Tuesday, November 30, 2021

EU MDR Classification Rules

 Hi friends!!!

In our previous blog, we have discussed about the following topics.

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

EU MDR Technical Documentation - Part 1

EU MDR Technical Documentation - Part 2

EU MDR General Safety and Performance Requirement

EU MDR Information on the Label

EU MDR Post Market Clinical Follow Up

EU MDR Unique Device Identification - Part 1 

EU MDR Unique Device Identification - Part 2

EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe. 

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 requirements for Medical Device Classification.

Let’s discuss in detail about the Classification Rules as per EU MDR 2017/745.



In EU MDR 2017/745, Annex VIII Classification Rules talks about Medical Device Classification. Annex VIII has following chapters.

Chapter 1: Definitions specific to classification rules

Chapter 2: Implementing rules

Chapter 3: Classification rules


In EU MDR Medical Device is Classified as following

Class I

Class Is – Products which are delivered Sterile

Class Im – Products which has Measuring Function.

Class Ir – Surgical Instruments which are Reusable

Class IIa

Class IIb

Class III


The above-mentioned classification is Based on the Risk of the Device and Classification Rules mentioned in Chapter III of Annex VIII.



For example: If the Risk of the Device is Low, Device will be classified as Class I in consideration with the Classification rules. If the Risk of the Device is High, Device is classified as Class III in consideration with Classification rules. (Risk increases, medical device class also increases & vice versa).

Level of Risk possessed by Medical Device is based on following criteria.

1.    Intended Use.

2.    Duration of Use.

Transient Use: Normally intended for continuous use of less than 60 minutes.

Short Term Use: Normally intended for continuous use of 60 minutes – 30 days.

Long Term Use: Normally intended for continuous use of more than 30 days.

3.    Patient Exposure.

4.    Type of Device.

5.    Invasiveness. 

6.    Based on the Severity of harm.


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The Classification Rules are grouped into four.

1. Non-Invasive Devices.

    Non-Invasive device covers Rule 1 – Rule 4.

2. Invasive Devices.

    Invasive Device covers Rule 5 – Rule 8.

3. Active Devices.

    Active Devices covers Rule 9 – Rule 13.

4. Special Rules

    Special Rules covers Rule 14 – Rule 22.


The actual rules are as follows:

Rule 1– Non-invasive devices.

Rule 2 – Non-invasive devices intended for channeling or storing (including cells).

Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids, other liquids and cells.

Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane.

Rule 5 – Devices invasive in body orifices.

Rule 6 – Surgically invasive devices for transient/impermanent use.

Rule 7 – Surgically invasive devices for short term use.

Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc).

Rule 9 – Active therapeutic devices intended to exchange or administer energy.

Rule 10 – Active devices for diagnosis and monitoring that emit ionizing radiation.

Rule 11 – Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes (from class I to class III).

Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances.

Rule 13 – All other active devices.

Rule 14 – Devices incorporating a medicinal substance including human blood or plasma

Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases

Rule 16 – Specific disinfecting, cleaning, and rinsing devices

Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation

Rule 18 – Devices utilising non-viable tissues or cells of human origin or tissues of animal or derivatives

Rule 19 – Devices incorporating or consisting of nanomaterial

Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation

Rule 21 – Substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed

Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management

Now I hope you have acquired some knowledge about EU MDR 2017/745 Classification Rules. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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