11
CHAPTER 1:
Medical Devices: A History
an Executive Agency of the Department of Health known as the
MDA in September 1994.
European Directives and the Medical Devices
Regulations 2002
Before MDD and IVDD, EU Member States, including the UK,
had varying standards and procedures for medical devices. This lack
of uniformity created barriers to trade within the European single
market and potentially compromised patient safety.
Through the Department of Health, the UK government
drafted the Medical Devices Regulations 2002 to incorporate the
provisions of the EU Directives into UK law. This was necessary to
ensure that UK manufacturers could compete on an equal footing in
the EU market and that UK patients benefited from the same level
of health protection as those in other EU countries. The regulations
were subject to scrutiny by both houses of the UK Parliament.
Ultimately, the regulations set up the risk-based categorization
system that separates the medical devices into four classes based on
risk and specifies conformity assessment procedures for each class.
For example, Class I devices are considered low-risk and include
items like bandages, handheld surgical instruments, and reusable
surgical retractors. Manufacturers of these devices can self-certify
their conformity. However, they must register with the Medicines
and Healthcare products Regulatory Agency (MHRA) and ensure
a proper quality assurance system is in place. Class III devices repre-
sent the highest risk category within the UK’s medical device classi-
fication system, which mirrors the stringent regulatory frameworks
established by the EU. Devices classified under Class III include
those that are implanted into the human body and are intended
to sustain life or prevent a health condition from worsening, and
all Active Implantable Medical Devices are subject to the highest
controls and require manufacturers to undergo a thorough confor-
mity assessment that involves a notified body. This process would
include a detailed examination of the technical documentation and
design dossier to ensure compliance with safety and performance
standards. Additionally, these devices typically require clinical data
and ongoing postmarket surveillance to monitor their performance
after they have been introduced to the market.
Brexit and Changes to Medical Device Regulation
Following Brexit, the UK is no longer a part of the EU. To address
the need for medical device regulation, Great Britain has intro-
duced the UK Conformity Assessed (UKCA) marking, replacing
the CE mark for devices placed on the market in England, Wales,
and Scotland. The Medical Devices Regulations 2002 (UK MDR
2002) are the current regulatory framework. As such, the UK
continues to follow the former European Directives: Directive
90/385/EEC on active implantable medical devices, Directive
93/42/EEC on medical devices, and Directive 98/79/EC on in
vitro diagnostic medical devices. Depending on the device type
and the directives they comply with, Great Britain continues to
recognize CE-marked devices until certain dates ranging from
2028 to 2030.69
Unlike Great Britain, Northern Ireland remains under the
EU regulations and follows EU MDR and EU IVDR. Devices in
Northern Ireland require CE marking, which must be performed
by an EU-recognized notified body. If a device is assessed by a
UK notified body, it will also bear the UKNI marking. The UKCA
marking will not be recognized in Northern Ireland.
Notified Bodies
Notified bodies in the UK are now known as approved bodies.
They are no longer able to provide CE marking for devices to be
sold in the EU. Instead, they can perform conformity assessments
to provide the UKCA marking.70
Asia
China
This section delves into the development journey of modern
medical device regulation in China, maintaining its unique
Chinese characteristics while drawing on international advanced
experiences. It covers the origins, the creation of regulations,
international exchanges and cooperation, and the publication and
implementation of the newly revised Regulations on Supervision
and Management of Medical Devices (referred to as “the Regula-
tions” in the rest of this chapter).71 Furthermore, it looks forward
to the future development directions of medical device regulation
in China.
Early Beginnings
Tracing back to the late 1980s, the pharmaceutical industry
management department at the time was the State Pharmaceu-
tical Administration of China. Authorized by the State Council,
the State Pharmaceutical Administration was responsible for the
unified management of the production and market circulation of
pharmaceuticals and medical devices. However, due to the diver-
sity of the professional fields involved in medical devices and the
relatively backward production level of medical devices in China
at that time, a unified industry had not yet formed. The production
and market management of medical devices in China were carried
out by different industrial management departments.
In the late 1980s, preparations were made to establish a
department to specifically implement a unified management
program for medical devices. From 1988 to 1996, the State
Pharmaceutical Administration sent medical device management
delegations to developed countries and regions such as the US,
Europe, Canada, Australia, and Japan multiple times yearly. These
delegations conducted investigations to understand the history,
system, models, technical means, and specific laws and regulations
of medical device regulation in these countries and regions.72
Evolution of Regulatory Framework
In 1990, the State Pharmaceutical Administration reported its
plan for medical device legislation to the State Council. It began
drafting China’s administrative regulations for medical device
supervision and management based on the organization and
summary of regulatory systems, regulations, and experiences of
developed countries.
