In vitro diagnostics

mi-CE consultancy: your regulatory compliance consultant for Medical Devices, In Vitro Diagnostics, CE marking, Clinical Evaluation and Clinical Trial Design.

[Regulatory Affairs Professionals Society @RAPSorg]

Great insight into preparation for EU #IVDR in today's #RAPSEuroConvergence IVDR Fireside Debate with experts from @EMA_News, @TUVSUD, @NSAI_Standards, @AbbottGlobal and @Qserve_Group

[Regulatory Affairs Professionals Society @RAPSorg]

Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night | #Regulatory Focus https://t.co/89yfbM0CxP

[Voorzitter NVKF @VoorzitterNVKF]

Op 21 mei 2021 wordt de MDR van kracht. In deze leidraad staat beschreven welke gevolgen dat heeft voor de toetsing van onderzoek met medische hulpmiddelen door de erkende medisch-ethische toetsingscommissies (METC’s) @de_specialisten
https://t.co/5mlGpHmyjK

[MedicalDevicesLegal @MedDevLegal]

The urgency with #IVDs under the EU #IVDR
#medicaldevices #medtech #dx #diagnostics #invitrodiagnostics https://t.co/Dkv57gFkgp

[Dr. Bassil Akra @dr_akra]

Now it is finally there... Check the website of the EU Commission and use the additional year till 26 May 2021 to implement those new documents. It is nice to see that we are getting slowly all needed instruments to finalize implementation steps towards t…https://t.co/1pZWD7k1Z2

[Connie Del Buono @Synoptyx]

APRIL #MDR #MDCG Guidances, Timely on #ventilators +their accessories, clarified Art. 54(2)b devices exempt from pre-market clin. eval. consultation and Sufficient Clin Evidence-Legacy Devices, Clin Eval- Equivalence, PMCF Plan & Eval Report Template

https://t.co/JkxuvtCHeQ

[Regulatory Affairs Professionals Society @RAPSorg]

MDR delay moves forward as industry calls to push back IVDR | #Regulatory Focus https://t.co/6qLNxqNHRs

[Dr. Bassil Akra @dr_akra]

Important NEWs - New Date to keep in mind 26 May 2021

Now the delay of the date of application of the EU MDR 2017/745 is published in the official journal of the EU Commission:

Learn more about this change and other news from th…https://t.co/Wmx62RK0s7 https://t.co/xlCD8vQCt3

[Regulatory Affairs Professionals Society @RAPSorg]

COVID-19 IVD quality problems drive EC guidelines | #Regulatory Focus https://t.co/JnS72XIHRV

[Stella Kyriakides @SKyriakidesEU]

Vital devices needed to treat #COVID19 patients must remain available on 🇪🇺 markets. For that reason, at the @EU_Commission, we are working to put forward a proposal to delay the implementation of the new medical devices Regulation by 12 months.

[Regulatory Affairs Professionals Society @RAPSorg]

How Prepared Are You for the EU In Vitro Diagnostics Regulation (EU IVDR)? Take our 10-minute survey, and for participating, you will receive a complimentary copy of the final survey report. https://t.co/inbJsvKNWx

[Karla van Rooijen @KarlavanRooijen]

Wil iedereen dit bericht zoveel mogelijk delen. Deze informatie klopt. We hebben mondkapjes en mondmaskers hard nodig voor de zorgverleners die het echt nodig hebben! https://t.co/mRD2Tgr2kC (via @NUnl)

[Regulatory Affairs Professionals Society @RAPSorg]

With EU Medical Device Regulation Deadline Looming, Regulatory Pros to Gather in Brussels for RAPS Euro Convergence | #Regulatory Focus https://t.co/UkD6V1pNWz

[Voorzitter NVKF @VoorzitterNVKF]

Strengere Europese regels voor medische hulpmiddelen brengen ziekenhuizen in problemen. Naast productveiligheid moet ook de productbeschikbaarheid geborgd worden! @de_specialisten @volkskrant
https://t.co/f8D3igZK57

[Voorzitter NVKF @VoorzitterNVKF]

Stevig en terecht signaal van @nvzziekenhuizen en NFU vandaag in @FD_Nieuws over gevolgen MDR. @MinVWS moet hierin regie nemen, medisch technologie bedrijven niet transparant, willen hun eigen positie niet in gevaar brengen. @de_specialisten
https://t.co/6YqRQ55l02

[Regulatory Affairs Professionals Society @RAPSorg]

European Parliament Signs Off on Second Round of MDR, IVDR Corrigenda | #Regulatory Focus https://t.co/VjjPMEBfV8

[MedicalDevicesLegal @MedDevLegal]

#Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices
#medtech https://t.co/d5Htld3TM8

[MedicalDevicesLegal @MedDevLegal]

#Eudamed delayed, but #MDR not delayed - now what?
#medicaldevices #medtech #IVDR https://t.co/2I6R1IRYGI

[Dr. Bassil Akra @dr_akra]

It seems that the EU Commission is keeping their promises and making the waves 🌊 of designation happening. Congratulations for BSI in the Netherlands, we are happy having you on the list of MDR Notified Body. We need more and more notified bodies to secu…https://t.co/XCXId8zZds

[Regulatory Affairs Professionals Society @RAPSorg]

We are excited to announce our 2nd Annual Regulatory Conference
in Brussels — 2020 Euro Convergence! Visit our website https://t.co/VzQO6A3qxl https://t.co/QFpIF7ss4J