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

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

Resources

MDR Links