Classification of medical devices under the European Medical Device Regulation 2017/745
- November 12, 2018
- Posted by: confinis
- Category: confinis
After elaborating on Transition Periods and Definitions in our last post, today’s article focuses on the Classification of Medical Devices under the new European regulation.
While there are no essential changes in the classification approach (see article 51 of the European MDR) as we are used to from MDD, there are additional classification rules outlined in annex VIII to integrate also the AIMD and for differentiation of some specific products, for example software or devices made of substances (see below)
The presentation MDR Classification starts with an outline of the cross references relevant for classification of medical devices within the regulation. The core of the presentation provides you with a comprehensive overview of similarities, changes and additions of the classification rules in the MDD in comparison to EU MDR 2017/745. You will find this breakdown of information separately for each rule comprised in annex VIII of the regulation. If applicable, the comparative outline for each rule also provides cross references to applicable additional regulations and directives.
There are 4 rules in the EU MDR which are new and hence no comparison to the MDD or AIMDD can be made. Let us have a brief look into those new rules.
Rule 11 even though not entirely new, does not have a corresponding rule in the MDD or AIMDD. It sets the standard for if and how software is to be classified as medical device. If a software is used to take decisions regarding diagnosis or therapeutic purposes it is classified as class IIa, unless such decisions have an impact that may cause death or irreversible deterioration of a person’s state of health, which would be a class III medical device. If a software might cause serious deterioration of a person’s state of health or surgical intervention, it is classified as class IIb. Software for monitoring of physiological processes is classified as well as class IIa. However, if the parameter monitored is of such nature that variation in such parameter leads to immediate danger for the patient, it is a class IIb medical devices. All other software is classified as class I.
With rule 19, the EU MDR addresses specifically nanomaterials, which, depending on the risk associated to internal exposure are defined to be class IIa, IIb or III.
Rule 20 sets the standards for the classification of invasive devices intended to administer medicinal products by inhalation. Class IIa is valid for all such devices except of those aiding in the treatment of life-threatening conditions, which makes them a class IIb device.
Rule 21 defines devices composed of substances or combination of substances to be class III products, unless they are applied to the skin or the nasal and oral cavity and achieve their intended purpose on those cavities. In such case, the devices are class IIa. Class IIb is applicable to all other cases.
Rule 22 addresses so called “Automated Control Systems” which are class III medical devices.
What is the most important task for you to execute?
Check the classification of your products under the European MDR. Do you identify products which will be classified higher than under MDD?
If so, identify the appropriate Conformity Assessment Procedure for the certification of such products and prioritize them in your implementation plan to secure enough time for the remediation activities to achieve recertification under the EU MDR.
To provide you with supportive material for the identification of the appropriate Conformity Assessment Procedure, this topic will be next in our series regarding the new European Medical Device Regulation 2017/745.
Start evaluating the classification of your products under the new EU regulation now.
We are ready to act! Are you as well? Let us know!
by Joachim Makowski, MED-RAS GmbH*
To see previous publications in this series, go to https://www.confinis.com/blog/
*partners to confinis ag: Frikart Engineering GmbH, MED-RAS GmbH, Bernd Juhre