News archive

2022

New MDCG Guidance documents released!
2022/01/27

IVDR Amending Regulation Published!
2022/02/02

New MDR and IVDR harmonised standards published!
2022/01/06

2021

Progressive roll-out of IVDR adopted!
2021/12/20

New MDCG Guidance documents released!
2021/12/20

Implementing Regulation eIFUs for Medical Devices!
2021/12/14

Implementing Regulation on EUDAMED
2021/11/26

Progressive roll-out of IVDR proposed!
2021/10/14

EUDAMED UDI/Devices and NBs & Certificates modules are open!
2021/10/04

New MDCG Guidance documents released!
2021/10/04

EN ISO 13485:2016+A11:2021 published! 
2021/09/10

Another wave of MDCG Guidance documents released!
2021/08/11

First MDR and IVDR harmonised standards published
2021/07/20

New MDCG Guidance documents released!
2021/07/12

ISO 15223-1: 2021 Published!
2021/07/06

New MDCG Guidance documents released!
2021/05/22

European Medical Device Nomenclature (EMDN) + UDI Helpdesk!
2021/05/18

Swiss Third Country Status!
2021/05/12

Updated AER codes published by IMDRF!
2021/03/02

New MDCG Guidance documents released!
2021/04/09

Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?
2021/03/18

Management of Legacy Devices in EUDAMED!
2021/02/15

MDCG 2021-1 What to do while EUDAMED is being built!
2021/02/26

2020

Brexit and the Impact on the IVD and MD Industries
2020/12/08

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

2019

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

2018

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

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