MDR & IVDR: How many NBs we have?

The end of Brexit transition period (31/12/2020) has brought many important changes also for the medical device community.

Today, we highlight the removal of UK-based Notified bodies from the NANDO database as of beginning of 2021. This results in fewer Notified bodies being able to certify medical devices for the EU market, and we list below the NBs that can assist a manufacturer in obtaining the CE Certificate in accordance with EU MDR (17 in total) &  IVDR (4 in total).

MDR NB

 2265 3EC International a.s. Slovakia
 2797 BSI Group The Netherlands B.V. Netherlands
 2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
 1912 DARE!! Services B.V. Netherlands
 0344 DEKRA Certification B.V. Netherlands
 0124 DEKRA Certification GmbH Germany
 2460 DNV GL Presafe AS Norway
 0297 DQS Medizinprodukte GmbH Germany
 0459 GMED France
 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
 2862 Intertek Medical Notified Body AB Sweden
 0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany
 0050 National Standards Authority of Ireland (NSAI) Ireland
 0197 TÜV Rheinland LGA Products GmbH Germany
 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
 2696 UDEM Adriatic d.o.o. Croatia

IVDR NB

 2797 BSI Group The Netherlands B.V.  Netherlands
 0124 DEKRA Certification GmbH Germany
 0197 TÜV Rheinland LGA Products GmbH Germany
 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
Source: European Commission.(2020).NANDO.Retrieved on 04/01/2021 from https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main

For the specific scope of each Notified body, please click on the relevant link above.


Guidance on the new compliance process for the market of Great Britain  & Northern Ireland can be found in our Library of Documents: UK & Switzerland. Do not forget that an appointment of UK Responsible Person and registration of devices to the MHRA is new mandatory requirement!

We advise to keep track of the UK website regularly to make sure you are aware of the specificity of the new regime.


MDlaw team would like to wish you a Happy, Healthy and Prosperous 2021!

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