CHAPTER 1:
Medical Devices: A History
an Executive Agency of the Department of Health known as the
MDA in September 1994.
European Directives and the Medical Devices
Regulations 2002
Before MDD and IVDD, EU Member States, including the UK,
had varying standards and procedures for medical devices. This lack
of uniformity created barriers to trade within the European single
market and potentially compromised patient safety.
Through the Department of Health, the UK government
drafted the Medical Devices Regulations 2002 to incorporate the
provisions of the EU Directives into UK law. This was necessary to
ensure that UK manufacturers could compete on an equal footing in
the EU market and that UK patients benefited from the same level
of health protection as those in other EU countries. The regulations
were subject to scrutiny by both houses of the UK Parliament.
Ultimately, the regulations set up the risk-based categorization
system that separates the medical devices into four classes based on
risk and specifies conformity assessment procedures for each class.
For example, Class I devices are considered low-risk and include
items like bandages, handheld surgical instruments, and reusable
surgical retractors. Manufacturers of these devices can self-certify
their conformity. However, they must register with the Medicines
and Healthcare products Regulatory Agency (MHRA) and ensure
a proper quality assurance system is in place. Class III devices repre-
sent the highest risk category within the UK’s medical device classi-
fication system, which mirrors the stringent regulatory frameworks
established by the EU. Devices classified under Class III include
those that are implanted into the human body and are intended
to sustain life or prevent a health condition from worsening, and
all Active Implantable Medical Devices are subject to the highest
controls and require manufacturers to undergo a thorough confor-
mity assessment that involves a notified body. This process would
include a detailed examination of the technical documentation and
design dossier to ensure compliance with safety and performance
standards. Additionally, these devices typically require clinical data
and ongoing postmarket surveillance to monitor their performance
after they have been introduced to the market.
Brexit and Changes to Medical Device Regulation
Following Brexit, the UK is no longer a part of the EU. To address
the need for medical device regulation, Great Britain has intro-
duced the UK Conformity Assessed (UKCA) marking, replacing
the CE mark for devices placed on the market in England, Wales,
and Scotland. The Medical Devices Regulations 2002 (UK MDR
2002) are the current regulatory framework. As such, the UK
continues to follow the former European Directives: Directive
90/385/EEC on active implantable medical devices, Directive
93/42/EEC on medical devices, and Directive 98/79/EC on in
vitro diagnostic medical devices. Depending on the device type
and the directives they comply with, Great Britain continues to
recognize CE-marked devices until certain dates ranging from
2028 to 2030.69
Unlike Great Britain, Northern Ireland remains under the
EU regulations and follows EU MDR and EU IVDR. Devices in
Northern Ireland require CE marking, which must be performed
by an EU-recognized notified body. If a device is assessed by a
UK notified body, it will also bear the UKNI marking. The UKCA
marking will not be recognized in Northern Ireland.
Notified Bodies
Notified bodies in the UK are now known as approved bodies.
They are no longer able to provide CE marking for devices to be
sold in the EU. Instead, they can perform conformity assessments
to provide the UKCA marking.70
Asia
China
This section delves into the development journey of modern
medical device regulation in China, maintaining its unique
Chinese characteristics while drawing on international advanced
experiences. It covers the origins, the creation of regulations,
international exchanges and cooperation, and the publication and
implementation of the newly revised Regulations on Supervision
and Management of Medical Devices (referred to as “the Regula-
tions” in the rest of this chapter).71 Furthermore, it looks forward
to the future development directions of medical device regulation
in China.
Early Beginnings
Tracing back to the late 1980s, the pharmaceutical industry
management department at the time was the State Pharmaceu-
tical Administration of China. Authorized by the State Council,
the State Pharmaceutical Administration was responsible for the
unified management of the production and market circulation of
pharmaceuticals and medical devices. However, due to the diver-
sity of the professional fields involved in medical devices and the
relatively backward production level of medical devices in China
at that time, a unified industry had not yet formed. The production
and market management of medical devices in China were carried
out by different industrial management departments.
In the late 1980s, preparations were made to establish a
department to specifically implement a unified management
program for medical devices. From 1988 to 1996, the State
Pharmaceutical Administration sent medical device management
delegations to developed countries and regions such as the US,
Europe, Canada, Australia, and Japan multiple times yearly. These
delegations conducted investigations to understand the history,
system, models, technical means, and specific laws and regulations
of medical device regulation in these countries and regions.72
Evolution of Regulatory Framework
In 1990, the State Pharmaceutical Administration reported its
plan for medical device legislation to the State Council. It began
drafting China’s administrative regulations for medical device
supervision and management based on the organization and
summary of regulatory systems, regulations, and experiences of
developed countries.