💡 Un estudi liderat pel #VHIO, presentat al congrés @myesmo.bsky.social, copresidit per Elena Garralda, analitza l’impacte de la normativa #IVDR en els assajos clínics per agilitzar l’accés dels pacients a teràpies innovadores. 🧬

➡️ https://linke.to/ESMOTAT26VHIO_Cat
#UITM @caixaresearch.bsky.social

💡 Un estudio liderado por VHIO, presentado en el congreso @myesmo.bsky.social, copresidido por Elena Garralda, analiza el impacto de la normativa #IVDR en los ensayos clínicos para agilizar el acceso a terapias innovadoras.
➡️ https://linke.to/ESMOTATVHIO26_Cast
#UITM @caixaresearch.bsky.social

💡Last week at #ESMOTAT, co-chaired by Elena Garralda, the VHIO study on the impact of #IVDR on clinical trials was highlighted by the congress @myesmo.bsky.social, addressing key challenges in patient access to innovative therapies.

➡️ https://linke.to/ESMOTAT26VHIO

#UITM @caixaresearch.bsky.social

Seltene Erkrankungen: IVDR-Reform könnte Diagnostik sichern Anlässlich des Tags der Seltenen Erkrankungen am 28. Februar macht der Verband der Diagnostica-Industrie e.V. (VDGH) auf die besondere Bedeutung einer verlässlichen und verfügbaren Labordiagnostik auf...

Für #SelteneErkrankungen existieren oft nur einzelne, hochspezialisierte diagnostische #Tests. Damit diese nicht vom Markt verschwinden, begrüßt der VDGH die geplante Reform der #IVDR. #InVitroDiagnostik

BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies for #diagnostics apps such as #immunohistochemistry & #immunofluorescence to detect many #cancer types infectious diseases autoimmunity & other #pathologies

🔗https://www.stratech.co.uk/biosb/immunohistochemistry-2

#NMI -Expertise beim #Regulatorik -Forum: Bei der 1. Ausgabe der #regularia sind wir dabei und zeigen, wie das Kompetenzzentrum #MIK innovative #KMU unterstützt, die Regularien von Anfang an mitzudenken.

Wir begrüßen Sie gerne am Stand 22!

#Medizintechnik #MDR #IVDR #angewandteForschung

EU Tightens Cybersecurity Requirements for Medtech - MDR and IVDR The EU is strengthening cybersecurity requirements in MDR and IVDR. Manufacturers must embed cybersecurity from the start, document processes, and ensure security throughout the entire device lifecycl...

Cybersecurity in #MedTech is no longer something you "add later."
Under #MDR / #IVDR, security is a prerequisite for market access, not an optional feature.
When addressed too late, the result is rework, delays, or products that never make it to market.
Read more: www.assured.se/areas/medtec...

EU moves to fix failing medical and in vitro device rules and spur innovation A 'targeted' revision to the MDR and IVDR promises clearer timelines, proportionate oversight and faster access to innovative technologies

Europe’s medical device rules were introduced after safety scandals, but they've proved cumbersome and costly causing shortages. The Commission is proposing course-correction, but might they need a more radical revamp? #MDR #IVDR #MedicalDevices
🔗 www.vitalsigns.news/eu-moves-to-...

BD Expands BD MAX™ System with New VIASURE Assays to Enhance Diagnostics BD has introduced new IVDR-certified VIASURE assays for the BD MAX™ System, expanding its respiratory and STI diagnostics offerings. This partnership with Certest Biotec enhances rapid pathogen detection.

BD Expands BD MAX™ System with New VIASURE Assays to Enhance Diagnostics #USA #Franklin_Lakes #IVDR #BD_MAX™_System #VIASURE

✨ We’re proud to have #AGES on board, helping us navigate the regulatory landscape and paving the way for trustworthy, future-proof AI-driven imaging technologies.

#AutoPiX #RegulatoryScience #AIinHealthcare #MDR #IVDR #MedicalDevices #DigitalHealth #Innovation #IHI

🚀 BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies for #diagnostics app's such as #immunohistochemistry & #immunofluorescence to detect many #cancer types, infectious diseases, autoimmunity & other #pathologies

🔗www.stratech.co.uk/b...

Delegationsbesuch aus Südostasien heute am #NMI: Forschende des Instituts stellten den Firmenvertreter:innen ihre Arbeit zu #Krebsdiagnostik, an #Biologicals, zu Fragen der Regulierung ( #MDR #IVDR) sowie zu Digitalisierung vor.
#Netzwerken #angewandteForschung

picture of a one dimensional proton NMR spectrum of human plasma

Good to be up and running plasma samples in 3mm mode within specs again! #nmr #nmrchat #ivdr

📢#BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies

for #diagnostics applications:
#immunohistochemistry & #immunofluorescence to detect many #cancer types, infectious diseases, autoimmunity & other #pathologies

🔗tinyurl.com/8w4xwbt8

#MDR & #IVDR, Sauberkeit von Medizinprodukten und Forschung zu #Wundmonitoring: Dagmar Martin, Kai Fuchsberger & Fabian Körte freuen sich auf spannende Gespräche auf der Swiss Medtech Expo am Gemeinschaftsstand von Medical Mountains.
Kommen Sie gerne vorbei!
#NMI #smte25 #angewandteForschung

