Introduction to Medical Devices

Slide 1:
Today I am going to talk about the introductory part of Medical Device field. Let us
start with Part 1 i.e. Introduction to Medical Devices.

Slide 2:
The topics I would be dealing today are:
I hope you know about European Union. It includes 28 Member States. Some of
which are; Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden
and United Kingdom. These Member States differ in their constitutional and legal
systems.
IMDRF is International Medical Devices Regulators Forum.

Slide 3:
My target after this lecture is to acquaint you with:

Slide 4:
The first thought that comes to my mind when I hear Medical Device is that it is
composed of two words Medical and Device that means a device which is used for
medical purpose. This is a very broad sentence. Let us zoom a little further.
Device means it can be an instrument, apparatus or appliance. Now the medical use
will be prevention, diagnosis, treatment or monitoring of disease/injury or a
handicap.
You would comment that is the function of Drugs. Of course there is a catch that
Medical Devices do not achieve their principal intended action on the human body
by pharmacological, immunological or metabolic means.
I think the concept is clear now. This means that medical devices are everything
from band aids to x-ray machines, contact lenses, hip implants, pacemakers,
crutches, hospital beds and in vitro diagnostic devices. That we will be discussing in
the next lecture in detail.

Slide 5:
Here are some examples of Medical Devices. I know we understand more with
pictures. Here you can see in the first line are Dialysis Machine, tanning bed,
respiratory mask, otoscopes, diagram of an artificial heart, sulzer hip.
The second line has injection, cat scan machine, coronary stent, gloves and a full
body scanner.
The last line has an actual artificial heart, infusion pump, in-vitro diagnostic test,
microwave, stethoscope and a box of band aids. These all are different examples of
Medical Devices.

Slide 6:
Until now I gave a general idea about different medical devices. Now let us look at
the specific definitions. So, first in line is the UFDA definition. USFDA stands for
United States Food and Drug Administration. Medical devices are defined in section
201(h) of the federal food drug and cosmetic act.
The first three lines define clearly the word Device
The rest clarifies the word Medical including the catch phase I mentioned earlier.
One important thing in the USFDA definition is that some medical devices are
recognized in the official National Formulary or US Pharmacopoeia.

Slide 7:
Moving on to the definition given in the EU Directives
The format is the same I explained earlier.
The important thing to note however, that it includes the software intended by its
manufacturer to be used specifically for diagnostic and/or therapeutic purposes
Also, control of conception is included.

Slide 8:
In India Medical devices are specified by central government by notification in
official gazette. These notified medical devices are considered as drugs under D&C
Act Section 3 clause (b) sub clause (iv)
We can see that this definition includes specific devices and leaves the room for
ambiguity for rest of the devices. So there is a need of amendment.

Slide 9:
Medical device definition proposed in the Drugs and cosmetics amendment bill of
2015 however includes the extensive definition. Some points to note that Medical
devices include devices for supporting or sustaining life and devices for disinfection.

Slide 10:
An accessory is also proposed to be considered as a medical device.
In-vitro diagnostic Medical devices are also described which will be dealt in detail
later.

Slide 11:
Let us talk about the Regulation of Medical devices in US

Slide 12:
Next let us look into Regulation of Medical Devices in European Union

Slide 13:
In India, The Medical devices are regulated by CDSCO.

Slide 14:
Medical Device Classification in US is Risk Based present in 21 CFR Part 860.
There are three classes, class I, II and III. Class III is the highest risk class.
Examples of devices of various classes are:
Class I: elastic bandages, examination gloves
Class II: Infusion pumps, surgical drapes
Class III: Implantable pacemaker, pulse generators, heart valves
There are about 780 generic groups of devices in Class I, 800 in Class II and 120 in
Class III.
I will give you an idea about different types of controls.
General controls:

Adulteration / Misbranding

 Electronic Establishment Registration

Electronic Device Listing
Premarket Notification [510(k)]
Quality Systems
Labeling
Medical Device Reporting (MDR)
Special controls:
Guidelines (e.g., Glove Manual)
Mandatory Performance Standard
Recommendations or Other Actions
Special Labeling (e.g., 882.5970, Cranial Orthosis)
Guidance Documents

