Étiqueté : IVD Medical Devices
EMA recently published on its website a new page dedicated to Personalised medicine in oncology giving more information on its role in this area. The European Medicines Agency (EMA) offers developers of personalised medicines in...
The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746. The EURLs have two main categories of tasks: advisory ones and...
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation...
On 17 October 2025, the European Commission adopted an implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment Regulation. Read the e-News...
In this webinar, Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups will explain the process for joint clinical assessments and joint scientific consultations for high-risk medical devices...
The sixteenth meeting of the Member State Coordination Group on Health Technology Assessment set up by Regulation (EU) 2021/2282 was held on 23 October 2025 in Brussels. The meeting covered the following points: 1) Preparation...
Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is...
The document shows the results of the 14 th notified bodies survey conducted at the beginning of March 2025 with requested data from notified bodies designated under Medical Devices Regulation and/or In Vitro Diagnostic Medical...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure,...
This guidance aims to describe the obligations of app platform providers and their respective responsibilities under the Medical Devices Regulation/In Vitre Diagnostic medical devices Regulation as well as the Digital Services Act, which introduces requirements...