All you need to know about the Technical Documentation
A medical device can only be placed on the European market once the manufacturer declares conformity of the device with applicable EU Regulations. Manufacturers provide evidence for conformity with the applicable regulations with a set of documents that describe comprehensively the medical device, including, among many other aspects, the intended purpose, design, manufacturing, verification and its validation. This set of documentation is called Technical Documentation (TD). The expected content of a TD is set out in the Annexes II and III of Medical Device Regulations EU 2017/745 (MDR)1 and EU 2017/746 (IVDR).
Interpret and implement standards and regulation with ease
BSI Compliance Navigator is the only platform designed by regulatory experts to help manage your medical device compliance, all in one place. Access thousands of standards and regulations, from MDR and IVDR to MDSAP requirements, we have you covered.
What's more, Compliance Navigator will alert you of any upcoming changes to relevant standards and regulations, meaning you can prepare, far in advance. Use our Tracked Changes to see what's changed quickly and efficiently, followed by our Expert Commentary to help interpret and implement with ease. Save time, reduce risk and unlock market access with Compliance Navigator.
