New MDCG Device Specific Vigilance Guidance Documents Published
The Medical Device Coordination Group (MDCG) published several updated Device Specific Vigilance Guidance (DSVG) documents on January 30.
More on European Proposal to Delay Compliance for Legacy IVDs
The EC proposed extending the transitional provisions for certain IVD devices, following adoption of Regulation (EU) 2023/607, announced January 23.
EC Proposes Making Parts of EUDAMED Mandatory
The EC proposal to delay the compliance of IVDs also proposes a gradual roll-out of the European database on medical devices, EUDAMED. The EC proposes that certain modules of EUDAMED would become mandatory before completing all six modules.
EU Update: Deadline nears for medical device Regulation 2023/607
We briefly share again the requirements for Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR). Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by May 26, 2024, a quality management system and an agreement with said notified body by September 26, 2024.
EU Update: May 26 Deadline Approaches for Medical Device Regulation 2023/607 System and Procedure Packs
Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met.
UK Update: Increased UK-Approved Body Capacity
The UK’s MHRA updated its medical device legislation, which has greatly increased the UK’s current capacity to certify medical devices.
MDCG Updates Joint Implementation Plan for European IVDR
IVD manufacturers doing business in Europe will want to review regulators’ current list of priorities to maintain market access.
Regulation EU 2023/607 Frequently Found Issues
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about Regulation EU 2023/607.
EU Update: Overview of European Language Requirements for Medical Devices
The European Commission recently published two tables on its website to help manufacturers understand national language requirements under the MDR and IVDR.
EU Update: New Data Dashboard on Medical Device Availability
The EC has rolled out a new data dashboard to provide more transparency in medical device availability across European Union member states.