NOTICIAS

While interest in generative artificial intelligence (GenAI) tools across the health care sector has expanded rapidly, there remain open questions on the approach to regulating GenAI-enabled products that may fall within FDA’s jurisdiction, including, but not limited...

Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or...

The European Association of Medical devices Notified Bodies (Team-NB) and its members fully support the objectives of the MD and IVD Regulations (MDR and IVDR) which aim to “establish a robust, transparent, predictable and sustainable regulatory framework for medical...

Decorreu no 26 de novembro a edição 2024 da  formação CONTROLO DE ALTERAÇÕES, conduzida por  Sara Cunha , CHC & GEM Quality Business Partner, da Sanofi Uma excelente formação , apresentada com muita clareza e casos práticos que permitem pôr em prática os...

Posted on 11.11.2024 by MedTech Europe MedTech Europe envisions a future where healthcare systems are environmentally and financially sustainable, equitable and resilient to future crises. In light of the European Commission’s announced Sustainable Prosperity and...

Recentrly published ICH E6 (R3) Annex 2 draft, now released for public consultation! For the purposes of Annex 2, decentralised elements in a clinical trial are those trial-related  activities conducted outside the investigator’s location (e.g., trial visit is...

Consumers are exposed to chemicals present in cosmetics. Any cosmetic product sold on the EU market must comply with the rules set up by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (the Cosmetic...

This questionnaire was prepared in accordance with the request of MDCG, published in the Medical Device Coordination Group (MDCG) position paper in August 2022, for notified bodies to develop common guidance for manufacturers to assist them in the application phase...

In September 2024, the European Union (EU) published Commission Delegated Regulation (EU) 2024/2564 of June 19, 2024 to revise Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, consolidated version to...

Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the...

Independent experts present the first draft of the General-Purpose AI Code of Practice, which will be discussed with around 1000 stakeholders next week. The AI Office is facilitating relevant AI Act understanding with dedicated questions and answers for stakeholders....

Decorreu  a edição número 14 da formação sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO de DISPOSITIVOS MÉDICOS; uma formação dinâmica, super interessante donde foram abordados os temas de forma prática e concisa e adaptadas às várias realidades . Uma formação essencial para...

Decorreu mais uma edição do MASTER COURSE Autorização, publicidade e comercialização de SUPLEMENTOS ALIMENTARES, Uma visão exaustiva , atual e prática dos conhecimentos imprescindíveis para fabricar, introduzir e manter-se no Mercado de Suplementos Alimentares Uma...

Portaria n.º 293/2024/1, de 15 de novembro Sumário: Procede à definição dos países de referência a considerar em 2025, para a autorização dos preços dos novos medicamentos e para efeitos de revisão anual de preços dos medicamentos adquiridos pelos estabelecimentos e...

The proposals in this consultation document are just one element of the government’s focus on patient safety. Since the current regulatory framework was introduced, medical technology has advanced significantly, for instance the growth in the use of advanced...

Ontem, tivemos o prazer de realizar uma nova edição da formação exclusiva da FORMIVENTOS  sobre o PROMOTIONAL REVIEW de Medicamentos :  COMPLIANCE & BEST PRACTICES, com uma visão global da legislação ,  para consolidar e rever casos específicos da revisão de...

  Obrigado a todos os que participaram o dia 12 de novembro na formação DISPOSITIVOS MÉDICOS :  bajo o lema O MUST-KNOW REGULAMENTAR PARA UM OPERADOR EUROPEU A  formação , conduzida por José Malta, RA/QA & Compliance Manager, da  ALL4COMPLIANCE – Freelance...

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The...

Obrigado a todos os que participaram os dias 5 e 6 de novembro na formação  BOAS PRÁTICAS de FARMACOVIGILÂNCIA, bajo o lema "Gestão do sistema de farmacovigilância, Qualidade e Riscos, e estado de inspection-readiness " Uma formação muito esclarecedora, conduzida por...

Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards...

