Rapporto ISTISAN 21/9 -Identification and traceability of medical devices: role and responsibilities of economic operators and application tools for the Regulation (EU) 2017/745. Sergio Sbrenni, Marcella Marletta, Daniela Di Sciacca, Antonio Conduce - ISS (EN)

Istituto Superiore di Sanità
Identification and traceability of medical devices: role and responsibilities of economic operators and application tools for the Regulation (EU) 2017/745.
Sergio Sbrenni, Marcella Marletta, Daniela Di Sciacca, Antonio Conduce
2021, ii, 98 p. Rapporti ISTISAN 21/9 (in Italian)

An inadequate medical device management system may represent a serious risk in patients’ or end-users’ health. A medical device must, at any time and for any given reason, be identifiable and traceable both in the supply chain and on the market. This requirement becomes critical in the event of counterfeit or potentially harmful products. The new Regulation (EU) 2017/745 of the European Parliament and of the Council modifies the European regulatory framework in the medical devices field. The main innovation introduced is the establishment in the European Union, of a UDI system for the unique identification of the devices. The Regulation emphasizes the importance of the role of each economic operator involved in the medical device management and supply chain during its life cycle. Manufacturers, authorised representatives, importers and distributors must now ensure compliance with the new requirements and take on specific responsibilities. This technical report, primarily intended for economic operators, analyses the new requirements for medical devices traceability introduced by Regulation (EU) 2017/745, provides tools for the correct management of medical devices and takes into account the impact of the current COVID-19 emergency on the application of the new rules.
Key words: Medical Devices; Medical device Legislation; Unique device identification; Traceability; Supply Chain; Product Recalls and Withdrawals; Patient Safety; Coronavirus