VLF Consulting

📣 📣 new exciting opportunities! We are looking for a QA&RA Consultant for our headquarter! 📣 📣

Good morning dear followers! Yesterday, 11 September 2024, Team NB released the document: "TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES- specifying the terms of the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/746 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC". This document provides that a valid certificate under Directive 98/79/EC, issued by the "OUTGOING" NB, continues to be valid in accordance with paragraph 2 of Article 110 of Regulation (EU) 2017/746, i.e. where there is a written agreement with an NB, and that the manufacturer is subject to appropriate surveillance activities with respect to the applicable requirements under Article 110 (3e) of Regulation (EU) 2017/746 by the NB INCOMING. Appropriate surveillance may include, for example, examination of documentation, audits or other types of assessments carried out by a notified body in relation to a pre-existing device under the previous conformity assessment procedure of the CERTIFICATION HOLDER under Directive 98/79/EC.  The agreed date on which the review activities by the INCOMING NB in accordance with § 4 of the TRANSFER AGREEMENT are to be completed and as of which the surveillance activities by the INCOMING NB are to be performed and the responsibility for appropriate surveillance assumed by the INCOMING NB is hereafter referred to as the ‘TRANSFER DATE’ and is specified in Appendix 1. The TRANSFER DATE shall not exceed 26 September 2025. The written agreement referred to above, specifies the terms and modalities for the transfer of appropriate oversight from an OUTGOING NB to an INCOMING NB in accordance with Regulation (EU) 2017/746 and other relevant scheme requirements set out at the end of this Agreement (see the section ‘Overview of Provisions Covered or Taken into Consideration in this Agreement’) and ensures the continuity of appropriate oversight activities between the OUTGOING NB and the INCOMING NB in accordance with such requirements. Source: https://lnkd.in/dgKsmkf #ivdd #ivdr #ivd #OUTGOINGNB #INCOMINGNB #TRANSFERAGREEMENT #legacydevices #qualityassurance #regulatoryaffairs #vlfconsulting

Good morning dear followers! Today I bring you good news in the IVD field: the 13th notified body to certify IVDs according to Regulation EU 746/2017 has been notified and it is the very Italian Istituto Superiore di Sanità - ISS. What more can I say? Welcome and above all good luck! Source: https://lnkd.in/dmiZA7B4 #ivd #notifiedbodiy #ivdr #iss #13th #qualityassurance #regulatoryaffairs #vlfconsulting

Dear followers, good morning! I would like to report that on 29 August, the EMA released the document "Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities" with the aim of providing guiding principles on the use of large language models (LLMs) in general use in regulatory science and for medicines regulatory activities, and to provide high-level recommendations to regulatory authorities to facilitate the safe, responsible and effective use of LLMs. LLMs are a category of generative AI, whose applications can significantly support medical regulators in their tasks and processes.  Whether used to interrogate the vast documentation that regulators routinely receive, to automate knowledge/data mining processes or as virtual AI assistants in day-to-day administrative tasks, LLMs have enormous transformative potential. However, LLMs also present challenges, e.g. variability in results, the return of irrelevant or inaccurate responses (so-called hallucinations) and potential data security risks.  Therefore, the EMA has drafted this document in order for the staff of regulatory agencies across the EU to understand the capabilities and limitations of these applications, so that they can effectively exploit the potential of LLMs and avoid pitfalls and risks. Source: https://lnkd.in/d9sZsuyT #EMA #guidingprinciples #LLM #AI #risks #limitations #qualityassurance #regulatoryaffairs #vlfconsulting

Good morning dear followers! In June 2024, the European Union signed the Artificial Intelligence (AI) Act into law. The AI Act was published in the Official Journal of the EU on 12 July 2024. It came into force in August 2024. This AI Act is the first globally binding horizontal legislation on AI and establishes a common framework for the use and provision of AI systems in the EU. The new act offers a classification for AI systems with different requirements and obligations adapted to a ‘risk-based approach’. Some AI systems that present ‘unacceptable’ risks are banned. A wide range of ‘high-risk’ AI systems, which may have a negative impact on people's health, safety or fundamental rights, are authorised, but subject to a number of requirements and obligations for access to the EU market. AI systems that present limited risks due to their lack of transparency will be subject to information and transparency requirements, while AI systems that present minimal risks to individuals will not be subject to further obligations. The regulation also sets specific rules for general purpose AI (GPAI) models and establishes stricter requirements for GPAI models with ‘high impact capabilities’ that could pose a systemic risk and have a significant impact on the internal market. It should be noted that this law takes into consideration medical devices that integrate an AI within them and not only, and MDCGs on the topic are likely to be issued by the Expert Group. Source: https://lnkd.in/gCAQS4X #AI #europeanparliament #risk #mdcg #medicaldevices #ivd #qualityassurance #regulatoryaffairs #vlfconsulting

