Extension of MDD Certificate for Our Medical Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) Based on Alginates The MDR regulation, effective from May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Devices Directive (MDD) until December 31, 2027, for…
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…
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…
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…
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…
With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulation for medical devices and in vitro medical devices has changed dramatically. The main objectives of the 2017/745 European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable…
Economic players, new definitions, and the roles players can play in the medical device market With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR regulation, the figures of traders were,…