EU Regulatory Importer: Legal Liabilities & Considerations
Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an…
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Integrating Swiss MedDO and IvDO into your QMS
Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro…
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…
IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
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,…
Navigating the Current US FDA Medical Device Classification
For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to…
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…
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