Linee guida MEDDEV MDCG Dispositivi medici | Febbraio 2022

Update Rev. 27.0 Febbraio 2022 (01.02.2022) / List Guidance MEDDEVs/MDCG Febbr. 2022

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

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

New Rev. 27.0 February 2022:

In calce all'articolo Abbonati Marcatura CE:

- List of Guidance MEDDEVs e MDCG Rev. 27.0 | 01 February 2022 - PDF
_____

New Rev. 27.0 del 1° febbraio 2022:

- MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs). 
- MDCG 2022-1 Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices.
- MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation. 
- MDCG 2021-27 Questions and Answers on Articles 13 & 14 of 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 

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.
...

Certifico Srl - IT | Rev. 27.0 del 1° Febbraio 2022

segue

Info e download