Roman Anton’s Post

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.

🔍 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

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

The European Commission have announced a proposal to extend the time that manufacturers have to apply the IVDR (In Vitro Diagnostic Medical Devices Regulation) which is great news for manufacturers and patients. This will help keep existing products on the market and available.   Safety of currently available devices is key, The proposed transition periods are as follows   ·        December 2027 (class D) ·        December 2028 (Class C) ·        December 2029 (class B)   This proposal will now be put forward to the European Parliament and Council for adoption. https://lnkd.in/eHB3Yh6V

The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs) for patients and healthcare providers. These measures include granting more time to companies to transition to the new EU rules on IVDs, introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices and allowing for the gradual roll-out of the European Database on Medical Devices - Eudamed. The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market.

Commission proposes measures to improve the availability of in vitro diagnostics Yesterday, 23 January 2024 Brussels Concerned that in vitro diagnostic manufacturers don’t have enough time to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the European Commission (EC) has again proposed extending the regulation’s transition period. At the same time, the Commission has proposed to accelerate the timeline for complying with EUDAMED requirements, by making the use of finalized modules mandatory on a gradual basis.   While IVDR entered into force in May 2022, the transition periods for diagnostics to comply with the regulation were extended in late 2021 amid pressure from industry and fears of a market collapse for diagnostics. At the time, the EU extended the transition periods to 26 May 2025 for high-risk IVDs, 26 May 2026 for moderate-risk IVDs, and 26 May 2027 for lower-risk IVDs. The Commission now said it wants to give manufacturers more time, as a significant number of IVDs on the market have not yet taken the necessary steps to come into compliance.   “The situation is especially critical for high-risk IVDs, which are devices used, for example, to test for infections in blood and organ donations,” the Commission said. “To improve the availability of such essential devices, today's proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements.”   “This is very important, also taking into account the fact that many manufacturers producing IVDs are small and medium size enterprises [SME],” the Commission added.   Under the new proposal, high-risk class D diagnostics would get until December 2027 to undergo a conformity assessment under IVDR; class C, or high individual and/or moderate public health risk tests, will have until December 2028, and low risk class A sterile and class B tests would have the deadline extended to December 2029.   The proposal requires companies to warn the authorities if they anticipate an interruption to the supply of IVDs or medical devices at least six months prior, so that member states can respond faster to potential product shortages.   Link : https://lnkd.in/gHyw8rq8 #RIwithRohitT #ema #regulatoryaffairs #regulatoryintelligence

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 

This week the EU Commission proposed an amendment to IVDR transitional provisions to allow for a further 2 years for each class of device that requires Notified Body involvement. Additionally there is the provision to extend the validity of IVDD certificates until 2027 if certain conditions are met. If this proposal passes into legislation it is imperative that manufacturers use this added time to strategically transition to IVDR. Since BSI was designated to IVDR at the end of 2019 we have received many requests from a wide variety of manufacturers to explain how various processes will work. While we will explain as best we can within the limitations of what we are able to do and the scarcity of IVDR written guidance there is no substitution for manufacturers experiencing it for themselves! 💡 It may be challenging but there is a strategic case for getting at least some of your devices transitioned well before the deadlines. 📜 The IVD manufacturers in the best position to get a new innovative device onto the European market are the ones who already have an IVDR certificate and understand how to interact with a Notified Body. 💲 If a manufacturer learns the lessons from the gaps identified during their first NB technical documentation review, the second review nearly always goes more quickly and with less deficiencies identified. 💊 Those manufacturers who have already experienced EMA CDx consultation are in a stronger position to confidently plan their new CDx clinical performance studies. 🔓 If your Class D devices are already being batch released by a Notified Body we will be able to accurately plan transition into EURLs when they are operational. 🏵 If you are not sure a Notified Body will agree with the classification of your device the Classification Dispute process escalates the issue to Competent Authorities so that stakeholders can learn and align. 🛩 There is no point having a longer runway to do something if you do not use it! https://lnkd.in/eWtfdXJp

Worth a read from #NB #IVDR #BSI… IVD Manufacturers should take on board these insights in order to effectively keep devices on the EU market. Any transition delays should not mean slowing your planning and progress towards IVDR! If you self-certify an IVD against the old IVDD for CE marking, you have actions to do now to stay in compliance and not get caught out in the future! #IVD #IVDR #dontdelayprogress #CE #MCRA #consulting