Slide 15:
Medical Device Classification in EU is also Risk Based defined in Annex IX, MDD
93/42/EEC.
The classes are, class I, IIa, IIb and III. Class I devices are divided on the basis of
sterility and measuring function also. Devices in Class I are used for less than 60
minutes continuously.
Class II devices are classified into two groups based on based on duration of use.
Class IIb is the higher risk class with longer duration of continuous contact i.e. more
than 30 days.
Class III is the highest risk class.
Examples of devices of various classes are:
Class I: Low risk non-invasive devices like non sterile wound dressings and
stethoscopes
Class IIa: Medium risk short term invasive devices like tracheal tubes and lancets
Class IIb: Higher risk often longer term surgically invasive, sometimes implantable
devices including intra ocular lenses and surgical lasers

Class III: Highest risk devices, including all active implantable devices such as
replacement heart valves and vascular stents

Slide 16:
There is no classification of Medical Devices in India. There are only 14 notified
devices which are:
The notification number and the date of official notification are mentioned against
each of the Notified device.

Slide 17:
There are some medical devices which are regulated as Drugs under Drugs and
cosmetics act. They are:

Slide 18:
In the drugs and cosmetics amendment bill of 2015, it is proposed that Central
Government will have the powers to make rules for classification to regulate notified
category of Medical Devices. They will consult Medical Devices Technical Advisory
Board to do so.

Slide 19:
A nomenclature is usually given to a medical device when it is classified. There are
two international nomenclatures that are very common.
1. The UMDNS terms are harmonized with the classification system of the USA
and exist in ten languages.
2. The GMDN terms only exist in English but can be translated with special
software. This nomenclature system is required for registering a medical
device within the EU.
Both systems consist of defined terms that describe a group of products with similar
characteristics. The GMDN system is developed from 6 different nomenclature
systems and the UMDNS system is one of them. GMDN and UMDNS harmonize with
each other but GMDN has more terms and is therefore preferred.

Slide 20, 21, 22

Slide 23:
The organization GHTF (Global Harmonization Task Force) no longer exists, and has
been permanently replaced by the IMDRF. GHTF was conceived in 1992 comprised
of five Founding Members: European Union, United States, Canada, Australia and
Japan.
The present organization IMDRF was conceived in February 2011 and is composed
of more Members like Brazil, China and Russia.

Slide 24:
The official observers of IMDRF are World Health Organization and
APEC : Asia pacific economic co-operation
LSIF: Life science innovation forum
There are two affiliate organizations of IMDRF; Asian harmonization working party
and Pan American Health Organization.

Slide 25:
Most recent IMDRF Meeting was held in Tokyo (Japan). It was the7 th IMDRF which
was organized from 24th 26th March 2015. Meeting decisions were:
1. First is MDSAP. Guidance on Regulatory Authority Assessment Methods of
Auditing an Organizations Processes and Medical Device Regulatory Audit
Reportsare considered for 2 month public consultation
2. Second regarding post marketing surveillance of Medical Devices; the working
group of National Competent Authority Report Exchange Criteria and Report
Formwill work on detailed pilot plan.
3. QMS for Software as medical device Document is considered for 2 month public
consultation.
4. There would be Development of common terminology and code related to
adverse event of medical device

Slide 26:
The working group in charge of ISO 13485 is ISO TC 210 WG1.

During the meeting for the published draft version ISO DIS 13485:201X voting the
draft was not accepted. There will be new rounds of comments which make the
objective of publishing the final version in 2015 very unlikely.
In Europe, medical devices are regulated the same way since the 1990s.
Now, almost 20 years and several major scandals later, EU officials are preparing a
massive overhaul of the region's medical device regulatory directives to modernize
the system
If only they could agree on what those changes should look like.
It wasn't supposed to happen this way. In 2008 and 2010, the European Commission
was planning on making incremental updates.
But shortly thereafter, there were two major device safety scandals. In the first,
French company, Poly Implant Prothese was found to have distributed breast
implants manufactured using industrial, rather than medical grade, silicone. In the
second, metal-on-metal hip implants were found to be failing much faster and worse
than anticipated, requiring many patients to undergo corrective surgeries.
After this, it was considered that a more in-depth revision of the rules was
necessary.
But while the need for reforms to the device directives has been clear for some
time, the exact reforms to be made have been a matter of lengthy debate.

Slide 27:
On May 19th 2015, U.S. House of Representatives introduced 17 separate bills to
amend the Federal Drugs and Cosmetics Act.
H.R. 2426 is with respect to easing regulatory burden with respect to certain class I
and class II devices.