Notified Bodies
A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market.
These bodies are entitled to carry out tasks related to conformity assessment procedures set out in the applicable legislation when the intervention of a third party is required.
The Commission publishes a list of such notified bodies in the NANDO information system.
Since November 2017, conformity assessment bodies may apply for designation as notified bodies under Regulations (EU) 2017/745 and 2017/746.
- Guidance documents and forms are available here
- Designation process and scheduling of joint assessments: frequently asked questions via this explanatory note
- Information on the applications for designation as a notified body via this short overview
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746.
Noutăţi
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Data publicării18 ianuarie 2021Tema: Medical Devices - Sector, Medical Devices - New regulations, Medical Devices - Topics of Interest
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Data publicării11 ianuarie 2021Tema: Medical Devices - Sector, Medical Devices - New regulations, Medical Devices - Topics of Interest
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Data publicării11 decembrie 2020Tema: Medical Devices - Topics of Interest
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