Latest Regulatory Updates on Medical Devices: What You Need to Know to Stay Compliant The medical devices sector is constantly evolving, driven by both technological advancements and the regulatory complexity governing the market. Adding to the complexity is the fact that medical devices are sometimes subject to intersecting regulations, such as Regulation (EU) 2017/745 (MDR),…
Visit Us at CPhI Worldwide Milano – Stand 14D69 We are excited to announce that from October 8 to 10, we will be at CPhI Milano at Fiera Milano, Hall 14, Stand 14D69. We look forward to welcoming you to our stand and showing you what we have in store. đź“Ť Where to Find…
MDR: Innovations and Implications for Medical Devices Based on Substances Regulation (EU) 2017/745 has introduced significant innovations in the field of medical devices, particularly those composed of substances. However, the distinction between these and medicines can be blurred, leading to lengthy and complex discussions. The European Commission’s MDCG 2022-5 guide aims to clarify these contentious…
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…
Gruppo Farmaimpresa’s ready-to-market products: the PJPharma line We present an overview of some of the products in our ready-to-market PJPHARMA line; remember that they can be made, also, in private label. Each is carefully designed to provide effective and safe solutions for wellness and health. We are excited to introduce our line to future distributors,…
The European Commission has published in the Official Journal of the European Communities (OJ) the second amendments to the lists of harmonized standards. The harmonized standards listed in the OJ provide a presumption of conformity with the relevant requirements of the Medical Device Regulation ( MDR ) and the In Vitro Diagnostic Medical Device Regulation…
We are excited to announce our participation in Vitafoods 2023, which will be held at Geneva Palexpo (Geneva, Switzerland) on May 9-10-11, 2023. Hall:6, Booth: L250-1 (Italian Pavillion). The event will be an opportunity to establish new business relationships and consolidate existing ones by offering clients customized solutions that meet their specific needs. We are…
The extension of the European Regulation 2017/745 (MDR) was published in the Official Journal With the publication in the Official Journal of the EU (number L080), the extension of the European Regulation 2017/745 (MDR) came into force. The amendment now applies to the entire Union, as stated in Article 1 of the MDR and IVDR.…
MDR extension: accepted proposal to amend European Regulation 2017/745 (MDR) The proposal to amend European Regulation 2017/745 MDR and European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting, has been approved. The main objective of European Regulation 2017/745 MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory…
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…