10 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
In addition, the EC publishes the agendas and minutes
of the Medical Device Coordinating Group (MDCG) and its
working groups.59
Economic Issues
Although public health protection is the primary driver of
healthcare regulation, economic considerations also began to
have an impact in the second half of the 20th century. With the
establishment of the first health insurance systems, the growing
availability and number of healthcare products increased costs for
Member States. The transfer of healthcare costs from individuals
to private or public insurance systems necessitated a product
pricing policy, confirming that limited economic resources had to
be spent prudently. This was aggravated by subsequent economic
crises. The pressure to limit public expenditure led to stringent
healthcare cost-cutting measures in several Member States.
Market access for medical products is controlled by EU
regulations, but pricing and reimbursement are national respon-
sibilities. This continues to be a sensitive area. Health technology
assessment (HTA) has been the standard method in the phar-
maceutical world for medical product reimbursement decisions
for a long time. HTA is, in principle, done at the national level
however, some EU-level documents are in place to encourage
and facilitate cooperation between national HTA organizations.
Regulation (EU) 2021/2282 of the European Parliament and of
the Council of 15 December 2021 on health technology assess-
ment and amending Directive 2011/24/EU entered into force on
1 January 2022.60 This new regulation contributes to improving
the availability of innovative health technologies for EU patients,
such as medicines and certain medical devices.61
Falsification and Counterfeiting
The increasing economic value of medical products has made
them attractive targets for falsification and counterfeiting, which
represents a growing threat to public health. The risk of detection
and prosecution is low compared to other criminal activities, and
potential financial gains are high. Internet sales contribute to the
problem. The World Health Organization (WHO) has found that
over 50% of medicines purchased on internet sites that conceal
their real addresses are counterfeit.62
Counterfeit medical devices are a problem, e.g., counterfeit
condoms, glucose test strips, and insulin needles have been seized
on the EU market.63
Regulators recognized the importance of fighting these crim-
inal activities in the interest of public health. In 2011, the Council
of Europe issued the Medicrime Convention.64 This international
convention makes any contribution to falsified medical products
a criminal offense and provides a framework for national and
international cooperation. Medicrime entered into force in 2016 in
those jurisdictions that have signed it.65
The EU MDR and EU IVDR introduced the unique de-
vice identification (UDI) system, designed to prevent falsified
devices, enhance postmarket safety-related activities, reduce
medical errors, and improve purchasing, waste disposal, and
stock-management policies.36,37
United Kingdom (UK)
The UK is a constitutional monarchy and parliamentary democ-
racy, where citizens elect representatives to the legislature, and all
governmental actions are performed in the name of the monarch.
As a unitary state with devolved governments, the UK’s central
government retains sovereignty but shares powers with the de-
volved administrations of Scotland, Wales, and Northern Ireland.
To ensure effective governance, the UK government is structured
into three branches—executive, legislative, and judicial. A basic
primer of the UK government system, while out of the scope of
this book, is useful in this context.66
The UK and the EU
Initially hesitant to join the earlier forms of European integra-
tion, the UK applied to join the European Economic Commu-
nity (EEC) in the 1960s but faced vetoes from France. The UK
successfully joined the EEC on 1 January 1973. This marked the
beginning of the UK’s formal economic relationship with Europe,
which deepened politically when the Maastricht Treaty trans-
formed the EEC into the European Union (EU) in 1993. While
the UK participated in the EU, it maintained certain opt-outs, re-
flecting its unique constitutional context and historically complex
relationship with broader European integration. This relationship
ended with the Brexit vote of 2016, leading to the UK’s official de-
parture from the EU in January 2020. This decision has impacted
its trade of medical devices with the EU.67
The Development of Medical Regulations
The formal regulation of medical devices in the UK began signifi-
cantly later than that of medicines, with regulatory frameworks
only established in the mid-1990s. However, the beginning of
medical device control in the UK dates to World War II, when
the Ministry of Supply created a medical equipment section to
encourage domestic production of previously imported items.
After the war, the expertise and insight gained from the Ministry
of Supply’s efforts were transferred to the Ministry of Health’s
Technical Services Group, tasked with inspecting and testing
medical equipment.68
The complexity and availability of medical devices kept
growing, and by the 1960s, recruitment of product specialists to
advise hospitals and develop standards and purchasing specifications
was necessary. In 1969, the UK Department of Health established
a defect and adverse incident reporting system and created the
Scientific and Technical Board (STB), which, along with a voluntary
quality assurance system, enhanced the safety and quality of medical
equipment by managing a medical device evaluation program whose
legacy continues today under the Medical Devices Agency (MDA).
These systems then evolved into the Manufacturer’s Registration
Scheme (MRS), registering 580 manufacturing sites globally before
being replaced by the Medical Device Directive 93/42 in 1998.
