Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)

Name: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: applications,assessment,conformity-assessment,conformity-assessment-bodies,designation,diagnostics,forms,guidances,in-vitro-diagnostic-devices,in-vitro-diagnostics,in-vitro-diagnostics-regulation,ivd,ivd-devices,ivdr,mdcg,notified-bodies,regulations

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Notified Bodies

Published

July 1, 2021

Last updated

July 1, 2021

Description

Application form for conformity assessment bodies seeking designation as notified bodies under the IVDR.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

Suggest an improvement to this page

1 Main file

MDCG 2021-16

Updated on September 6, 2023

docx

URL: https://health.ec.europa.eu/document/download/2b39d49f-4158-4470-b051-268cea9f21e1_en?filename=mdcg_2021-16_en.docx
Permalink: https://data.openrid.co/en/datasets/r/2c238a99-0146-4d61-a7d4-8968444295af
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: September 6, 2023
Modified on: September 6, 2023