­
List of EU Notified Bodies designated under the EU MDR and EU IVDR – Elexes
Elexes Medical Consulting

EU Notified Bodies designated under the EU MDR (2017/745)

Sl.No.Notified Body NameNotified Body LocationNotified Body Number
1BSI Assurance UK LtdUnited Kingdom0086
2BSI Group The Netherlands B.V.The Netherlands2797
3CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.Hungary2409
4DARE!! Services B.V.The Netherlands1912
5DEKRA Certification B.V.The Netherlands0344
6DEKRA Certification GmbHGermany0124
7DNV GL Presafe ASNorway2460
8GMEDFrance0459
9IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.Italy0051
10Intertek Medical Notified Body ABSweden2862
11MDC MEDICAL DEVICE CERTIFICATION GMBHGermany0483
12MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBHGermany0482
13National Standards Authority of Ireland (NSAI)Ireland0050
14TÜV Rheinland LGA Products GmbHGermany0197
15TÜV SÜD Product Service GmbH ZertifizierstellenGermany0123
16DQS Medizinprodukte GmbHGermany0297

EU Notified Bodies designated under the EU IVDR (2017/746)

Sl.No.Notified Body NameNotified Body LocationNotified Body Number
1BSI Assurance UK LtdUnited Kingdom0086
2BSI Group The Netherlands B.V.The Netherlands2797
3DEKRA Certification GmbHGermany0124
4TÜV SÜD Product Service GmbH ZertifizierstellenGermany0123

Leave a Reply




You may also like

Medical Devices

Clinical trials in South Africa – worldwide accepted data

Clinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial

Medical Devices

RUO – A Market Opportunity for IVD companies

Getting an IVD product to the market is a cumbersome task and takes several months to over a year to finally get everyth

Medical Devices

Official Number is now 15 – MDD to MDR + IVDD to IVDR Planning

Everyone knows that the advent of MDR was postponed, and the new regulation shall be in full force from May 26, 2021. As

Medical Devices

Who regulates your products?

The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your