+33 (0)6 47 17 67 07 contact@nexialist.fr
  • 
  •  Contact
  • Français
  • English
Nexialist - votre partenaire pour la conformité des dispositifs médicaux
  • The company
    • Discover Nexialist
    • Our team of experts
    • Recruitment area
  • Your needs
  • Our solutions
    • Phaos – NEW
    • PYXIS
    • nex’inform
  • News & Uptades
    • MDCG
    • Artificial Intelligence
    • Clinical evaluation
    • Corporate
    • Digital health
    • Electrical devices
    • Innovation
    • PMS / PMCF
    • Process / Production
    • Quality
    • Regulation
    • Risk management
    • Software
    • Technical documentation
    • Unique Device Identification System (UDI System)
    • GLOSSARY
Select Page

MDCG 2018-4 : Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs – October 2018

19 Nov 2020 | MDCG

Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 29(2) Annex VI Part B Documents mentioned   This guide provides...

MDCG 2018-3 Rev.1 : Guidance on UDI for systems and procedure packs – June 2018

19 Nov 2020 | MDCG

Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 22 Article 29(2) Annex VI Part C points 3.7 and 6.3.1 Documents...

MDCG 2018-2 : Future EU medical device nomenclature – Description of requirements – Mars 2018

19 Nov 2020 | MDCG

  Theme European MD nomenclature (EMDN) Target audience All actors Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23 Documents mentioned   The purpose of this guide is to clarify the criteria and...

MDCG 2018-1 Rev. 4 : Guidance on basic UDI-DI and changes to UDI-DI – March 2020

19 Nov 2020 | MDCG

  Theme Basic UDI and UDI-DI Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Chapter III Annex VI IVDR (EU) 2017/746 Chapter III Annex VI Documents mentioned UDIWG 2018-1 European Commission : Q/A about UDI  ...

MD and IVD Regulations and standards: where are we now?

13 Nov 2020 | All the News, Risk management

On 29 October 2020, the European Commission published a new version of the Draft standardisation request as regards medical devices (MD) in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices (IVD) in support of Regulation (EU) 2017/746. Does...
« Older Entries
Next Entries »

Search in the Website

All the topics

  • Clinical evaluation
  • Corporate
  • Digital health
  • Electrical devices
  • Innovation
  • MDCG
  • PMS / PMCF
  • Process / Production
  • Quality
  • Regulation
  • Risk management
  • Unique Device Identification System (UDI System)

#Tags

Animal origin Biocompatibility Borderline Classification Clinical trials Datas Homologation Labeling Matières premières Medical devices Mise sur le marché Placing on the market Qualification Retraitement Sterilization Usability

Archives

Contact us

Le Forum Bat B
515 Avenue de La Tramontane
13600 La Ciotat
FRANCE

+33 (0)4 42 01 60 29
Write us

Nexialist

Nexialist : Intelligence règlementaire et conformité des produits de santé

About us

Nexialist works with companies in the medical device sector, including in vitro diagnostic and advanced therapy devices. We provide assistance with any compliance, quality, and regulatory-related challenges as well as product development and commercialisation strategy.

Legal informations

  • Privacy policy
  • Legal notice
  • Sitemap

Nexialist’s universe

  • NEXIALIST
  • NEXINFORM

Follow us on…

© NEXIALIST - Réalisation : Nathalie Brunelli, Mirobolus 2019