Medical Device Regulation: major changes in classification? (1/3)
Classification according to MDR, Part 1
The Medical Device Regulation has not only introduced many innovations, but also increased the documentation effort for many requirements already existing under the directive.
One, if not the central element in the development process of a medical device is the classification of the device. Although the MDR has expanded the classification rules and specified additional regulations and individual rules, the basic process for applying the classification rules has remained unchanged. Also, classification was already documented under the umbrella of the MDD to take into account the general documentation obligations within the framework of a quality management system.
Especially devices in innovative areas are affected.
For many manufacturers of medical devices with proven technologies, the change in classification rules will hardly change anything. The changes mainly affect products in very innovative areas, made of novel materials or with new technological principles of action. Products in the high-risk area are also affected, but for many of these products the highest risk level was also applicable up to now, so that there is rarely any change here either. The situation is different for software manufacturers, who now must deal with significantly stricter regulations explicitly applying to software.
One effect of the changed regulations for the conformity assessment procedures is often, wrongly, attributed to the changes in the classification rules: For class IIb implants, a conformity assessment procedure will be imposed on manufacturers in the future, which corresponds to that of class III products. As a rule, however, the classification of the products will not change. This means that previous class IIb implantable devices will not automatically become class III devices under the MDR. In practice, however, these products will now go through nearly the same approval process as high-risk products.
So no big deal?
Not entirely, because a requirement of the MDR that relates to classification, or more precisely to the documentation of classification, results from Annex II regarding the technical documentation. In paragraph 1.1, the following contents are required as part of the technical documentation:
e) the rationale for the qualification of the product as a device;
f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII.
Such documentation has also been requested in the past by some notified bodies as a "classification rationale". This requirement goes beyond the classical documentation of classification as it is often handled. "Product XY is a medical device according to Article 1 (2)a of Directive 93/42/EC and is classified as Class IIa under Rule 5 Annex IX of the Directive."