Medical Device Classification in the European Union
Dr. Nancy Agens, Head,
Technical Operations, Pepgra
sales@pepgra.com
In Brief
Different medical devices have different
parameters through which it can be
classified. With that reasoning, it does not
make sense to subject all medical devices to
stringent conformity assessments.
Moreover, the onus of classifying a medical
device is the responsibility of the medical
device manufacturer. The device
manufacturer has to be aware about the
class under which their device will fall
under, right from the time the device is in
the process of development.
Keywords: Device Manufacturers,
Classification, CE Mark, MDD, AMIDD,
Europe
I. PHILOSOPHY OF MEDICAL DEVICE
CLASSIFICATION
In terms of practice it cannot be
economically justified nor is it feasible to
make all medical devices go through every
stringent assessment in terms of conformity.
A system of control which is graduated
should be more than enough. Under the
tenets of such a system, the degree of
control matches with the degree of possible
risks innate within a specific device type.
This warrants the need for a system for
classifying medical devices. This ensures
that medical devices are applied through the
required process for evaluating conformity
(Wheeler, 2018). With a view to ensure that
evaluation of conformity as per the
European Union Medical Device Directives
operates in an effective manner, it is
imperative that manufacturers are in a
position to determine the category under
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which their devices will classified right from
the very initial developmental phase of the
device. Thus, the need was felt to establish a
system of rules for device classification as
under the Directive. This would allow all
device manufacturers to classify their own
devices.
The system of classification of
medical devices is based on risk on the basis
of susceptibility of the human body while
keeping in mind the potential hazards linked
with the device. An approach of such kind
facilitates the utilization of a preset criterion
that could be amalgamated in diverse
manners with a view to determine
classification (Global Legal Research
Center, 2014). For eg., the time period
during which the device is in contact with a
human body, the level of the device’s
invasiveness and systemic vs. local effect.
Such criterions could then be applied to an
extensive array of diverse medical devices
and technologies. These are commonly
termed as the rules for classification and
have been outlined within Annex IX of
Directive 93/42/EEC. To a large degree, it
matches to the rules of classification setup
by the Global Harmonization Task Force
(GHTF) within the guidance document
GHTF/SG1/N15:20063.
Prior to a medical device being
legally classified by manufacturers as ‘CE’
within Europe, it is mandatory that they
adhere to the appropriate medical device
directive or regulation as outlined by the
European Commission (EU). It is critically
very significant to be aware of the
appropriate medical device classification for
a particular product prior to placing a ‘CE’
mark on the device. Regulatory
requirements are impacted through device
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classification and also the route for approval
along with associated costs (French-Mowat
& Burnett, 2012).
II. MEDICAL DEVICE CLASSIFICATION
IN EUROPE
The initial step within the regulatory
process in Europe would be to determine the
directive that is applicable to a particular
product. A large number of devices fall
under the medical device directive
93/42/EEC, however, there are certain high
risk devices such as implantable devices that
needs to adhere to the Active Implantable
Medical Devices Directive (AIMDD)
90/385/EEC. At the same time, the In Vitro
Diagnostic Directive (IVDD) 98/79/EC is
applicable to In Vitro Devices (IVDs)
(HPRA, 2009). In case, a manufacturer opts
to project adherence to regulation, the
Medical Device Regulation (MDR) No.
2017/745 (for active implantable devices or
medical devices), or the In Vitro Diagnostic
Device Regulation (IVDR) No.2017/746
would be taken into account. A rule based
scheme of classification is utilized by
Europe for medical devices which fall under
the ambit of MDD. There are around 18
rules which have to be adhered to and these
Rules Device
Rules 1-4 Non-Invasive Devices
Rules 5-8 Invasive Devices
Rules 9-12 Active Devices
Rules 13-18 Special rules e.g. devices containing tissue of animal origin, due-device
combinations
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can be referred to in Annex IX of the MDD.
Though the overall structure of the rules
from MDD is maintained in the MDR, there
is scope for expanding the rules
(McDonough, 2019).