Good morning followers! Today, 4 September 2024, the MDCG - International Issues Subgroup Meeting will be held from 9.30 am to 4 pm. During this meeting many topics will be discussed, including the IMDRF Working Groups - Status and Discussion: a) Adverse Event Terminology (AET) b) Good Regulatory Review Practice (GRRP) c) Customised medical devices (PMD) d) Presentation of regulated products (RPS) (e) Software as a medical device (SaMD) (f) Quality management systems (QMS) (g) Artificial intelligence/machine learning (AI-ML) (h) Clinical evidence for in vitro diagnostic medical devices (CE-IVD) But above all, multilateral cooperation and bilateral relations will be discussed (IMDRF and MDSAP). Source: https://lnkd.in/ekASJpwG #europe #mdsap #imdrf #mdcg #draftagenda #subgroupmeeting #md #ivd #qualityassurance #regulatoryaffairs #vlfconsulting

Dear followers September 26 is coming! We would like to remind you that according to Regulation (EU) 2023/607 the last chance to take advantage of the extension of the transitional period under the MDR is September 26, 2024. It is necessary for the Manufacturer has signed the written agreement with the Notified Body, as after that date, in the absence of a contract, the MDD-certified device is no longer marketable and will not become a legacy device. Source: https://lnkd.in/dPtNjkQF #regulation #medicaldevices #legacydevices #mdr #manufacturers #notifiedbodies #writtenagreement #mdd #qualityassurance #regulatoryaffairs #vlfconsulting

Dear followers! The European Commission has prepared the document “Factsheet for Authorized Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices.” The document explains how the Regulations (MDR and IVDR) clarify the respective responsibilities of authorized representatives, importers and distributors, as well as the tasks that can be delegated by the legal manufacturer to the authorized representative. The Regulations emphasize a life-cycle approach to safety, adding requirements for pre-marketing clinical trials and enhanced post-marketing monitoring (“vigilance” and “post-marketing surveillance”). In addition, the new Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) align EU legislation with technical advances, evolving medical science, and legislative progress. The new regulations create a robust, transparent, and sustainable regulatory framework that is internationally recognized, improves clinical safety, and creates fair market access for manufacturers. This factsheet aims to explain what the responsibilities and obligations of Authorised Representatives, Importers and Distributors inherent in the Regulations will be during the lifetime of medical devices. Source: https://lnkd.in/gySdxPju #europeancommission #authorisedrepresentatives #importers #distributors #medicaldevices #invitrodiagnosticmedicaldevices #md #ivd #lifetime #responsibilities #mdr #ivdr #qualityassurance #regulatoryaffairs #vlfconsulting

Dear Followers. As you may know, AI is becoming an increasingly important technology in many areas, including medical devices. The European Commission has released a question and answer document with respect to the use of AI. Source: https://lnkd.in/dTrHbrJ3 #ai #europeancommission #qanda #medicaldevices #qualityassurance #regulatoryaffairs #vlfconsulting

Dear Followers Swissmedic has published the guide “Information sheet 3D printers medical devices” dated August 13, 2024. Development in the field of 3D printers is also gaining importance in medical technology. The different areas of application and use of such 3D printers raise complex questions regarding the legal liability of medical devices manufactured in this way.  This paper is intended for manufacturers and users of medical devices using 3D printing technology and provides guidance on the most relevant legal bases. Source: https://lnkd.in/d5AHmJV4 #swissmedic #3Dprinters #medicaldevices #manufacturers #legalliability #newapproach #newtechnology #qualityassurance #regulatoryaffairs #vlfconsulntig