MDR-Certified Vaginal Suppository: Women’s Health Milestone

Gruppo FarmaImpresa at the Top of European Quality: Maximum Safety for Gynecologic Well-Being The EU Regulation 2017/745 (MDR) is Europe’s most stringent framework for manufacturing and marketing medical devices. It raises the bar on safety, quality, and traceability, introducing far stricter requirements than previous directives. For Gruppo FarmaImpresa, obtaining MDR certification for the Class IIb…

Medical Device Regulation: Toward Efficiency and Innovation

Navigating the Future of Medical Devices: A Deep Dive into the European Commission’s MDR Revision and Industry Proposals for a More Efficient and Innovative Landscape The European Commission has officially announced the launch of the Medical Device Regulation (MDR) revision, a welcome development for the industry. This initiative, communicated by European Commissioner for Health, Olivér…

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,…

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…

Gruppo FarmaImpresa receives first MDR certifications

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…