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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...

Are you part of the medical device industry? Are you curious about whether you need a quality management system certification according to the ISO 13485 standard? Read our updated blog article.


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Understanding ISO 13485 - Certification of a Quality Management System Read how the ISO 13485 standard is meant to help medical device companies (primarily medical device manufacturers) set up a QMS.

Medical device and IVD Vigilance in EU and Switzerland. Read all about the requirements relative to the reporting of device-related issues to competent authorities in our new blog article.


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Medical device and IVD Vigilance in EU and Switzerland - Decomplix If you place medical devices and IVDs on the market in the EU and/or Switzerland, you must understand the requirements relative to the reporting of device-related issues to competent authorities. The terminology, reporting criteria, and timelines in the EU MDR/IVDR have evolved from the former Direc...

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.

Medical device “labelling” language requirements under EU MDR and IVDR? A challenge with 20 languages to consider. Here's all you need to know about it.


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Medical device “labelling” language requirements under the EU MDR and IVDR - Decomplix In the following blog post, you will get practical answers on how the languages are regulated in the MDR.

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).

All medical device manufacturers must establish a Post-market Surveillance system in compliance with the EU MDR or IVDR, even for legacy devices. Here is all you need to know about it.


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Post-Market Surveillance - 10 Questions about PMS & MDR Post-market surveillance (PMS) is an important part of the regulatory framework for medical devices in Europe. Read about the changes introduced by 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.

Have you heard about the Swiss authorised representatives for medical device manufacturers? You can find all you need to know in the latest update to our blog article.


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Swiss Authorized Representatives for Medical Device Manufacturers - Decomplix Have you heard about Swiss Authorized Representatives for medical device manufacturers yet? Here is all you need to know about it.

When is a change to your medical device "significant" and what are the consequences of "significant changes"? Find answers to these questions in our related article.


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

Medical device “significant changes” under the EU MDR & IVDR - Decomplix The transitional provisions in EU MDR and IVDR allow devices that are still CE-marked under the former Directives to remain as “legacy devices” under certain conditions, including that no “significant changes” be brought to their design or intended purpose.If you manufacture or place on the ...