Expertise zusammenzuführen ist das Ziel der Kompetenzzentren am #NMI. Sie bieten Angebote und Forschung, vor allem für #KMU, zu #Biologicals, #Nanoanalytik, Zulassung von #Medizinprodukten und Alternativen zu #Tierversuchen.
#40JahreNMI #NMIGeschichte #Nanoanalytik #MDR #IVDR #3R #NAM #Biologicals

#NMI auf der Swiss Medtech Expo: In Luzern präsentieren wir unsere Expertise bei #MDR- & #IVDR -Regelungen, Sauberkeit und Wundmonitoring. In einer Keynote stellt zudem Dagmar Martin ein neuartiges Gewebemodell vorbei. Kommen Sie vorbei! Wir freuen uns auf Sie!
#smte25 #angewandteForschung

The Medical Device Regulation (#MDR) and In Vitro Diagnostic Regulation (#IVDR) are key pillars in enhancing patient safety across the EU. | LISAvienna The Medical Device Regulation (#MDR) and In Vitro Diagnostic Regulation (#IVDR) are key pillars in enhancing patient safety across the EU. By ensuring that only safe, effective, and high-quality medic...

Join Martin Schmid, en.co.tec, at #REG25 for an update on #MDR and #IVDR. He explores the tensions between market shakeout and regulatory postponement, and discusses how the medtech industry can – and should – respond to the evolving regulatory landscape.
www.linkedin.com/feed/update/...

📢 #HealthierEurope. Better access. ESMO welcomes the @ec.europa.eu ’s Life Sciences Strategy - a bold step to reform #IVDR & support clinical innovation. Let’s ensure Europe leads in life sciences & #PatientsCare.
🔗 buff.ly/34j9638

The European Commission recently wrapped up its public consultation on the #IVDR.

Curious how industry stakeholders responded and what it means for the future of diagnostics in the EU?

Take a closer look into the key takeaways from the consultation - lp.diaceutics.com/latest-ivdr-...

Have you been keeping up with the latest updates on #IVDR?

Recently, the EU commission ran a public consultation exercise requesting feedback on the IVDR and MDR.

We have provided an in depth analysis of the feedback received which you can access here: lp.diaceutics.com/latest-ivdr-...

DNV Earns Recognition as Notified Body Under European In Vitro Diagnostic Regulation DNV has been acknowledged as a notified body for In Vitro Diagnostic Regulation by the European Commission, enhancing market access and transparency for device manufacturers.

DNV Earns Recognition as Notified Body Under European In Vitro Diagnostic Regulation #Medical_Devices #Norway #Oslo #DNV #IVDR

Join us for the EuroGentest Online Seminar on April 1, 2025 (1-4 PM CET)!

Get updates on #IVDR, quality assurance, professional recognition & best practices in genetics. Program: buff.ly/5XYNVt8

The webinar is free but registration is mandatory: buff.ly/gCq6ita

To document or not to document? General laboratory equipment under IVDR - Platomics Pipettes, centrifuges and the spin cycle of compliance General laboratory instruments, also known as GLUs (devices for General Laboratory Use), have a somewhat murky status under IVDR Article 5.5…

General laboratory equipment under #IVDR
Pipettes, centrifuges and the spin cycle of compliance

Ratatouille réglementaire au labo: IVDR, ISO 15189 et cie - Platomics La norme ISO 15189 n’est qu’un ingrédient dans la recette complexe de la conformité IVDR. Les laboratoires possédant des dispositifs internes

Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.

Register: buff.ly/4hOK4ML

#IVDR

Access the latest #IVDR report along with 2024 updates!

Keep your eyes peeled as we bring you 2025 updates soon 👀

#medsky #oncsky #moleculartesting

More bread and butter, please: Risk management under IVDR  - Platomics How labs might deliver on a rather tall order  The IVDR has reshaped lab compliance and— let’s just admit it—put out a tall order for labs to serve up. One aspect that proves particularly…

Risk management under #IVDR
How #labs might deliver on a rather tall order

The IVDR has reshaped lab compliance and put out a tall order for labs to serve up. One aspect that proves particularly exasperating is a much stronger emphasis on rigorous risk management.

Not sure how to begin #IVDR documentation of your in-house tests?

Our interactive wizard will get you started with basic IVDR know-how and then lead you straight to the right strategy for your lab.

Click here: https://buff.ly/4gKEzNF

Platomics Inks Deals With Sophia Genetics, Agilent for Automated IVDR Compliance Documentation Through the collaborations, customers of Sophia Genetics and Agilent Technologies can use Platomics' platform to prepare documents for IVDR compliance.

Platomics Inks Deals With Sophia Genetics, Agilent for Automated #IVDR Compliance Documentation
via @genomeweb.bsky.social

Read more:

For Manufacturers - Platomics Platomics regulatory services and the PlatoX® platform simplify and accelerate compliancefor your lab customers

Our lab solutions also benefit #manufacturers!
#IVDR

EU labs and IVD manufacturers are both subject to strict new IVDR requirements. Labs are now considered the manufacturer of their in-house tests.