Panoramica

I dispositivi medici e i dispositivi medico-diagnostici in vitro rivestono un ruolo fondamentale nel salvare vite, poiché forniscono soluzioni…

Direttive vigenti

Attualmente nell'UE si applicano le seguenti direttive sui dispositivi medici:1998: direttiva 98/79/CE del Parlamento europeo e del Consiglio…

Nuovi regolamenti

L'UE ha modificato le norme che disciplinano i dispositivi medici e i dispositivi medico-diagnostici in vitro per adeguarle agli sviluppi del settore negli ultimi vent'anni. I...

Ultimi aggiornamenti

News announcement | 25 maggio 2022

Public health: Stronger rules for placing medical tests on the market

News announcement | 25 maggio 2022

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

News announcement | 24 maggio 2022

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

News announcement | 20 maggio 2022

MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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Highlights

News announcement | 24 maggio 2022

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

News announcement | 26 maggio 2021

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices

General publications | 12 luglio 2020

Commission guidelines on Union-wide derogations for medical devices

General publications | 26 giugno 2020

List of COVID-19 essential Medical Devices (MDs and IVDs)

General publications | 24 giugno 2020

Guidance on regulatory requirements for medical face masks

Eventi

07mag2021

Riunioni dei partner

Webinar for Patients – Safe and performant Medical Devices for all

Dispositivi Medici - Settore

Panoramica

Direttive vigenti

Nuovi regolamenti

Ultimi aggiornamenti

Public health: Stronger rules for placing medical tests on the market

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Highlights

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices

Commission guidelines on Union-wide derogations for medical devices

List of COVID-19 essential Medical Devices (MDs and IVDs)

Guidance on regulatory requirements for medical face masks

Eventi

Documenti

Events

Publications