Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
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.
EU MDR MEDICAL DEVICE
CLASSIFICATION
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.
RISK CLASSIFICATION
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.
Image courtesy: WikipediaLicensed under: CC Share Alike
CLASSIFICATION RULES
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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x ray machine working principle
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