GrowthImports by Emre Aykac https://padlet.com/growthimportseu/Bookmarks Made with a lightning strike of genius en-us 2022-05-21 05:11:05 UTC 2022-08-23 13:53:31 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/1709285817/c38662e2850efd55bf5da1819a77939c/Logo_Growth_Imports___Copy.png MDR Impact on Importers & Distributors | GrowthImports growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2193711473 If you are a non-EU manufacturer of medical devices or In-Vitro Diagnostic devices you need to comply with the Medical Device Regulation (MDR). The Regulation MDR Distributor and manufacturers have to assign an importer that will have to meet the requirements and will be liable and responsible for placing products on the EU market. 

An Importer has different responsibilities from the other Economic Operators such as the Authorized Representative and Distributors. With GrowthImports you will comply with Article 13 and have an independent partner for your importing needs across Europe and the United Kingdom.

]]> 2022-05-21 05:15:55 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2193711473 EU MDR / IVDR Requirements 6 Medical Device Repackaging and Relabeling growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2203425092 These conditions are reviewed on a case-to-case basis and are only applicable to EU importer and distributors.

The current MDCG guideline document clarifies the standards outlined in the new regulations. It is particularly concerned with the actions that medical device importers and distributors can carry out, which will not be considered equipment modifications.]]> 2022-05-29 12:14:05 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2203425092 The Economic Operators and CE Mark on Medical Devices growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2204300456 If you’re a medical device manufacturer, supplier, or importer but aren’t knowledgeable about the European Union Medical Devices Logistics (EU-MDL) and In Vitro Diagnostic Regulation (IVDR), it may be high time you did, as their implementation brings about significant changes to the way products get certified, which applies to all economic operators (EOs), spanning device manufacturers, suppliers, and importers that operate throughout Europe.]]> 2022-05-30 07:29:58 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2204300456 MDR and Economic Operators for Medical Devices growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2229445977 If you’re a medical device manufacturer, supplier, or importer but aren’t knowledgeable about the European Union Medical Device Regulation (EU-MDR) and In Vitro Diagnostic Regulation (IVDR), it may be high time you did, as their implementation brings about significant changes to the way products get certified, which applies to all economic operators (EOs), spanning device manufacturers, suppliers, and importers that operate throughout Europe.]]> 2022-06-24 03:36:27 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2229445977 Explaining the Role of Importer under EU MDR growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2229569633 Each economic operator will have replaced and additional responsibilities and liabilities. This article will explain the potential risks and complications of designating your distributor as your importer and the benefits of having one independent EU importer.]]> 2022-06-24 06:39:21 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2229569633 Risks and Market Complications of Designating Distributors as Your EU MDR-IVDR Importer growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2240133833 Under the old medical device importer (MDD 93/42/EEC), the requirement for a distributor is not mentioned, while the word importer appears three times. The new MDR (2017/745) implemented per May 26th 2021, revisits the entire supply chain and economic operators, namely: the manufacturer, authorized representative, importers, and distributors. Each economic operator will have replaced and additional responsibilities and liabilities. This article will explain the potential risks and complications of designating your distributor as your importer and the benefits of having one independent EU wide importer.]]> 2022-07-09 11:00:31 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2240133833 Guidelines Of Importing Medical Devices Into The European Union growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2244092900 The European medical device (MD) market is estimated to be worth around €140 billion. It is the second biggest MD market in the world, covering 27.6% of the world market, behind only the United States. This should be encouraging to medical device companies to consider exporting their products to the European Union (EU).
Medical devices logistics are divided into four classifications (Class I, Class IIa, Class IIb, and Class III) based on risk and intended use—the higher the risk, the higher the Class.
We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.

Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards. With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
]]> 2022-07-15 11:27:13 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2244092900 Exporting Medical Devices to Europe and Emerging Markets growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2268606781 The first step to export medical devices to Europe is to comply with regulatory requirements. Compliance is determined through the CE mark. It indicates that the manufacturer complied with European standards of safety, health, and environmental protection.


]]> 2022-08-23 10:20:30 UTC https://padlet.com/growthimportseu/Bookmarks/wish/2268606781 The EU MDR: Medical Device Advertising And Promotion growthimportseu https://padlet.com/growthimportseu/Bookmarks/wish/2268790010 The MDR distributor expanded this to include “as specified by the manufacturer in the clinical evaluation.” This means that if a marketing team makes a claim about a medical device, it should be backed by clinical data. Advertising should always center on the medical device’s intended purpose.

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