{"id":33144,"date":"2024-10-15T16:27:45","date_gmt":"2024-10-15T14:27:45","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/10\/15\/la-gestione-delle-modifiche-nei-dispositivi-medici-in-unione-europea-e-nei-paesi-mdsap\/"},"modified":"2024-10-15T16:36:29","modified_gmt":"2024-10-15T14:36:29","slug":"la-gestione-delle-modifiche-nei-dispositivi-medici-in-unione-europea-e-nei-paesi-mdsap","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/10\/15\/la-gestione-delle-modifiche-nei-dispositivi-medici-in-unione-europea-e-nei-paesi-mdsap\/","title":{"rendered":"Medical Devices Change Management in the European Union and MDSAP Countries"},"content":{"rendered":"

Change management in medical devices is essential to ensure European and international compliance. After the product is first placed on the market, changes in the post-market phase<\/strong> must be monitored and managed, respecting the regulatory requirements of each country where the medical device is marketed. Ineffective and non-compliant management can lead to sanctions, and delays, up to and including withdrawal from the market.<\/p>\n

Generally speaking, changes may concern various aspects of the product and process. Examples include design changes (structural changes or new functionalities), replacement of materials with potential clinical and biological impacts, changes in the production process and labelling, and changes affecting the quality management system.<\/p>\n

Evaluation of Changes: Substantial vs. Insignificant<\/strong><\/h2>\n

When a manufacturer changes a medical device, it is essential to assess whether these changes are substantial (‘substantial change’)<\/strong> and whether they require specific procedures, such as re-registration, updating of authorisations or new conformity assessment. The classification as substantial depends on various factors, mainly the impact on the safety <\/strong>and effectiveness<\/strong> of the device and the requirements of each country.<\/p>\n

Each country has specific requirements regarding change management<\/strong>. For example, a change that does not require re-registration in the US, under FDA supervision, might need a full review in the EU according to MDR (EU) 2017\/745. Even in the context of the MDSAP<\/strong> (Medical Device Single Audit Program), device changes must be managed according to the regulatory requirements of each of the five participating countries (Australia, Brazil, Canada, Japan and the United States).<\/p>\n

A look at the changes in Medical Devices in the EU and MDSAP countries<\/strong><\/h2>\n

European Union<\/strong><\/p>\n

According to MDR (EU) 2017\/745 <\/strong>and IVDR (EU) 2017\/746<\/strong>, a modification to a device is considered significant<\/strong> if it affects the design<\/strong> or intended use<\/strong>, requiring a new conformity assessment<\/strong> and, potentially, a new certification<\/strong>.
\nIn the case of significant changes, the Notified Body must be involved to confirm whether the certification remains valid or whether further steps are required.<\/p>\n

Significant changes<\/strong>, according to NBOG BPG 2014-03 guideline, include:<\/p>\n