What is A Notified Body?
Notified Body Definition
A notified body is an organization that has been designated by an EU member state to assess the conformity of medical devices against the relevant EU regulations (e.g., MDR 2017/745, IVDR 2017/746). Assessments involve review of manufacturer’s quality system and review of technical documentation that supports safety and performance claims of the device. A database of Notified Bodies for all relevant EU legislation is housed under NANDO (New Approach Notified and Designated Organizations).
Current lists of MDR- and IVDR-designated Notified Bodies.
Below is an updated list of all the Notified Bodies currently designated under EU MDR:
- UDEM Adriatic d.o.o. (Croatia)
- GMED (France)
- Eurofins Expert Services Oy (Finland)
- SGS Fimko Oy (Finland)
- DEKRA Certification GmbH (Germany)
- DQS Medizinprodukte GmbH (Germany)
- MDC Medical Device Certification GmbH (Germany)
- MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH (Germany)
- TÜV Rheinland LGA Products GmbH (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
- CE Certiso Orvos (Hungary)
- National Standards Authority of Ireland (NSAI) (Ireland)
- IMQ (Instituto Italiano del Marchio di Qualita) S.P.A. (Italy)
- Istituto Superiore di Sanità (Italy)
- BSI Group The Netherlands B.V. (The Netherlands)
- DARE!! Services B.V. (The Netherlands)
- DEKRA Certification B.V. (The Netherlands)
- DNV Product Assurance AS (Norway)
- 3EC International a.s. (Slovakia)
- Intertek Medical Notified Body AB (Sweden)
The following Notified Bodies are designated under EU IVDR:
- DEKRA Certification GmbH (Germany)
- TÜV Rheinland LGA Products GmbH (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
- BSI Group The Netherlands B.V. (The Netherlands)
Source: https://www.emergobyul.com
FAQs
Who are the notified bodies?
A notified body is an entity appointed by a member state of the European Union to assess the safety and effectiveness of products before they are placed on the market. Notified bodies must submit applications to become designated under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). A complete listing of the notified bodies that are officially designated is maintained on the NANDO (New Approach Notified and Designated Organizations) database.
What is the role of a notified body in CE marking?
A notified body reviews and assesses a manufacturer’s quality management system and technical documentation to determine whether the medical device conforms to EU regulations. If the documentation meets the necessary requirements, the notified body will issue a certificate allowing the manufacturer to place a CE mark on the medical device and market and sell the product.
The Cost
of
Mistakes
Delivering new products to market is challenging. And it is difficult to see the cost impact of one or more mistakes.
Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.