EU MDR

Factsheets & FAQs

EU MDR

Factsheets & FAQs

Here, you will find a comprehensive collection of informative and practical resources related to the new regulation. This content provides clear and concise answers to some of the most common questions and concerns regarding EU MDR compliance.

Whether you're a healthcare provider or simply looking to learn more about the new regulation, our resources will provide you with valuable insights and guidance. So, take a look around and let us help you navigate the world of EU MDR!

Here, you will find a comprehensive collection of informative and practical resources related to the new regulation. This content provides clear and concise answers to some of the most common questions and concerns regarding EU MDR compliance.

Whether you're a healthcare provider or simply looking to learn more about the new regulation, our resources will provide you with valuable insights and guidance. So, take a look around and let us help you navigate the world of EU MDR!

You and EU MDR

What is EU MDR and what does it mean for you?

Labelling

What is changing and why?

Unique Device Identification (UDI)

How will UDI enhance traceability?

Instructions for Use [IFU] and Electronic Instructions for Use [eIFU]

What are the new EU MDR requirements for device instructions?

Implant Cards

Why do we need them and who is responsible for completing them?

EUDAMED

What is EUDAMED and what information will be available on the EU database?

Summary of Safety and Clinical Performance [SSCP]

What is this new EU MDR requirement?

Reprocessing of Single Use Devices

How will this be done under EU MDR?

Restrictive Substances

How will EU MDR impact how we manage the identification of restricted substances?

EU MDR FAQs

Are you curious to know more about EU MDR? Here are some questions, answered…