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Home | Medical Device Regulation (MDR) | The new EU Medical Device Regulation enters into force
May 24, 2017

MDR Compliance The new EU Medical Device Regulation enters into force

After years of tough negotiations, the new European Medical Device Regulation (MDR) is officially taking effect on May 25th, 2017. Medical device manufacturers can expect considerable additional burdens for the MDR Compliance.

 

MDR Compliance — here are the most important changes at a glance

Scrutiny process

For high-risk medical devices, notified bodies are obligated to consult an EU expert committee, whose task is to intervene in cases of suspicion of deficits.

 

Clinical assessment and postmarketing surveillance

The MDR Compliance tightens the requirements and calls for systematic market monitoring with shorter reporting obligations and clinical follow-up. Clinical data must be collected, documented, and evaluated continuously, even after market introduction.

 

EUDAMED database

The European Database on Medical Devices (EUDAMED) will be significantly expanded and manufacturers will be obligated to submit data on the vigilance of their products.

 

Unique Device Identification (UDI)

Each medical device must receive a unique identification number (UDI) in the future.  You can find more information on the MDR Compliance in our article MDR UDI – the EU follows suit.

 

Re-accreditation of notified bodies

The requirement for notified bodies is also increasing. Another sharp reduction in the number of notified bodies is therefore expected, if they have to decide on the application for re-accreditation according to MDR Compliance guidelines.

 

MDR Compliance - Medical Device Regulation

Graph: The new MDR will take effect in May 2017. Manufactures will be granted a transitional period of three years.

 

The transition period for the MDR is 3 years. The final version of the EU regulation is available in various languages.

Stay informed – by registering for free to receive our UPDATE newsletter, you will learn more details about the MDR and will always be up to date on compliance for medical devices.

 

Do you have questions regarding the new medical devices regulation, or do you need support in the implementation? Our experts will be glad to assist you!

MDR Compliance - Medical Device Regulation - Rob Stijlen

Your Contact:

Rob Stijlen

Sales Manager

Tel: +41 61 717 82 00
Email: rob.stijlen@arcondis.com