Teve lugar nos dias 5 e 6 de novembro mais uma edição da formação exclusiva da Formiventos : GDP Nível 2 : BOAS PRÁTICAS DE DISTRIBUIÇÃO Nível Avançado Formiventos é reconhecida por garantir  experiências formativas exclusivas e de alta qualidade,  e por contar com...

  The European Commission adopted the 2025 work programme of the European Innovation Council. It opens funding opportunities worth over €1.4 billion for strategic technologies and scaling up companies. The European Innovation Council and SMEs Executive Agency...

This expert review report supports the delivery of the BDSG workplan 2023 to 2025 (HMA/EMA joint Big Data Steering Group, 2023). To further progress and strengthen the work already done to enable the use and establish the value of different types of RWD to support...

10th notified bodies survey on certifications and applications (MDR/IVDR) Survey results of the 10th NB survey with data status 30 June 2024 (small and medium dataset) 30 October 2024

Decorreu no 30 de outubro uma nova  edição da formação : VALIDAÇÃO de TRANSPORTE em ambiente BPD , bakop o lema  " Elaboração, revisão e aprovação do protocolo de validação do transporte e respetivo relatório de validação. Uma  formação prática, que inclui análise de...

The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets...

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information...

The European Parliament has published the adopted text of the resolution for the "Urgent need to revise the medical devices regulation" The resolution aims to ensure that regulations adapt to evolving medical needs and innovation while maintaining patient safety. The...

This document has been prepared by the IMDRF Adverse Event Terminology Working Group (AET WG), charged with developing a harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs). Since GHTF SG2/N54 (Medical...

  A revisão do Regulamento Europeu relativo a alterações aos termos da Autorização de Introdução no Mercado (AIM) entrará em vigor a 1 janeiro de 2025. Destaca-se com maior impacto, a alteração nos procedimentos das alterações IA e dos procedimentos de partilha...

The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been amended by Regulation (EU) 2023/607. In particular, the transitional period has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028, depending on the risk...

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously and...

EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy, which was developed to cover the period 2021 to 2025...

The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. In...

This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact assessment, monitoring and other related services in relation to health and food policies. • The information and views...

This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on...

publicado no site www.infarmed.pt. 7 Outubro  O Infarmed, enquanto membro da Rede Europeia de Regulação de Medicamentos, integra a iniciativa da Agência Europeia de Medicamentos (EMA na sigla em inglês) e dos Chefes das Agências de Medicamentos (HMA na sigla em...

Foi publicada, na área Consultas Públicas do site do INFARMED, I.P., a abertura de nova consulta pública no âmbito da implementação do Regulamento do Parlamento Europeu e do Conselho da União Europeia relativo à Avaliação de Tecnologias de Saúde (ATS), nomeadamente...

The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their...

This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems,  electronic records, and electronic signatures in clinical...

The utilisation of artificial intelligence (AI) is an important part of the digital transformation. Such systems are often developed through the process of machine learning (ML) where models are trained from data, with or without human input. However, as these models...

This document responds to requests by the World Health Assembly to the Director-General in resolution WHA75.8 (2022) on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination to identify...

Today (25-September) the Medical Device Coordination Group (MDCG) has published "MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746" According to Regulation...

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims...

Dispõe sobre os procedimentos para a transferência de titularidade de registro de produtos sujeitos à vigilância sanitária, transferência global de responsabilidade sobre ensaio clínico e atualização de dados cadastrais relativos ao funcionamento e certificação de...

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff September...

Document issued on September 23, 2024.   FDA DRAFT GUIDANCE on Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory MedicalEquipment – Standards SpecificInformation for the Accreditation Scheme for...

TEAM NB: Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 "Improving implementation of the European CE certification of medical devices through the harmonisation of Notified Bodies" Version: 5.0 Date: September 16th 2024 Key...

  This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic SEPTEMBER 2024 This Guide provides technical recommendations to sponsors4 for the submission of animal and...

INTRODUCTION This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at...

This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs)...