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Decomplix

Simplify market access for medical devices. We provide expertise in CE certification and CH-REP.

12/08/2024

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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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...

07/06/2024

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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Read how the ISO 13485 standard is meant to help medical device companies (primarily medical device manufacturers) set up a QMS.

06/05/2024

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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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...

17/04/2024

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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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.

21/03/2024

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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In the following blog post, you will get practical answers on how the languages are regulated in the MDR.

14/02/2024

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.

Here are 8 things you need to know about medical device risk classification in the EU (MDR).

25/01/2024

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 (PMS) is an important part of the regulatory framework for medical devices in Europe. Read about the changes introduced by MDR.

12/12/2023

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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Are you unclear about the requirements for importing medical devices into Switzerland? Here is all you need to know about it.

20/11/2023

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

21/10/2023

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/

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 ...

12/09/2023

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/

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.

15/08/2023

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/

Read our tips for preparing a regulatory strategy for medical devices in the United States (US) and the European Union (EU).

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