Notícias
Instituto Pedro Nunes organiza evento sobre conformidade regulatória e avaliação clínica de dispositivos médicos
O Instituto Pedro Nunes (IPN) e a Nova Medical School (NMS) estabeleceram uma parceria para fortalecer a capacidade das instituições em atrair novos parceiros ou clientes para os seus serviços na área dos dispositivos médicos.
Important Update for IVD Manufacturers: EU MDR/IVDR Deadlines Extended!
Attention IVD manufacturers! There's important news regarding EU MDR/IVDR compliance deadlines.
Regulatory News for Medical Devices: Regulation (EU) 2024/1860
Attention medical device manufacturers! The Medical Devices Regulatory — support unit (MDRu) informs you about the publication of the new Regulation (EU) 2024/1860, which brings important changes to the sector.
Important Update: MDCG 2020-16 Rev.3 Guidance on IVD Classification Rules
The Medical Device Coordination Group (MDCG) has released an updated version of the Guidance on Classification Rules for in vitro Diagnostic Medical Devices (IVDs) under Regulation (EU) 2017/746.
Medical Devices Update: New Guidance for Medical Device Standards in the EU
The MDCG has released a revised document (MDCG 2021-5 Rev. 1) offering guidance on using standards to comply with EU medical device regulations.
Medical Devices Update: MDCG 2024-10
The Medical Device Coordination Group (MDCG) published a new document on June 25th titled "MDCG 2024-10 "Clinical evaluation of orphan medical devices".
The FDA released its final guidance document: "Laboratory Developed Tests (LDTs): Small Entity Compliance Guide"
This guide helps small entities navigate the new regulatory landscape for LDTs, as outlined in the recent LDT Final Rule.
EIT Health Regulatory Pathways to Market Bootcamp
Attention healthcare innovators! Ready to spearhead change in the healthcare sector? The EIT Health Regulatory Pathways to Market Bootcamp is your ticket to success!
Medical Devices Update: EU Regulations and Standards for Safe Medical Devices
The European market prioritizes the safety and efficacy of medical devices. The MDR (EU Regulation 2017/745) governs the entire lifecycle of these devices in Europe, ensuring they function as intended and minimize risks.
The US FDA, Health Canada, and UK MHRA released a new document today
This builds on the 2021 Good Machine Learning Practice (GMLP) principles, providing additional considerations for developers and regulators on ensuring transparency in AI-powered medical devices.
MDRU attended the Hospitalar 2024, in Brazil, a renowned Hospitalar trade fair
We are dedicated to advancing the medical device and IVD sector through comprehensive regulatory support.
Medical Devices Update: Council adopts new measures to help prevent shortages
The European Council recently updated regulations on medical devices to address potential shortages and improve transparency.
EU gives final green light to the first worldwide rules on AI
The EU Council has approved the Artificial Intelligence (AI) Act, establishing the world’s first comprehensive AI rules.
A quick look at the webinar ‘Mastering the Clinical Evaluation of Medical Devices’, which took place last week
Sandra Balseiro and Celeste Oliveira, from MDRu, provided an in-depth understanding of the regulatory requirements for clinical evaluation.
Exciting News! The new version of EUDAMED 3.8.0 has been deployed!
For all the details on what's new and improved in this release, check out the full release note document available at the EUDAMED Information Centre - EUDAMED (playground).
A quick look back at our recent webinar "Software as a Medical Device and the Regulatory Implications of AI".
Sandra Balseiro delved into European Regulation for Software as a Medical Device, providing strategic insights to streamline the regulatory approval process.
The International Medical Device Regulators Forum (IMDRF) has just released a new final document!
This latest document, IMDRF/GRRP WG/N71, is part of a series aimed at streamlining the regulatory approval process for medical devices.
Medical Devices Update: New Guidelines for Medical Device Labeling
The International Medical Device Regulators Forum (IMDRF) has released a new document outlining the principles of labeling for medical devices, including those for in-vitro diagnostics (IVDs).
News from the European Commission
Dive into the details of Scientific Opinion No. 15, a comprehensive report by the European Commission's Group of Chief Scientific Advisors (GCSA).
Medical Devices Update - MDCG 2024-4
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746, April 2024.
Medical Devices Update
Discover fresh insights from the latest study on the implementation of Article 17 of Regulation (EU) 2017/745 concerning medical devices in the EU market.
Sandra Balseiro was a speaker on the webinar "Development of the Researcher's Brochure", organized by AICIB
Sandra shared valuable insights on the nuances of the Investigator's Brochure for In Vitro Diagnostic Medical Devices, offering practical guidance on navigating regulatory requirements and ensuring compliance.
Sandra Balseiro and João Quintas participated on the Webinar: Understanding Medical Devices Regulation
This event was an opportunity to deepen knowledge of medical device regulation.
Are you a medical device manufacturer in Portugal? This is important news for you!
The recent publication of Decree-Law 29/2024 transposes Regulation (EU) 2017/745 on medical devices into Portuguese law and includes the following topics:
FDA paper alert! Dive into the future of healthcare with the FDA's latest paper on "Artificial Intelligence & Medical Products."
Artificial intelligence has the potential to transform medical product development, enhancing patient care, and empowering healthcare professionals.
The European Parliament has given the green light to the EU AI Act
But what does this mean? The regulation awaits the final review and adoption before the legislative session ends, with Council endorsement still to come.
MDCG NEWS!
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
EU MDR/IVDR Update
The Medical Devices Harmonised Standards have been updated with the two implementing decisions published by the European Commission.
Did you know?
The U.S. Food and Drug Administration (FDA) is issuing a critical warning regarding the use of smartwatches or smart rings to measure blood glucose levels without piercing the skin.
Important Update in EU Medical Device Regulation
MDCG 2024-1-4: Guidance on the Vigilance System for CE-marked devices DSVG 04: Breast Implants. January 2024.
Important Update in EU Medical Device Regulation
MDCG 2024-1-3: Guidance on the Vigilance System for CE-marked Devices (DSVG) 03: Cardiac Implantable Electronic Devices (CIEDs). January 2024.
IPN LAS has achieved ISO 13485 certification
ISO 13485 certification demonstrates our adherence to the highest standards of quality management systems specifically designed for manufacturers and suppliers of medical devices.
Important Update in EU Medical Device Regulation
MDCG 2024-1-2 Guidance on the Vigilance System for CE-marked Devices (DSVG) 02 Coronary Stents and associated delivery systems. January 2024.
US FDA News!! (FDA - Quality Management System Regulation)
The FDA has published (31-Jan) the "Quality Management System Regulation final rule"
We participated in the presentation of TEF-Health and DigiHealthPT projects
Through these projects, our team specializes in assisting SMEs and start-ups with regulatory compliance and supporting the certification of medical devices, IVDs, and medical software.
Important Update in EU Medical Device Regulation
In January 2024, the medical device community is greeted with updated guidance from the Medical Device Coordination Group (MDCG).