NOTICIAS

Purpose and Scope The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745...

EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms...

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the nation’s food supply, cosmetics,...

This guidance specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action. The  ICHM13A Guideline is the first guideline in a foreseen ICH series describing the scientific and...

The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in...

Electronic product information (ePI) for European Union (EU) medicines will benefit patients and healthcare professionals (HCPs) by providing up-to-date information on safe and effective use at the point of need. It contributes to the objectives of the European...

Publicado no site  INFARMED   O Infarmed promove e incentiva o uso de embalagens multilingue atendendo à necessidade de garantir o acesso pelos doentes e profissionais de saúde aos medicamentos. Assim o Infarmed convida à consulta das recomendações constantes das...

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) entered into force on 11 January 2022 and will apply from 12 January 2025. In the preparatory phase for the implementation of the HTAR (January 2022 – January 2025), this webpage aims at informing...

Publicado no site infarmed   Circular Informativa N.º 106/CD/100.20.200 Data: 13/12/2024 A 1 janeiro de 2025 entrará em vigor a revisão do Regulamento Europeu relativo a alterações aos termos das autorizações de introdução no mercado (AIM) - Regulamento Delegado...

Q&A on practical aspects related to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a MDR and IVDR as introduced by Regulation (EU) 2024/1860 of 13 June 2024 amending...

Decorreu no 6 de dezembro uma nova edição da formação Qualificação de FORNECEDORES ,Clientes e Entidades Subcontratadas, conduzida por Teresa Cruz, da MTA Pharma A formação ofereceu uma análise pormenorizada do processo de qualificação de fornecedores e clientes, para...

.-.-  “Formação muito prática e completa . A Rita apresentou os temas de forma muito clara , esclarecendo todas as dúvidas e com exemplos práticos . Sem dúvida uma mais valia para a consolidação de conhecimentos sobre a formulação e análise de suplementos...

In the light of the anticipated go-live of most European database on medical devices (EUDAMED) modules in 2025, MedTech Europe summarises in a position paper the industry viewpoints on the smooth transition to the mandatory use of the European database for medical...

Obrigado a todos os que participaram na última edição da formação BOAS PRÁTICAS DE DISTRIBUIÇÃO DE MEDICAMENTOS, os dias 3 e 4 de dezembro . Ao longo das 14 horas de formação dinamizadas pela formadora Sónia Rei, foram analisados em pormenor e todos os pontos...

"Formação muito útil , com exemplos práticos . Formadora muito acessível e disposta a tirar dúvidas . Evento bem organizado. “ GENIBET   No passado dia 5 de dezembro  decorreu em Lisboa a formação  AUDITORIA INTERNA, nível avançado desenhada com o objetivo de...

“Formação importante na consolidação de conhecimentos e esclarecimento de questões de ordem prática e do dia-a-dia. “ LABORATÓRIOS AZEVEDOS Decorreu mais uma edição da formação  "Como implementar, manter e rever o Sistema CAPA " O workshop apresentou os conceitos e...

This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third...

FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to...

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...