New Product Liability Directive Proposal | Medical Devices/IVDs
More than 30 years since the Product Liability Directive (PLD) was established and after the Commission assessed its regulatory…
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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…
Swissdamed: Swiss Database on Medical Devices
Swissmedic has officially announced the launch of…
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…
Why You Need To Get MDR Certification In 2023
If your plan was to wait until 2023 to leisurely address compliance with the Medical Device Regulation (MDR 2017/745) and…
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...
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