III. SEGMENTATION OF MEDICAL
DEVICES WITHIN EUROPE
On the whole, every medical devices
can be segmented into four key categories.
These would include;
 Non-invasive medical devices
 Invasive medical devices
 Active medical devices
 Special Rules (comprising of
disinfectant, contraceptive and
radiological diagnostic medical devices)
or devices comprising of animal tissue or
drug-device combination.
The above said 18 rules as specified
within Annex IX of the Directive and
pertinent regulation lay down the
fundamental principles for classification. As
per MEDDEV 2.4/1 Rev.8, such rules are
additionally elucidated with descriptive
samples. The 18 rules are further bifurcated
into four groups.
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 Furthermore, the MDR has also
framed certain special rules that also cover
Nano-materials (Donnell, 2016). Medical
devices are further segmented as per the
classes as mentioned below. IVDs are
known to have their individual scheme of
classification whereas, active implantable
medical devices fall under the scope of
similar requirements as that of class III
devices (the MDR also includes active
implantable medical devices).
 Class Ia – Provided non-sterile or
devices that are devoid of a measuring
feature (low risk)
 Class Ib – Provided sterile and / or is
inclusive of a measuring feature
(low/medium risk); to this group
reusable surgical instruments as Class I
reusable surgical instruments have been
added by the MDR.
 Class IIa – (medium risk)
 Class IIb – (medium or high risk)
 Class III – (high risk)
IV. WHEN TO APPLY THE HEALTH
PRODUCTS REGULATORY
AUTHORITY (HPRA) FOR
DETERMINING CLASSIFICATION
As mentioned above, it is the
responsibility of the device manufacturer to
determine the right class for their product.
Subsequently, the basic responsibility for
device classification rests on the
manufacturer. The manufacturer is supposed
to confirm classification with a Notified
Body (NB) of their preference. In case there
is uncertainty or any kind of difference of
opinion between the manufacturer and the
NB, it is essential to refer the issue to a
competent authority for arriving at a
decision (HPRA, 2009). The HPRA also
accepts formal requests on the part of the
manufacturer for classifying a medical
device, drug-device combination and
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borderline product before submitting an
application for CE marking to a NB or
before notification pertaining to the register
of Class I devices. Formal requests for
classification are also accepted by the HPRA
from other interested parties or individuals.
All interested parties can download the
relevant form ADV-F0006 for medical
device classification, from ‘publications and
forms’ section of the HPRA website.
REFERENCES
[1] Donnell, M.O. (2016). Nanomaterials and medical
device regulations Nanomaterials. [Online].
Available from:
https://www.bsigroup.com/globalassets/meddev/loca
lfiles/en-gb/webinars/bsi-md-nanomaterials-
presentation-30-nov-2016.pdf.
[2] French-Mowat, E. & Burnett, J. (2012). How are
medical devices regulated in the European Union?
Journal of the Royal Society of Medicine. [Online].
105 (1_suppl). pp. 22–28. Available from:
http://journals.sagepub.com/doi/10.1258/jrsm.2012.1
20036.
[3] Global Legal Research Center (2014). Approval of
Medical Devices. [Online]. 6462 (September). pp.
23. Available from: www.law.gov.
[4] HPRA (2009). Guide to Classification of a Medical
Device. Health Products Regulatory Authority.
[Online]. 1 (1). pp. 3–11. Available from:
https://www.hpra.ie/docs/default-
source/publications-forms/guidance-documents/adv-
g0004-guide-to-classification-of-a-medical-device-
v2.pdf?sfvrsn=10.
[5] McDonough, C. (2019). Medical devices regulation
countdown. [Online]. 2019. Available from:
http://www.pharmatimes.com/web_exclusives/medic
al_devices_regulation_countdown_1277912.
[6] Wheeler, M. (2018). Classification Of Medical Devices
Under The Eu Mdr. [Online]. 2018. Available from:
https://emmainternational.com/classification-of-
medical-devices-under-the-eu-mdr/.
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