The Medical Devices Agency
In the 1980s, the STB was integrated into the National Health Ser-
vice (NHS) Procurement Directorate and later split into the NHS
Supplies Authority and the Medical Devices Directorate, becoming
Fundamentals of Medical Device Regulations: A Global Perspective
In addition, the EC publishes the agendas and minutes
of the Medical Device Coordinating Group (MDCG) and its
working groups.59
Economic Issues
Although public health protection is the primary driver of
healthcare regulation, economic considerations also began to
have an impact in the second half of the 20th century. With the
establishment of the first health insurance systems, the growing
availability and number of healthcare products increased costs for
Member States. The transfer of healthcare costs from individuals
to private or public insurance systems necessitated a product
pricing policy, confirming that limited economic resources had to
be spent prudently. This was aggravated by subsequent economic
crises. The pressure to limit public expenditure led to stringent
healthcare cost-cutting measures in several Member States.
Market access for medical products is controlled by EU
regulations, but pricing and reimbursement are national respon-
sibilities. This continues to be a sensitive area. Health technology
assessment (HTA) has been the standard method in the phar-
maceutical world for medical product reimbursement decisions
for a long time. HTA is, in principle, done at the national level
however, some EU-level documents are in place to encourage
and facilitate cooperation between national HTA organizations.
Regulation (EU) 2021/2282 of the European Parliament and of
the Council of 15 December 2021 on health technology assess-
ment and amending Directive 2011/24/EU entered into force on
1 January 2022.60 This new regulation contributes to improving
the availability of innovative health technologies for EU patients,
such as medicines and certain medical devices.61
Falsification and Counterfeiting
The increasing economic value of medical products has made
them attractive targets for falsification and counterfeiting, which
represents a growing threat to public health. The risk of detection
and prosecution is low compared to other criminal activities, and
potential financial gains are high. Internet sales contribute to the
problem. The World Health Organization (WHO) has found that
over 50% of medicines purchased on internet sites that conceal
their real addresses are counterfeit.62
Counterfeit medical devices are a problem, e.g., counterfeit
condoms, glucose test strips, and insulin needles have been seized
on the EU market.63
Regulators recognized the importance of fighting these crim-
inal activities in the interest of public health. In 2011, the Council
of Europe issued the Medicrime Convention.64 This international
convention makes any contribution to falsified medical products
a criminal offense and provides a framework for national and
international cooperation. Medicrime entered into force in 2016 in
those jurisdictions that have signed it.65
The EU MDR and EU IVDR introduced the unique de-
vice identification (UDI) system, designed to prevent falsified
devices, enhance postmarket safety-related activities, reduce
medical errors, and improve purchasing, waste disposal, and
stock-management policies.36,37
United Kingdom (UK)
The UK is a constitutional monarchy and parliamentary democ-
racy, where citizens elect representatives to the legislature, and all
governmental actions are performed in the name of the monarch.
As a unitary state with devolved governments, the UK’s central
government retains sovereignty but shares powers with the de-
volved administrations of Scotland, Wales, and Northern Ireland.
To ensure effective governance, the UK government is structured
into three branches—executive, legislative, and judicial. A basic
primer of the UK government system, while out of the scope of
this book, is useful in this context.66
The UK and the EU
Initially hesitant to join the earlier forms of European integra-
tion, the UK applied to join the European Economic Commu-
nity (EEC) in the 1960s but faced vetoes from France. The UK
successfully joined the EEC on 1 January 1973. This marked the
beginning of the UK’s formal economic relationship with Europe,
which deepened politically when the Maastricht Treaty trans-
formed the EEC into the European Union (EU) in 1993. While
the UK participated in the EU, it maintained certain opt-outs, re-
flecting its unique constitutional context and historically complex
relationship with broader European integration. This relationship
ended with the Brexit vote of 2016, leading to the UK’s official de-
parture from the EU in January 2020. This decision has impacted
its trade of medical devices with the EU.67
The Development of Medical Regulations
The formal regulation of medical devices in the UK began signifi-
cantly later than that of medicines, with regulatory frameworks
only established in the mid-1990s. However, the beginning of
medical device control in the UK dates to World War II, when
the Ministry of Supply created a medical equipment section to
encourage domestic production of previously imported items.
After the war, the expertise and insight gained from the Ministry
of Supply’s efforts were transferred to the Ministry of Health’s
Technical Services Group, tasked with inspecting and testing
medical equipment.68
The complexity and availability of medical devices kept
growing, and by the 1960s, recruitment of product specialists to
advise hospitals and develop standards and purchasing specifications
was necessary. In 1969, the UK Department of Health established
a defect and adverse incident reporting system and created the
Scientific and Technical Board (STB), which, along with a voluntary
quality assurance system, enhanced the safety and quality of medical
equipment by managing a medical device evaluation program whose
legacy continues today under the Medical Devices Agency (MDA).
These systems then evolved into the Manufacturer’s Registration
Scheme (MRS), registering 580 manufacturing sites globally before
being replaced by the Medical Device Directive 93/42 in 1998.
The Medical Devices Agency
In the 1980s, the STB was integrated into the National Health Ser-
vice (NHS) Procurement Directorate and later split into the NHS
Supplies Authority and the Medical Devices Directorate, becoming