| 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 |
| Significant changes | What is a significant change which might trip over your MDD product to MDR |
| Significant changes | What is a significant change which might trip over your MDD product to MDR |
| 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 |
| 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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Sweden
Email: info@lowendahl.eu
Phone: +46 (0) 722 31 33 55
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Clever Compliance
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