Linee guida MEDDEV MDCG Dispositivi medici | Novembre 2019

Update Rev. 13.0 November 2019 (30.11.2019)

Allegate tutte le Linee guida ufficiali sui Dispositivi medici in accordo con la Direttiva 93/42/CEE e il nuovo Regolamento (UE) 2017/745

New Rev. 13.0 Novembre 2019:

- MDCG 2019-12 Designating authority's final assessment form: Key information (EN)

- MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Direttiva 93/42/CEE del Consiglio del 14 giugno 1993 concernente i dispositivi medici^(*)

^(*) Direttiva sostituita dal Regolamento (UE) 2017/745 | Si applica dal 20 Maggio 2020

New regulations

Guidance documents to assist stakeholders in implementing the Medical Devices Regulations.

1. MDCG documents

Current legislation

Guidance documents to assist stakeholders in implementing directives related to medical devices.
...

2. Guidance MEDDEVs

The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.

- The MEDDEVs are drafted by authorities charged with safeguarding public health. This is in accordance with the relevant annexes of the Directives;
- MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process;
- These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings;
- The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant Directive provisions.

Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.
...

....
segue


Info e download