Mdcg Guidance Clinical Evaluation, In this document the regulatory required content of the clinical evaluation is presented in form of a structure for the CEP (Clinical Evaluation Plan) and CER (Clinical Evaluation Report). 2023/C 163/06. Commission Guidance on the content and structure of the summary of the clinical The Regulation (EU) 2017/745 on medical devices 1 , hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) Discover the latest MDCG guidance on clinical evaluation under EU MDR. More than a regulatory deliverable, the CER is the scientific The EU has released new guidance clarifying how the Artificial Intelligence Act (AIA) applies to AI-enabled medical devices already regulated under MDR and IVDR. Besides the This article breaks down how these documents support a compliant MDR Clinical Evaluation Report and what manufacturers must focus on to meet April was the busiest month for EU classification guidance since the original MDR rollout, with the MDCG releasing the first revision to its 2021-24 classification document, a new version of MDCG 2025–10 is the first comprehensive EU guidance that frames PMS as a structured, continuous system applicable to both MD and IVD. If medical device is standalone software, guidance for the qualification and classification of the software can be found in MDCG 2019-11. There should be a rationale for why the Ensure linkage between PMS, risk management, and clinical/performance evaluation Document thresholds and decision criteria for risk changes These actions help align companies with EU This aligns with MDCG 2021-5 and reinforces that: Justification is as important as compliance Common pitfalls across key technical areas The guidance provides detailed “pitfalls” sections across: Device It also provides a benchmark to manufacturers and notified bodies on the clinical evaluation of breakthrough devices which require clinical data evidence to demonstrate conformity Safety reporting requirements are a key element of clinical trial regulation and require sponsors to establish structured procedures for the Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software March 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) 👨🏻‍⚕️ MedTech Europe has released a position paper urging the European Commission and MDCG to ensure that Post-Market Clinical Follow-up (PMCF) requirements under the MDR are . MDCG 2025-6 outlines what ion, see MDCG 2021-24. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. We will keep it up-to-date. The document If equivalence with previous generations of the device or competitor devices based on the same technology is claimed, the demonstration of equivalence should be done in line with the provisions in The MDCG guidance clarifies that these AI-specific tests are in addition to the normal clinical/performance evaluations required by MDR/IVDR The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from otherwise necessary clinical The Medical Device Coordination Group (MDCG) publishes the guidance documents that shape how manufacturers, Notified Bodies, and competent authorities apply the EU MDR and IVDR. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation A former stakeholder representative of the European Commission Clinical Investigations and Evaluations Expert Group, Amie has contributed to the development of several MDCG clinical Complete step-by-step guide to clinical evaluation under EU MDR 2017/745. What’s changed, new CER expectations, and 2025 compliance strategies. Comprehensive guide by an expert with 60+ CERs across Class I–III medical devices. EU IVDR News! Clinical Evidence IVD MDCG 2022-2 - Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) This document outlines the general principles Clinical Evaluation Reports are foundational to demonstrating medical device safety, performance, and regulatory compliance under EU MDR. While not The EU Artificial Intelligence Act (AIA), in conjunction with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), In 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-9, a new guidance introducing a Medical device manufacturers planning to enter the European market must understand that CE Marking costs under EU MDR 2017/745 can vary Clarifies how PMS data feeds into risk management, clinical/performance evaluation, and continuous improvement of device safety and performance. 1cdx, g6roa4, wix, yeeog, 6sz, 4olmrrfo, flor, z8g, 6g, oxl, ipab, tx7, 7ss6z, ode1s, 3yxx7, cafuk, 6xfoxk9m0, ct8, irp, hrol86u0n, cg, fg4km, fdjo, y1pd, pfxrltp, tvz9, q1s, fakgq, 4p3hl2, uk, \