CORE-MD expert meeting the Clinical Investigation and Evaluation Working Group
On 7th November, the experts involved in CORE-MD took part in the workshop organised by the EU WG Clinical Investigation and Evaluation (CIE). The aim of the meeting was to present to the European regulators the initial results of CORE-MD and reflect on the current challenges derived from the implementation of the Medical Devices Regulation. […]
New MDCG guidance document
Where the manufacturer of a device is not established in a Member State, the device may onlybe placed on the Union marketif the manufacturer designates a sole authorised representative. The term ‘device’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical […]
CORE-MD at ISAR conference
Within the CORE-MD Consortium, Drs Lotje A. Hoogervorst,MD, PhD student is working with Dr Perla J. Marang-van de Mheen on aggregating insights from registries, big data and clinical experience (Task 3.1). During the last International Society of Arthroplasty Registry conference in Dublin, Drs. Hoogervorst, gave two lectures on “Quality of European orthopaedic registries for the regulatory evaluation of medical […]
CORE-MD TV session at ESC Congress
In the framework of the annual congress of the European Society of Cardiology (Barcelona, Friday 26 – Monday 29 August), a dedicated session on CORE-MD was organised. Three active partners in CORE-MD discussed about clinical trials for medical device and presented its benefits for regulators. Prof. Piotr Szymanski (Chairman of the EU Regulatory Affairs Committee […]
Biomed Alliance’s survey on availability of medical devices
Further to its June press release, the Biomed Alliance issued a survey to assess whether clinicians in different fields are already experiencing issues around the availability of certain medical devices, which devices are affected and whether they expect to experience any issues in the future. Reports from clinicians, the European Commission and manufacturers have shown […]
Call for application to designate European Reference Laboratories
According to Article 100 of Regulation (EU) 2017/746, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs). The EURLs have two main categories of tasks: advisory ones and those related to market access of class D devices. For market access of class D devices, the EURLs will verify […]
Experts’ views and analysis on the challenges of IVDR
In the framework of the BioMed Alliance In Vitro Diagnostics (IVD) Task Force, experts on in vitro diagnostic medical devices provided their analysis on the challenges of IVDR. Several experts are also CORE-MD partners. With the implementation of Regulation (European Union [EU]) 2017/746 on in vitro diagnostic medical devices (IVDR), from May 26, 2022, onwards, […]
New publication of Harmonised standards under the medical devices Regulations
The European Commission issued its Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices. According to the Medical Device Regulation, devices that are in conformity with the relevant harmonised standards, or the relevant parts of […]
Fill out & Promote our CORE-MD Survey on educational needs in regulatory affairs
A new survey was launched by CORE-MD partners, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory affairs. The survey takes around 10-15 minutes to complete and is open until 10th June. This survey will help to assess what sort of knowledge clinicians have on regulatory affairs (particularly related to […]
Medical Device Regulation in the focus of the CORE-MD annual meeting
Members of the CORE-MD consortium met recently for the first time in person. More than 50 investigators gathered at the University of Leiden and online for an intensive overview of progress with multiple tasks, all coordinated by the European Society of Cardiology in close partnership with European Federation of National Associations of Orthopaedics and Traumatology […]
