EU - New Medical Devices Regulations agreed upon!

[Ronen E]

The new MDR will probably come into effect this year.

Thank you Erik for keeping us updated through the years.

https://medicaldeviceslegal.com/2016/05/25/breaking-eu-agreement-on-new-mdr-and-ivdr/

 

[RobertvanBoxtel]

For those trying to find background information, please look on this site:
http://www.consilium.europa.eu/en/policies/new-rules-medical-in-vitro-diagnostic-devices/

 

[Yasuaki]

So, we must gain four new certificates in a couple of years, if necessary.
ISO 9001:2015 Certificate by 2018
ISO 13485:2016 Certificate by 2019
MDSAP Certificate by 2019
MDR Certificate by 2019 or 2020

Many people engaging audit and/or certificate may be going to get heavily tired.

 

[Ronen E]

Some more details / heads up from the EU council:

http://www.consilium.europa.eu/en/press/press-releases/2016/05/25-medical-devices/

 

[Ajit Basrur]

So, we must gain four new certificates in a couple of years, if necessary.
ISO 9001:2015 Certificate by 2018
ISO 13485:2016 Certificate by 2019
MDSAP Certificate by 2019
MDR Certificate by 2019 or 2020

Many people engaging audit and/or certificate may be going to get heavily tired.

Very true