National MDR & IVDR Conference 2022: IBSA Farmaceutici – a successful case study in medical device certification

A company that has always been at the forefront of innovation, not only for its research and development, but also for its ability to adopt extremely rigorous industrial processes, capable of ensuring the highest quality and safety of its products: it is on this front that IBSA Farmaceutici has distinguished itself at the National MDR & IVDR Conference 2022, a leading international event organised to take stock of the new MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) issued by the European Union.

Held in Bern (Switzerland) on October 19, the conference organised by Swiss Medtech was an opportunity for representatives of Regulatory Authorities and industry associations to discuss the regulatory aspects of the development, export, import and distribution of medical devices. In this context, IBSA Farmaceutici was invited to tell its own experience, as a virtuous example of application of the new Regulation (EU) 2017/745: a truly successful case study in the context of the recertification of pre-filled syringes, led by the Regulatory Affairs department. To achieve this excellent result, IBSA Farmaceutici has indeed fielded an extremely well-prepared team, which – under the direction of Antonella Mamoli, Senior Regulatory Affairs Manager – carefully followed all the necessary steps.

Ensuring high standards, so that the products available to patients are in compliance with all the required regulatory requirements, is only possible thanks to the support and hard work of a team of specialised and highly qualified people”, said Antonella Mamoli, Senior Regulatory Affairs Manager. “Being internationally recognised as a best case is highly rewarding, not only for me and my team, but for the whole company and the various Functions with which we collaborate in close synergy.

The recertification process required an exhaustive study of the subject and a multi-stage development. The first step was the planning of a series of training sessions focused on the new Regulation by the Regulatory team. Over the years – from 2017 until the certification, obtained in 2022 – a constant collection of materials and an update of the documents to be submitted to the final check have also been carried out. Finally, last June, there was the validation of the results presented and the obtainment of the recertification.

Started in 2017, the recertification process was long and complex, but in the end, it rewarded us; we are therefore proud to have brought our experience to such an important context as the National MDR & IVDR Conference”, stated Alessia Gatti, Senior Regulatory Affairs Specialist at IBSA Farmaceutici. “The context in which we operate in order to obtain certifications is not simple, but this success proves that it is possible to achieve the goal, in compliance with current regulations”.

We are very proud of the success achieved. The commitment and dedication of the entire team have been critical in reaching this important milestone”, commented Lorenzo Bracchi, Regulatory Affairs Coordinator at IBSA Farmaceutici. “The invitation to the Bern conference establishes our achievement as a virtuous example to follow”.

IBSA Farmaceutici ensures impeccable quality standards in every area of ​​its activity: from research to production, from packaging to logistics, from general to administrative services, the Company is constantly committed to guaranteeing the highest levels of attention, accuracy and rigor in control procedures and certifications. And this is then reflected in the authorisations issued by the Regulatory Authorities, as in the case of the inspection by the Food and Drug Administration (FDA) – the Authority that approves the marketing of drugs and medical devices in the United States – which in 2022 confirmed the authorisation for the sale of a hyaluronic acid-based medical device in a vial-syringe for intra-articular use, produced in the facility in Lodi and exported by IBSA to the US market.

A commitment IBSA nurtures every day, with the aim of offering value and quality assurance to its patients.