EUDAMED Actor Registration Module LIVE! 2020/12/03
MDCG Guidance on IVDR Classification Rules released! 2020/11/13
EUDAMED Actor Registration Module! 2020/10/20
MHRA Guidance on regulating Medical Devices! 2020/09/01
Common Specifications for the reprocessing of single-use medical devices under the MDR! 2020/08/19
EUDAMED Actors Registration Module! 2020/08/18
UDI FAQ! 2020/08/10
ISO Technical Report 20416:2020 Published! 2020/07/08
ISO Technical Report 24971:2020 Published! 2020/06/16
MDCG 2020-12 on devices incorporating a medicinal product! 2020/06/10
Updated MIR Form and Q&A Guidance! 2020/05/15
MDCG Guidance on safety reporting in clinical investigations! 2020/05/13
MDR officially delayed! 2020/04/24
Another wave of MDCG Guidance Documents! 2020/04/23
IMDRF finalises terminology for Adverse Event Reporting! 2020/04/20
MDCG guidance on Notified Body audits during COVID-19 2020/04/08
Proposal to amend MDR 2020/04/03
New 2020 lists of harmonized standards 2020/03/26
Wave of MDCG Guidance Documents 2020/03/17
Swiss MedTech Information Letter 2020/01/20
New documents on EUDAMED nomenclature! 2020/01/10
New MDCG Guidance on cybersecurity 2020/01/07
New MDCG Guidance on MDR/IVDR Sampling and MDR Codes! 2019/12/11
ISO 14971:2019 published 2019/12/10
UDI Technical Documentation. 2019/12/04
2nd MDR corrigenda published 2019/11/25
EUDAMED delayed 2019/10/30
MDCG Guidance on Software Qualification and Classification 2019/10/11
First Notified Body designation under the IVDR 2019/10/10
MIR v7.2 and two new Device Specific Vigilance Guidance 2019/09/30
MDCG Issues Guidance on SSCP 2019/09/27
New version of the Borderline Classification Manual Published 2019/05/22
EC publishes additional Guidance on Vigilance 2019/07/10
UL Ceases as Notified Body 2019/07/08
MDCG Issues Guidnce on PRRC and Implant Cards 2019/07/01
LRQA Ceases as Notified Body 2019/06/13
Implementing Decision UDI Issuing Entities 2019/06/07
ISO 20916:2019 Published 2019/06/06
MDCG 2019-6: NB Q&A 2019/06/06
Medtech Europe publishes MDR symbols guidance 2019/05/06
TÜV SÜD designated under EU MDR 2019/05/22
MHRA Guidance Virtual Manufacturer 2019/04/09
Swiss MedTech Recommendation 2019/04/25
Corrigenda to the Regulations 2019/03/13
Medical Device Nomenclature 2019/03/04
New version of the Borderline Classification Manual published - OUTDATED see Qarad's newsitem 2019/07/11 2019/02/01
No-deal Brexit impact 2019/02/01
EU Commission publishes new MIR Template - OUTDATED see Qarad's newsitem 2019/09/30 2018/12/19 EU Commission publishes new FSN template 2018/11/15 New version of the Borderline Classification Manual published - OUTDATED see Qarad's newsitem 2019/02/01 2018/10/30 EU Parliament debates questions regarding MDR/IVDR implementation 2018/10/25 MDR / IVDR Implementation Rolling Plan 2018/10/17 New MDCG UDI Guidance Documents 2018/10/10 EU Parliament asks Commission how they will avoid potential market disruption due to MDR/IVDR and to clarify Brexit impact 2018/07/10 HIV Self-tests are now also available in Switzerland 2018/06/18 MHRA Guidance on Medical device stand-alone software update 2018/06/20 New version of the Borderline Classification Manual published - OUTDATED see Qarad's newsitem 2018/10/30 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
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
New European Data Protection legislations 2016/12/12 The new ISO 13485:the 2016 version 2016/03/18
You are reading the archive of Qarad's news articles. But Qarad also informs its customers about the most recent changes in the Regulatory IVD and Medical Devices field.
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