Scout’s Post

🇧🇾 #Belarus repealed one of the last remaining #COVID19 restrictions in the registration process of #CSOs. The process of approving the name of a CSO can now again be carried out in person. This decreases the possibility of arbitrary barriers to new initiatives. While this is a good step for #FreedomOfAssociation, civil society in Belarus continues to operate in a highly restricted environment. Read more in the #CSOMeter update: https://buff.ly/3wByxhj

Today 4 September 2024, the meeting of the Subgroup on #International matters of the Medical Device Coordination Group (#MDCG) takes place, with the European Commission EU Health and Food Safety DG #SANTE services in charge of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR), the #MemberStates #CompetentAuthorities (#Regulators) and the sectorial #Stakeholders. In the agendas of the sessions, topics on Multilateral cooperation (#IMDRF and #MDSAP), Bilateral relations and other issues of interest. The draft agendas are available on the specific space of the "Register of Commission Expert Groups and Other Similar Entities" (#RegExp) https://lnkd.in/eSXZ_VXw where also other relevant documents will be added in due time.

Want to know what people are asking for? FOIA is your right to know. Knowledge you gain from FOIA will be an asset to you and improve patient safety Here’s what people look for https://lnkd.in/g2jSWeDH

A short video summarises the editorial, 'Mapping the landscape of medical assistance in dying through exploring barriers and facilitators among providers in Canada'. Watch video: https://ow.ly/xFi850QGwIR #JBIEBHC

Attention: Please be informed that the TGA Essential Principles Checklist has undergone recent updates. Manufacturers must demonstrate evidence confirming their devices' alignment with the Essential Principles (the Principles). This evidence should directly relate to the device's intended purpose and uphold standards of objectivity, comprehensiveness, and robustness. Of notable mention in the updated Guidance is the explicit requirement for the checklist to incorporate references to evidence of compliance, including the actual document numbers. This stipulation ensures transparency and precision regarding the evidence substantiating compliance with the Essential Principles. #tga #medicaldevice #medicaldevices #regulatoryaffairs https://lnkd.in/e3_FHpVp

 Last day for manufacturers to sign a written agreement with a notified body to benefit from extended transitional periods + end of the possibility to continue placing MDD/AIMDD certified devices on the market (unless meeting conditions for extended transitional periods)= Devices not compliant with MDR and not meeting conditions for extended periods must be withdrawn from the market!!!

This week's Brexit & Beyond is out https://lk.nia.fyi/MzQe with the latest on the Windsor Framework and supply/regulation of medicines and medical devices in NI; the first report of the Windsor Framework Democratic Scrutiny Committee; the European Parliament elections and more #Brexit #Windsorframework #medicines

On 9 July, the EU Commission published Regulation (EU) 2024/1860 on the OJEU. Check out the new IVDR transition timeline and visit our dedicated IVDR webpage: https://gag.gl/J7hVdw #BSI #MedicalDevices #IVDR #AmendingRegulation #Timeline

🔍 Navigating the Regulatory Landscape for Retrospective Studies in France: Insights for IVD, CDx, and Lab Tests. In the realm of in vitro diagnostics (IVD), companion diagnostics (CDx), and laboratory tests, the legal framework in France has evolved to support the ethical use of retrospective patient data in research. Understanding these regulations is crucial for researchers and healthcare professionals aiming to leverage existing data for new insights. 💡 Key Regulatory Steps: Ethical Review by @CEREES: Before conducting retrospective research, obtaining an ethical review from the Comité d’Expertise pour les Recherches, Études et les Évaluations dans le domaine de la Santé (CEREES) is essential. This ensures that the study adheres to ethical standards, particularly in non-interventional research. CNIL - Commission Nationale de l'Informatique et des Libertés Authorization (MR004): For research involving patient data, an authorization from the CNIL (Commission Nationale de l’Informatique et des Libertés) is required. Under the MR004 framework, researchers can use data from public directories like INDS without needing explicit patient consent, as long as patients are informed and can opt out. Patient Non-Opposition: Although explicit consent is not required, patients must be informed about the research and given the opportunity to oppose the use of their data. This non-opposition approach ensures respect for patient rights while facilitating valuable research. 📚 Real-World Examples: Retro Care Diagnostics Study: A retrospective evaluation of diagnostic tests that received ethical review and CNIL authorization under MR004. Oncology CDx Study: Leveraged genetic test data to evaluate the performance of companion diagnostics, with all necessary regulatory clearances. National Public Health Study: A large-scale analysis of lab test data across hospitals, adhering to non-interventional research guidelines. In conclusion, while the regulatory landscape may seem complex, understanding these key steps can streamline the process and ensure compliance. By doing so, we can unlock the full potential of retrospective research to drive innovation in diagnostics and patient care. #Healthcare #Diagnostics #Research #IVD #CDx #DataPrivacy #Regulations #France ANSM Agence nationale de sécurité du médicament et des produits de santéé CONFERENCE NATIONALE DES COMITES CONSULTATIFS DE PROTECTION DES PERSONNES DANS LA RECHERCHE BIOMEDICALE Regulation - 2016/679 - EN - gdpr - EUR-Lex (europa.eu) #research #diagnostics #methodology

USFDA NDSRI Limits update -Mar 2024 N-nitroso-varenicline is deleted from table 2 and added in table 1. Now the AI is 400 ng/day while previously it was 37 ng/day. Indeed a good news to industry. Background:- At first, the FDA decided the interim limit of varenicline as 185ng/day aside from 37ng/day. Then the interim limit was lifted because US manufacturers could adequately supply the market with varenicline at or below the acceptable intake limit of 37 ng per day. The 400ng/day is from CPCA and is the same as the limit by EMA. It looks more appropriate than read-across from NTHP(37ng/day). The MDD of Chantix is 2mg. The range of test methods that the FDA recommended is 1-200 ppm. It covers 400ng/day. https://www.fda.gov