Risk management in the development process
From the idea to launching the product: The most important steps in the development of medical devices – read more in our blog.
General safety and performance requirements: What applies to medical devices under MDR and IVDR?
For medical devices, the following applies within the EU: No CE marking and thus European market authorisation without complied general safety and performance requirements and conformity assessment procedure. Therefore the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Regulation (EU) 2017/746 – MDR and IVDR for short -, specify concrete requirements.
So what applies to manufacturers of medical devices or in vitro diagnostic medical devices? What requirements do you have to meet in order to demonstrate that the general safety and performance requirements are fulfilled for your conformity assessment procedure?
General safety and performance requirements for medical devices (according to MDR, Annex I):
Risk-benefit ratio
At first, the health of patients and users is the most important issue. The medical device must fulfil its intended purpose under normal use. This is why medical device manufacturers must prove that their medical devices are safe and effective and that the risks are acceptable in comparison to the benefits. It is also required to use a generally recognised state of the art in the manufacture of medical devices.
Risk management system
Furthermore manufacturers are required to maintain a risk management system throughout the product life cycle. The MDR requires a continuous, iterative process with constant updating of new knowledge.
Risk control
In order to control the risks, manufacturers must comply with specified safety principles with regard to generally recognised technology. In order to make the residual and overall risk acceptable, the following applies:
Manufacturers must then provide information about the other residual risks.
Usability
Products must be resilient, be able to withstand transport and storage without damage, e.g. temperature fluctuations, and ensure that they achieve their intended use. On top, the prerequisite is always the proper use of the medical device under normal circumstances.
Detailed safety and performance requirements for the manufacture of medical devices with, for example, chemical or biological properties, materials of biological origin or specifications for radiation protection can also be found in Annex I of the MDR.
What are the general safety and performance requirements for in vitro diagnostic medical devices under the IVDR?
In general, exactly the same requirements apply to in vitro diagnostic medical devices as to medical devices. Only one additional point is added in the IVDR. With reference to Annex XVI, products without a medical purpose (e.g. contact lenses, tattooing and piercing products or devices for removing fatty tissue) are also covered by the risk minimisation requirements. And once again, the health and safety of the user and the patient are of primary importance.
How do you keep track of all the general safety and performance requirements in compliance with the standard?
The first section of Annexes I of MDR and IVDR provide a first insight into what is necessary in manufacturing to meet the general safety and performance requirements. However, the eight and nine points are not a comprehensive description, as details follow for all forms of medical devices and in vitro diagnostics.
The Essential Requirements Module of the BAYOOSOFT Risk Manager offers a way to keep track of all requirements in conformity with the standards. This is because the integrated checklist filter with a standard-compliant question structure of this module enables you to speed up the review and evaluation of requirements. Through an interactive checklist, the solution filters requirements according to your medical device so that you only have to answer the relevant questions. Standard conformity is thus granted not only with the MDR and IVDR, but also with ISO 14971.
