Understanding the Specific Evaluation Documentation Required for IVD Performance Under Article 56 of the IVDR
Specific IVD performance evaluation documentation required under Article 56 of the IVDR includes: Performance Evaluation Plan (PEP)…
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Planning for Performance Evaluation Under the IVDR
Even for those that have prepared a performance evaluation summary document for an IVD CE marked under the IVDD…
Shipping Devices and IVDs Directly to Consumers? | EU MDR Economic Operators
The EU MDR/IVDR establishes specific regulatory obligations for economic operators, including importers. The concept of “placing…
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…
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…
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