Video: MDR – General Safety and Performance Requirements
In the third of our MDR video series, Martin Witte, TÜV SÜD Global Director Active Medical Implants, explains the main aspects of the General Safety and Performance Requirements described in Annex I of the MDR in the almost seven-minute clip.
The general safety and performance requirements form the Annex I of the Medical Device Regulation (MDR). They are divided into three chapters:
- General requirements
- Requirements regarding design and manufacture
- Requirements regarding the information supplied with the device
In this video we give you a short overview on some of the numerous clauses that changed which you should be aware of or which you need to take into consideration.
Jumping directly to the second chapter, the requirements regarding design and manufacture: Clauses 10 to 13 cover materials, and here you will find some new requirements on substances, especially on substances that require a labeling in case they exceed a certain weight by weight limit. This is also important for manufacturers of active implantable devices, because the raw materials you use for your devices might contain substances that require labeling.
The environment is another new element in the general safety and performance requirements you need to consider, and is mentioned in clause 14. The environment might affect your device, but you also need to take into account how your device might affect the environment when it gets disposed. Thus, you need to make sure that there are safe ways of disposal for your device.
Clause 17 covers electronic programmable systems, and you will find a requirement for a single fault safety, which means that in a single fault condition your software or your programmable system still needs to be safe for patient and user. In addition to that, software needs to be developed and manufactured in compliance to the state of the art, and you need to follow the development life cycle process.
For apps that are running on mobile devices you need to consider the environment of the device, e.g. the screen resolution, but also influences like noise or light that come from the environment. Cybersecurity is as well an important point for these systems. Generally spoken, MDR recognizes that IT security is much more important today, so you need to ensure that there is no possibility for an unauthorized access or for hacking your device.
Clause 18 is relevant for active devices. Here you also find the well-known single fault safety concept for active devices. A lot of the requirements here are also included in IEC 60601.
In clause 19 the legislative tried to merge AIMD and MDD leading finally to the MDR.
In chapter III “Requirements regarding the information supplied with the device”, clause 23 covers label and instructions for use.
The label of your product must include the UDI, the unique device identifier.
You also need to inform the user about substances your device contains. Furthermore, you have to ensure that your instructions for use, regardless if you provide it electronically or in paper, include information for physicians to inform patients about any risks that are relevant for them.
If you provide your instructions for use electronically, then you have to follow the existing regulation on electronic labeling.
Even though this video focuses on Annex I, we also have to look at Annex II, because showing compliance to all these requirements from Annex I is required by Annex II, clause 4.
Annex II, clause 4 requires you to have a technical documentation where you need to provide information on how you comply with the general safety and performance requirements.
First of all, that includes an overview of the general safety and performance requirements that are applicable and those which are not. For those which are not applicable you need to provide a justification why they are not, and for those that are applicable you need to provide proof of how you comply. Basically that means you provide a test report detailing how you safeguard compliance.
This was a short overview about general safety and performance requirements. If you still have any questions on this, please feel free to contact us.
View the other videos already released in our MDR series here: