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16Jul 2024
News, EU, IVD admin Comments: 0

EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers

On July 9, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) and took effect immediately. This new regulation aims to address the expected shortages of in vitro diagnostic medical devices (IVDs) in the EU due to the slower-than-expected transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR).  Following the removal of the sell-off provisions in Article 110.4, made official with Regulation (EU) 202...
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13Jul 2024
IVD Cubicdesignz Comments: 0

Labelling and IFU requirements of the New EU IVDR

Information for use (IFU) and labels must be provided with every In-Vitro diagnostic medical device, containing information to identify the device, its manufacturer and any relevant safety and performance information for the user or any other person.     Such information may be found on the device itself, in the packaging, or in the user instructions (IFU), and if the manufacturer has a website, it must be made available and maintained up to date on the website. Updates in Labelli...
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12Jul 2024
EU, IVD Cubicdesignz Comments: 0

MDCG Guidance on Article 110(3) of the IVDR

MDGC Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR aims to provide clarification on the concept of ‘significant changes in the design and intended purpose’. This article applies to manufacturers of devices that comply with Directive 98/79/EC and is placed on the market or put into operation after the transition period ends on May 26, 2022, irrespective of the involvement of notified body under the IVDD. It is important to note that IVDR...
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12Jul 2024
EU, EU MDR, General Information, IVD Cubicdesignz Comments: 0

Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

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05Feb 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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