Good to know
Depending on the assigned risk class of the medical device, manufacturers must involve their Notified Body for the conformity assessment procedure. The risk class determines whether this is necessary.
The MDR and IVDR make manufacturers responsible for the risk classification of medical devices. They or an authorised person must therefore decide on the basis of the intended purpose and individual information what risk the medical device or in vitro diagnostic device (IVD) poses. A process that certainly requires detailed knowledge of the classification rules according to the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) (EU) 2017/746).
Can the process be facilitated? And how does the risk classification succeed automatically?
You have already developed a similar medical device – so surely the classification of the new product is in the same risk class? Unfortunately, it is not quite that simple, because the Federal Institute for Drugs and Medical Devices (BfArM) rules out the blanket classification into risk classes based on product groups. The reason for this is that the classification is always based on the intended purpose and individual information provided by the manufacturer.
In addition, a separate risk classification must be made for each medical device – even if both components are connected to each other or if accessories are involved.
The classification of medical devices:
The classification is made into the four risk classes I, IIa, IIb and III (low to high risk in ascending order). In addition, a distinction must be made for class I products according to sterile application (Is) or the presence of a measuring function (Im).
By the way: Standalone software, i.e. medical software that is not used as control software of a medical device (e.g. medical apps) is also considered an active medical device according to MDR and BfArM. The preparation of the intended purpose and risk classification is therefore the responsibility of the manufacturer and can, if necessary, be carried out after consultation with the Notified Body.
The classification of in vitro diagnostic medical devices:
According to the IVDR, in vitro diagnostic medical devices are divided into classes A, B, C and D (low to high risk in ascending order). Only for class A medical devices is it possible for manufacturers to declare conformity themselves for market placement; for the other risk classes, the Notified Bodies must be involved in the conformity assessment procedure.
Simplify processes thanks to automation
Since the classification into risk classes must be decided for each individual medical device based on its intended purpose, it is inevitable to be able to safely apply all rules of the MDR and IVDR. While the IVDR comprises seven rules, a total of 22 rules apply to medical devices according to MDR.
Instead of manual application, an automated software solution can safely support you in this process. Because a structured and fine-granular solution can guide you through the classification process.
Our latest solution for you: BAYOOSOFT Themis – the future of technical documentation. With the help of the Documentation Guide, you are guided step by step through the classifier. In this way, you can easily determine the assignment of the risk class by answering predefined questions.
Read more about BAYOOSOFT Themis and the Documentation Guide here.
At BAYOOSOFT Themis we have rethought technical documentation.
With the validated software solution for documentation processes of medical devices and in-vitro diagnostics, you digitize linked processes and sustainably reduce documentation efforts. At the same time, you minimize redundant data.
Get to know BAYOOSOFT Themis in a product presentation.
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Contacts at BAYOOSOFT
Svenja Winkler
CEO
[email protected]
Franziska Weiß
Head of Sales
[email protected]
