which has driven multi-year queue times.
·The Commission and MDCG have issued repeated guidance (MDCG 2022-4, MDCG 2022-14, MDCG 2023-3) to increase capacity.

Remember this

Watch out: Submitting incomplete technical documentation. Notified Bodies charge for each round of review and clock the review time against contractual SLAs.

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