{"id":656,"date":"2026-03-06T10:36:01","date_gmt":"2026-03-06T07:36:01","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=656"},"modified":"2026-03-06T10:43:55","modified_gmt":"2026-03-06T07:43:55","slug":"devices-in-one-technical-documentation-mdr","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/devices-in-one-technical-documentation-mdr\/","title":{"rendered":"How Many Devices Can Be Included in One Technical Documentation under MDR?"},"content":{"rendered":"
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Under the European Medical Device Regulation (EU) 2017\/745 (MDR), manufacturers are required to prepare technical documentation demonstrating the conformity of their medical devices with the applicable regulatory requirements. A frequently asked question from manufacturers is whether a single technical documentation file can include multiple devices.<\/p>\r\n

The MDR does not specify a numerical limit for the number of devices that can be included in one technical documentation. Instead, the acceptability of grouping multiple devices in one file depends on whether the devices belong to the same device family and share common characteristics.<\/p>\r\nIn practice, the number of technical documentation files prepared under MDR is also an important strategic consideration for manufacturers. Each technical documentation file submitted to a Notified Body typically requires a separate assessment during the conformity assessment process. Since MDR certification has become significantly more resource-intensive compared to the previous regulatory framework, the number of technical documentation files may directly influence certification costs and review timelines. For this reason, many manufacturers try to group device variants within the same device family into a single technical documentation file when it is scientifically and regulatorily justified.\r\n

Regulatory Basis<\/h2>\r\n

The structure and content of technical documentation are defined in Annex II and Annex III of Regulation (EU) 2017\/745. These annexes describe the documentation required to demonstrate device safety, performance, and compliance with the General Safety and Performance Requirements (GSPRs).<\/p>\r\nAlthough the MDR does not explicitly define the maximum number of devices allowed in a single technical documentation, the concept of device families and Basic UDI-DI grouping provides the regulatory framework for determining appropriate grouping. Manufacturers preparing technical documentation under MDR<\/strong> must ensure that device grouping is properly justified.\r\n

Device Family and Basic UDI-DI<\/h2>\r\n

According to MDCG 2018-1 guidance on UDI assignment, the Basic UDI-DI is the primary identifier used to group medical devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.<\/p>\r\n

Devices can generally be included in the same technical documentation when they share:<\/p>\r\n\r\n