ENGLISH 23 Responsible for Regulatory Compliance, EUDAMED and UDI etc., which extend also to companies that are eligible to apply the transitional provisions in the switch from the MDD to the MDR. And even those who can afford all these things must still hope they can find a Notified Body with time on their hands... What has become clear after a good nine months of the MDR is... The new regulation is not to be sniffed at, and anyone who blindly adheres to their accustomed procedures is exposing themselves to a serious risk. Biological evaluation according to ISO 10993 We encounter surgical medical devices in a broad variety of situations, both in specific or highly specialised treatments. It is often unavoidable that the medical device will come into contact with the human body. Patient, user or third party exposure – as it is called in the legislation – varies greatly and depends on the medical device in question. The manner of this exposure, its duration and the part of the body significantly influence the Risk Class to which a medical device is assigned and how its biological safety can be evaluated. The international ISO 10993 series of standards is considered the state of the art in this regard. An evaluation of this “biocompatibility” is specifically required by testing bodies and legislators, among others in EU 2017/745 (Medical Device Regulation, MDR, Annex II). The purpose of the standard is to protect humans from potential biological risks in connection with the use of medical devices, and it provides a guideline for evaluating the biological compatibility of the materials used with the human body. The series of standards is summarised and introduced by ISO 10993-1, in the DIN version as revision 2021-05. DIN EN ISO 10993-1 is intended to provide manufacturers with a framework to obtain adequate biological evaluations of medical devices within a risk management process. It provides a recommended course of action for the classification of medical devices based on the type of contact with the body (e.g. contact with intact skin, with wounds and with the inside of the body etc.) and the duration of the contact. In this context, it proposes various tests that are described in greater detail in specific secondary standards. However, ISO 10993-1 repeatedly includes and mentions that a final report should collect and summarise the data obtained once planning and execution of the individual tests are complete. Part 7 lists the key points of a report of this kind. They are only mentioned in a summarised form in this standard, so I will briefly explain the requirements in the following.
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