How IVD Manufacturers Can Prepare for IVDR Labeling Requirements
Given their scope, the labeling requirements established under the IVDR can be daunting for manufacturers, even for legacy device…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 370–378 of 396
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
Proposed Artificial Intelligence Liability Directive (AILD) & Medical Devices/IVDs
As noted in 2020, in the report on the European enterprise survey on the use of technologies…
Regulatory Compliance and the Meaning of “Placing on the Market”
The concepts of “making available” and “placing on the market” are fundamental to EU market access and it is…
Responsibilities of a SaMD Importer
As we’ve noted in a previous article, under the EU Medical Device Regulation (MDR) 2017/745 and…
Outline of the EU IVDR 2017/746: New Rules For Classification
One of the (many) significant changes brought about by the EU In Vitro Diagnostic Medical Device Regulation…
Swissmedic: How Medical Device Regulation Has Changed
Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which we will explore below. But…
The Difference Between a UK Importer and Responsible Person
For medical device and IVD manufacturers selling in the UK, much has changed in the last few years. First, the obvious: the UK is no longer part of the European Union.
Importer of Record- What is it?
If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an “Importer of Record.” Understandably, many...
Showing 370–378 of 396