NOTICIAS

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The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well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

This document provides guiding principles on the use of general-purpose large language models (LLM) in regulatory science and for regulatory activities and provides high-level recommendations to regulatory authorities to facilitate the safe, responsible and effective...

The IMDRF Management Committee has today uploaded "IMDRF Document Implementation Report" This document provides a report on the status of implementation of all IMDRF technical documents as self-identified by IMDRF members as of the date of publication

FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time...

This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also...

The health and medicine sector are increasingly digitized, a trend that will accelerate with more widespread adoption of artificial intelligence, wearables and internet of things-based healthcare. Yet, this digital transformation carries notable cybersecurity threats....

ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic...

Devices that according to the Medical Devices regulations are not to be registered in the UDI/Devices module but are to be referenced in a Vigilance report can be registered in EUDAMED as NRDs. For the Vigilance module, NRDs are Old Devices or Custom-made Devices....

The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements. These requirements include; Medical devices – Quality management systems – Requirements for...

The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors  representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the...

Version 3.9 brings significant changes to the implementation of the Master UDI, it is essential that you keep up to date to ensure compliance with European regulations

Encontram-se disponibilizados no site do Infarmed os relatórios de monitorização do mercado de medicamentos do mercado ambulatório, hospitalar e locais de venda livre de medicamentos não sujeitos a receita médica (LVMNSRM), todos referentes ao 1.º semestre de 2024....

  ️ Important news for medical device manufacturers in the European Union!   ➡️ The Commission has renewed the designation of the UDI issuing bodies for a period of five years, from June 27, 2024 to June 27, 2029. ➡️ These...

📊 A total of 40 studies were conducted between February 2023 and February 2024. 🌐 The DARWIN EU network expanded from 10 to 20 data partners since 2023, allowing access to data from almost 130 million patients from 13 European countries - in full...

The AI Act, the world’s first comprehensive artificial intelligence law, enters into force today. European citizens and businesses can now safely and confidently seize the opportunities of secure and trustworthy AI which plays by clear rules: 🔴 Unacceptable...

The EU regulatory system for medical devices outlined in the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) represents an important evolution over the previous legislation, seeking to ensure appropriate levels of protection of public health...

FDA issued a draft guidance that provides biologic product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to biosimilar and interchangeable biosimilar products:...

O período de transição do Regulamento Europeu de Ensaios Clínicos n.º 536/2014 de 16 de abril(CTR) termina a 30 de janeiro de 2025. Desta forma, os promotores que ainda tenham ensaios clínicos autorizados, ao abrigo da Diretiva nº 2001/20/CE de 4 de abril e que esteja...

WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks. Laboratories are essential components of health systems, critical for patient diagnosis and rapid clinical care, disease surveillance, pathogen...

This document provides guidance to industry and FDA staff on the purpose and content of a userelated risk analysis2(URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product3 19 development and to support...

On 12-July "Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and...

Q&A on practical aspects related to the implementation of the extended  transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of...

The EU-X-CT Cross-Border Clinical Trials Initiative, co-led by the European Forum for Good Clinical Practice (EFGCP) and EFPIA, is dedicated to enhancing access to cross-border clinical trials in Europe. This initiative focuses on identifying barriers to participation...

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under...