MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028 The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation. However, because of concerns…
From a scientific perspective, Clinical Trials refer to the systematic study method conducted on humans (patients or healthy volunteers) with the purpose of verifying the effects of a product and/or identifying any adverse reactions, studying its absorption, distribution, metabolism, and excretion to establish its efficacy and tolerability. Clinical Trials must therefore confirm or refute the…
Requirements for Clinical Trials: the Ministerial Decree of March 20, 2023 by the Ministry of Health The Decree of March 20, 2023, concerning the requirements for facilities conducting clinical trials, is a significant regulation for the healthcare sector. It was published in the Official Gazette on June 14, 2023, and issued by the Ministry of…
European Commission guidelines for the optimal drafting of the summary of the clinical investigation report under the MDR The European Commission recently published the “Commission Guidelines on the Content and Structure of the Summary of the Clinical Investigation Report” (2023/C 163/06). These guidelines provide guidance on how to prepare the summary of the clinical investigation…
In this article we are going to analyze the questions and answers regarding the new European Regulation 2017/745 or MDR (Medical Device Regulation). Recall that we are among the first Italian companies to have obtained MDR certifications for some of our medical devices. How are economic operators regulated in the new MDR regulation? In…
Gruppo FarmaImpresa is among the first Italian companies to obtain MDR certifications for some of its substance-based medical devices As a reminder, the new Regulation (EU) 2017/745 or MDR (Medical Device Regulation) is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place…
The new Regulation (EU) 2017/745 or MDR is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place a medical device on the European market. The new Regulation complements and replaces the previous Directives 90/385/EEC and 93/42/EEC, providing more stringent requirements and measures…
Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.…
EPSCO meeting: commission discussed the future of medical devices With the adoption of the European Medical Device Regulation (MDR) 2017/745, the regulation for medical devices has changed dramatically. The main goal of the MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level…
CAMD announces efforts to avoid plausible future shortage of essential medical devices On October 20-21, 2022, the 51st meeting of the European Union Competent Authorities for Medical Devices (CAMD) was held in Prague under the Czech Presidency of the Council of the European Union. As a reminder, with the adoption of the European Medical Device…