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 |
Mobirise web page maker - See here