As it has done every year for nearly 30 years, ISPE’s magazine, Pharmaceutical Engineering®, has just announced the winner of the Roger F. Sherwood Award, which recognizes the best article of the year for quality and excellence in content for the pharmaceutical industry.
For this new edition, no less than 35 articles were submitted to the jury chaired by Michelle GONZALEZ in 2021. The prize, awarded to the article “Management of UDI components of medial devices in the European Union” co-authored by twelve authors including Christophe Devins, co-founder and CEO of Ackomas, will be presented during the annual ISPE congress in Orlando, Florida, on November 1st.
The award-winning paper highlights the importance of unit identification for medical devices and the new traceability requirements of regulatory standards. The article discusses Eudamed, the European Union’s database, and the components of the UDI system, such as the basic UDI-DI for identifying product groups, the UDI-DI for specific devices, and the UDI-PI for the entire production process of the device. The article also sheds light on serialization and the obligations placed on medical device manufacturers.
“We are aware of the complexity of the actions that need to be taken to comply with MDR and IVDR regulations. These regulations involve all levels of the company, from sales to information technology, from manufacturing to QA/QC,” said Christophe Devins. “But beyond the challenges this represents, UDI not only brings a common language to the entire supply chain, but above all a considerable improvement in the safety of medical devices for end users and patients. This is now a global development and stakeholders can no longer ignore regulatory changes.”
Authors
- Laurence AZOULAY – Category Manager for Healthcare Industry, GS1 France,
- Marie COULON – PharmD, Regulatory Affairs Project Manager, Povepharm SAS
- Christophe DEVINS – Founder & CEO, Ackomas
- Bernard DURAND – Computer Sciences Engineer, Courbon Software
- Etienne GARNIER – Packaging Expert, Laboratories Théa
- Amel GUERRISA MARCHAND – Validation Expert, SEPTODONT
- Ye-Lynne LEE – Consultant
- Valérie MARCHAND – Communication, GS1 France
- Patrick MAZAUD – Hospital Pharmacist, Euro-Pharmat member
- Brigitte NAFTALIN – Regulatory Affairs Manager & Content Strategist, ADENTS HTI International
- Michel TASCHAS – Consulting Validation & Services Director, PROGMP SAS
- Nadim WARDÉ – Data Management Consultant
Themes
