como novedad incluye …
- Segunda Corrigenda de los Reglamentos de productos sanitarios
- Documentos adoptados por el MDCG
- MDCG 2019-6v2 Questions and answers: Requirements relating to notify bodies
- MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to the directives
- MDCG 2019-12 Designating authority’s final assessment form: Key information (EN)
- MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation
- MDCG 2019-14 Explanatory note on MDR codes
- MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG 2019-16 Guidance on cybersecurity for medical devices
- MDCG 2019-15 Guidance notes for manufacturers of class I medical devices
- Información sobre el desarrollo de la base de datos europea de productos sanitarios EUDAMED
- Vigilancia de Productos Sanitarios