Here you find information about regulations and guidance documents that effects medical devices in EU
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All products in US are subject to promotion and advertisement controls. This is in addition to FDA requirements.
China is probably the most regulated market medical device market in the in the world. Here you find information about this
| MDR Guidance | Information |
|---|---|
| All MDCG Guidance | Here you find all Guidance document issues by MDCG |
| Classification | Start point for all medical devices |
| Software classification | If you have a software product you also need to read this one |
| Clinical evaluation | All devices need a clinical evaluation |
| MDR | The regulation itself |
| Significant changes | What is a significant change which might trip over your MDD product to MDR |
| MDCG Guidance | EU Guidance to the regulation |
| E users manual | EU Guidance on E users manual |
Looking for a 510(k) cleared product, then use this database
In this database you can find establishments and device listings
In this database you can find the classification of a specific product. You can search on several different parameters
To find the regulation number for your product you need to know type of panel the product falls into
FDA guide on how to classify your product. Not that straightforwards!
Here you find FDA produced learning videos covering many different aspects
Here you can find all guidance document with digital content or connection
Free text search on devices i order to find a product to compare with.
| MDR Guidance | Information |
|---|---|
| All MDCG Guidance | Here you find all Guidance document issues by MDCG |
| Classification | Start point for all IVD devices |
| Software classification | If you have a software product you also need to read this one |
| Clinical evaluation | All devices need clinical performance evaluation |
| IVDR | The regulation itself |
| MDC Guidance | EU Guidance to the regulation |
| EU Export control | Information |
|---|---|
| Export from EU | What applies when you export from EU to other countries |
| Overview export control | EU overview page of applicable requirements to consider |
| The EU export control regulation | The main export control rules, classification etc |
| EU Sanction list | This is the list for EU sanctions towards countries, persons etc |
| EU National requirements | National deviations and additional requirements |
| Research guidance | What applies for research projects from a export control view |
| EU Chemical export requirements | Specific guide about exporting chemicals for e.g. IVDs |
| International organizations | Information |
| Nuclear suppliers group | International group about radiating material export control requirements |
| Wassenaar group | The Wassenaar group discussing export control internationally |
| The Australia group | The Australia group discussing export control internationally |
| USA Export control | Information |
| BIS | BIS. All export control activities except embargo countries |
| The regulation | The regulation with all lists needed |
| OFAC | Office of Foreign Assets Control handles embargo countries |
| GDPR | Information |
|---|---|
| GDPR | Here you find the GDPR regulation in EU |
| MD | The machine directive, applicable to products with moving parts |
| LVD | Low voltage directive applies for products between 50 V AC/75V DC up to 1000/1500V |
| EMC | EMC requirements |
| Blue book | The basis for all regulations/Directives in EU. Describes the framework! |
| 765/2008 | Regulation on market surveillance, compliance of products and required responsible person |
| REACH | Regulations for chemicals applies to all products non CE marking |
| Rohs | Restrictions for certain substances |
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Email: info@lowendahl.eu
Phone: +46 (0) 722 31 33 55
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Clever Compliance
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