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EUROPA - European Commission - Growth - Regulatory …
- https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
- Warning: As from 26 May 2021, the notified bodies designated under Directive 93/42/EEC as listed here are no longer able to issue new certificates under that Directive, but only allowed to carry out surveillance activities for certificates validly issued under that …
List of Notified Bodies under MDR on Medical Devices - AKRN
- https://akrnconsulting.com/list-of-notified-bodies-mdr/
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : …
- http://emisoft.co.uk/standards/europe/93-42-md/nb.pdf
- LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices Page 3 Name and address of the notified bodies Identification number Responsible for the …
Complete list of notified bodies for EU 93/42/EEC medical …
- http://www.ce-marking.org/NotifiedBodies/9342-MDD-Notified-Bodies.html
- Complete list of notified bodies for EU 93/42/EEC medical devices directive. Click to view the LATEST lists of Notified Bodies!
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …
MEDDEV Guidance List - Download - Medical Device Regulation
- https://www.medical-device-regulation.eu/meddev-guidance-list-download/
- MEDDEV 2.13 rev. 1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) As regards the …
European Commission
- https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900
- European Commission
MDCG 2023-3 Questions and Answers on vigilance terms …
- https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf
- Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC concerning medical devices (MDD) and Directive …
Notice to manufacturers and notified bodies- Nasal …
- https://www.aemps.gob.es/informa/notasInformativas/productosSanitarios/2023/Notice-to-manufacturers-and-notified-bodies.pdf
- European market in conformity with Directive 93/42/EEC, shall also have a clinical evaluation based on “sufficient clinical data”, as described in the MDCG 2020-6 guidance …
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