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The new IVDR has introduced a risk-based classification system for in-vitro diagnostic medical devices. It determines the complexity of the conformity assessment for IVD-CE-marking. Find out how IVDs are classified according to IVDR.


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Classification of in-vitro diagnostic medical devices under the IVDR - Decomplix The new IVDR (Regulation (EU) 2017/746) has introduced a risk-based classification system for in-vitro diagnostic medical devices (IVDs), analogous to that of non-IVDs, that did not exist under the former EU Directive 98/79/EC (IVDD). IVD classification determines the level of complexity of the conf...

Medical devices and IVDs that were CE-marked under previous EU directives can remain on the market under certain conditions. These products are referred to as "legacy devices". Here is all you need to know about it.


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“Legacy” medical devices and IVDs under EU legislation - Decomplix If you are uncertain about the legacy qualification of your medical device or in-vitro diagnostic device (IVD), or you wish to know more about how legacy devices are regulated under the EU MDR or IVDR, read on.

The medical device risk classification has wide-ranging consequences for the regulatory requirements over the product’s entire lifecycle. 8 things you need to know about classification under the EU MDR.


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https://decomplix.com/newsletter/ for regular updates around regulation of medical devices.

Medical Device Risk Classification under MDR - 8 Things to Know Here are 8 things you need to know about medical device risk classification in the EU (MDR).

Are you unclear about the requirements for importing medical devices into Switzerland? Is there such a thing as a "virtual" Swiss importer? Here is all you need to know about it.


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Swiss Medical Device Importers - Regulatory Requirements - Decomplix Are you unclear about the requirements for importing medical devices into Switzerland? Here is all you need to know about it.

All medical device manufacturers and EU authorised representatives must have appointed a Person Responsible for Regulatory Compliance (PRRC). Not familiar with the PRRC role? Read on.

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Get regular updates on medical device CE marking:
https://decomplix.com/newsletter/

Person Responsible for Regulatory Compliance (PRRC) & MDR MDR and IVDR introduce the new role of the person responsible for regulatory compliance, the PRRC. Find out more about what this role means under MDR.

Choosing the US or EU as the first market for your medical device needs careful consideration of the regulatory implications. Read our latest article on: medical device regulatory strategy – US vs. EU


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Get regular updates around CE certification of medical devices: https://decomplix.com/newsletter/

Medical Device Regulatory Strategy for US & EU Markets - Decomplix Read our tips for preparing a regulatory strategy for medical devices in the United States (US) and the European Union (EU).