Medical Device Classification in the European Union – Pepgra.com

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MEDICAL DEVICE CLASSIFICATION IN THE EUROPEAN
UNION
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS
In Brief
Medical Device Classification Medical Device
Classification in Europe Segmentation of Medical
Devices Medical Device Classes Health Products
Regulatory Authority (HPRA)
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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. 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.

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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. 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 which their devices will
classified right from the very initial
developmental phase of the device. Contd..
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For eg., the time period during which the device
is in contact with a human body, the level of
the devices invasiveness and systemic vs. local
effect. Such criterions could then be applied to
an extensive array of diverse medical devices and
technologies. 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/N1520063. Regulatory
requirements are impacted through device
classification and also the route for approval
along with associated costs.
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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. The In Vitro Diagnostic Directive
(IVDD) 98/79/EC is applicable to In Vitro Devices
(IVDs). The Medical Device Regulation (MDR) No.
2017/745 , or the In Vitro Diagnostic Device
Regulation (IVDR) No.2017/746 would be taken into
account.
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Segmentation of Medical Devices
Every medical devices can be segmented into four
key categories Non-invasive medical devices
Invasive medical devices Active medical
devices Special Rules or devices comprising of
animal tissue or drug-device combination. Contd..
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Table 1 18 Rules
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Medical Device Classes
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)
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Health Products Regulatory Authority (HPRA)
The manufacturer is supposed to confirm
classification with a Notified Body (NB) of their
preference. The HPRA accepts formal requests on
the part of the manufacturer for classifying a
medical device, drug-device combination and
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.
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