2018

EU Parliament asks Commission how they will avoid potential market disruption due to MDR/IVDR and to clarify Brexit impact
2017/07/10
2018/06/18

2018/06/20

New version of the Borderline Classification Manual published
2018/04/23

Technical report 17223:2018
2018/03/21

Brexit Transition Period Proposed
2018/03/19

HPRA's Guide for Medical Device Distributors!
2018/02/14

Brexit Impact clarification!
2018/01/22

CAMD Publishes FAQs!
2018/01/17

New version of the Swiss Medical Device Ordinance
2018/01/12

New version of the Borderline Classification Manual published - OUTDATED see Qarad's newsitem 2018/04/23
2018/01/09

Phase-Out of HCP/O Direct Sponsorship!

2018/01/03

Build your relationship with your Notified Body (Bodies)!
2018/01/02

2017

Notified Body Designation Process
2017/11/29

Implementing Regulation on Notified Body Designation Codes published
2017/11/23

Qarad now ISO13485:2016 certified!
2017/11/23

EU Commission published titles and references of harmonised standards under Union harmonised legislation
2017/11/17

Competent Authorities publish IVD-R and MD-R Roadmap
2017/11/07

First draft Implementing Regulation
2017/09/27

Change of Belgian Competent Authority for In vitro Diagnostic Medical Devices
2017/08/07

Impact of the new IVD-R and MD-R on eIFUs
2017/05/22

Publication of the IVD-R and MD-R
2017/05/05

What are “Delegated and Implementing Acts”?
2017/02/15

2016

New European Data Protection legislations

2016/12/12

The new ISO 13485: the 2016 version
2016/03/18




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