2024 News

Market access

Scopri come accedere ai mercati >

2024 - Notizie su dispositivi medici e aggiornamenti di settore

Ultime notizie

(EU) 2023/607 – 26 May 2024 deadline approaching >

Manufacturers to put in place an MDR compliant QMS and formally apply to a Notified Body under MDR On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect

Impact of (EU) 2023/607 on legacy devices and update on BSI implementation >

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect.

EU Commission proposal as regards transitional provisions for certain IVDs >

On 23 January 2024, the European Commission released a proposal regarding the transitional provisions for certain legacy in vitro diagnostic medical devices by providing manufacturers and notified bodies with additional time, under certain conditions, to complete applications and necessary conformity assessment procedures.

Medical Device services

Argomenti più richiesti

Training dedicato

Market access

2024 - Notizie su dispositivi medici e aggiornamenti di settore