European Commission Proposes to Extend Deadlines for IVDs
The European Commission published a proposal to amend 2017/745 (MDR) and 2017/746 (IVDR) on January 23rd 2024…
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Swissdamed Database Launch Delayed to 2nd Half of 2024
Swissdamed, the Swiss registrations database, was originally due to go live in late 2023. As that date has now passed,…
The Impact of the MDR 2023/607 on Medical Device Regulations
The Medical Device Regulations (2017/745) (“MDR”) called out a Date of Application of 26 May 2021, for which all Class…
FDA Final Rule to Amend Medical Device Quality System Management Regulation
The FDA published the Quality System Management Final Rule on January 31st. This rule amends the current device good manufacturing…
New EU MDCG Guidance on Medical Device Vigilance Requirements
A large release of the…
MDR and IVDR Language Requirements Update
The European Commission, in collaboration with Member States, has introduced tables under the Medical Device Regulation (MDR) and…
MHRA’s Revised Medical Device Regulations Roadmap
On the 9th of January, the MHRA in the UK published an updated roadmap to regulation of medical devices in…
Swissmedic Provides Definition for In-House IVDs
Swissmedic has recently updated their FAQ that provides the definition for in-house IVDs, and examples of what is and…
Swissmedic’s Changes on IVD Notifications
Swissmedic, has recently issued a revised version of a guidance document that addresses In Vitro Diagnostic Devices. This updated guidance…
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