MDR: Devices Based on Substances

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…

The Crucial Role of Clinical Trials

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…

Discover our ready-to-market line

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,…

Further amendment to the lists of harmonized standards with presumption of conformity with European medical device regulations

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…

Vitafoods 2023 – Gruppo FarmaImpresa

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…

MDR extension has officially entered into force

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 of the transition period has been accepted!

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…

MDR: Extension of the transition period?

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…

MDR News from the EU: the CAMD

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…