Notified Bodies

MedTech Europe calls for technical documentation sampling of In Vitro diagnostics to become more risk-based

Sampling under IVDR: MedTech Europe proposal for a more risk-based approach

Sampling under In Vitro Diagnostics Regulation: MedTech Europe proposal for a more risk-based approach

EPSCO Council meeting on 14 June 2022

Milestone reached: EUDAMED UDI & Devices registration and Notified Bodies & Certificates modules launched for voluntary use

20th Notified Body designated under MDR: Eurofins Expert Services Oy – Finland

New Notified Body designated under MDR in Finland

Virtual/Remote MDR and IVDR Audits – Temporarily allowed under strict conditions

Notified Bodies developments

Industry reinstates its call for solutions to ensure a workable transition to the new regulatory frameworks for medical devices and in vitro diagnostics

The need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19

Notified Bodies: 2 additional notifications under MDR

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