Commission for the Protection of Competition of the Republic of Cyprus’ Post

https://lnkd.in/dPXQj5Mf Commission report finds active competition enforcement continues to contribute to affordable and innovative medicines Report on competition enforcement in the pharmaceutical sector 2018-2022 

The European Commission published the Science, Research and Innovation Performance Report. The report highlights: ➡ EU research & innovation ecosystem (R&I) remains underutilized ➡ Divide in R&I for activities/support ➡ Gap with the rest of the world raising private investments The report offers several recommendations: ➡ Improve the sector of research universities ➡ Allocate a fraction of R&I funds to government research labs and introduce accountability reforms ➡ Create an Advanced Research Projects Agency for Health (ARPA) modeled after the US ARPA-H Read more > https://hubs.li/Q02Fw8Qv0 #ResearchAndInnovation #pharmaceutical

The European Commission published the Science, Research and Innovation Performance Report. The report highlights: ➡ EU research & innovation ecosystem (R&I) remains underutilized ➡ Divide in R&I for activities/support ➡ Gap with the rest of the world raising private investments The report offers several recommendations: ➡ Improve the sector of research universities ➡ Allocate a fraction of R&I funds to government research labs and introduce accountability reforms ➡ Create an Advanced Research Projects Agency for Health (ARPA) modeled after the US ARPA-H Read more > https://hubs.li/Q02FwbZR0 #ResearchAndInnovation #pharmaceutical

🔍 European Parliament Extends IVDR Compliance Deadlines 🔍 🇪🇺 The European Parliament has adopted measures to give IVD firms more time to meet the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements, providing a phased introduction of the European Database on Medical Devices (Eudamed). 📅 Key Timelines: 👉High risk devices: Compliance by Dec 2027 👉Moderate risk devices: Compliance by Dec 2028 👉Lower risk devices: Compliance by Dec 2029 👉Mandatory use of Eudamed parts starting 2026 🤔 This development is especially noteworthy as we anticipate the upcoming FDA LDT rule, which is expected to include aggressive timelines. https://lnkd.in/dpm8_SCG #Healthcare #IVDR #MedicalDevices #RegulatoryUpdate #Eudamed #FDA

EU Medical Device and IVD Regulatory News + + + Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics - amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices -The council now still needs to formally adopt the amending regulation #eudamed #supplychain #ivds #IVDR #QM #RA #adopted https://lnkd.in/d5cs-QZ5

Big News!! 🙂 Today, the European Commission proposed: - new transitional provisions for IVD manufacturers to comply with the IVDR (December 2027, 2028 and 2029 depending on the risk class of the device - the requirement for manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices - the mandatory use of EUDAMED from late 2025 for the modules already finalised #MDR, #IVDR, #transition #EUDAMED, #supplychains

EUDAMED speed-up ⛷ : Today's proposal of the European Commission aims to launch parts of EUDAMED that are already finalised earlier than previously thought. There will be a gradual roll out of all six modules between Q4/2024 and 2026, with mandatory use delayed untill there’s confirmation on full functionality (2027-2029). Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. The mandatory use of the European database on medical devices, EUDAMED, is key for the effective and efficient implementation of the Medical Device and IVD Regulations. It will increase transparency in the EU, providing an overview of all medical devices available on the European market.

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26/01/2024 Commission report finds active competition enforcement continues to contribute to affordable and innovative medicines #CompetitionLaw# #PharmaceuticalSector##