6 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
post-production of a product was presumed to be in conformity
with the essential requirements of the law.
In June 2016, citizens of the United Kingdom (UK) voted
by referendum to terminate the UK’s EU membership. After the
“Brexit” procedure was completed, as of 1 January 2021, the UK
is no longer part of the EU single market. The UK Medicines and
Healthcare product Regulatory Agency MHRA31 is developing
its own regulatory system for medical devices.
EU Legislation
While the EU does not have a central agency for medical devices as
it does for pharmaceuticals with the European Medicines Agency
(EMA), medical devices are overseen by the European Commis-
sion (EC) Directorate-General for Health and Food Safety (DG
SANTE).32 Under the EU New Approach Directives and recent
regulations, Member States officially designate third parties called
notified bodies to perform work on behalf of Member States. A
Member State informs the EC and the other Member States that
the notified body fulfills the relevant requirements and has been
designated for conformity assessment according to a directive or
regulation. Notified bodies and specific medicinal product code des-
ignations are listed on the New Approach Notified and Designated
Organisations (NANDO) Information System.33 Notified bodies
are charged with assessing a manufacturer’s compliance with the
applicable EU legislation in order for a manufacturer to affix the CE
mark on its product’s label – unless the manufacturer is allowed to
self-certify depending upon device classification.
The Treaty of Rome is the foundation of EU legislation it is
the primary legislation.28 Directives and regulations are second-
ary legislation. A directive obligates Member States to imple-
ment its provisions into national laws. A regulation is directly
applicable in all Member States and obligates Member States to
remove any conflicting provisions from their national legislation.
Other forms of secondary legislation are decisions (binding on
Member States or legal entities, e.g., legal persons or companies),
opinions, and recommendations.
Within the legislative structure, there are also official EU
guidance documents. Guidance documents interpreting the medi-
cal device and in vitro diagnostic directives are called MEDDEVs.
Since 2017, with the introduction of the EU Medical Device Reg-
ulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU
IVDR), the Medical Device Coordination Group (MDCG) has
issued interpretation and guidance documents. These non-binding
consensus documents interpret and explain the legal texts and
intend to help manufacturers and other stakeholders fulfill their
regulatory obligations. However, it is not unusual for notified
bodies to use these formal interpretation guidance documents as
de facto requirements.
Historic Factors in the Development of Medical
Product Regulations
Ethics is the foundation of healthcare regulations. Originally, the
main objective of healthcare regulations was to protect individuals
from unethical and unsafe human trials. The first European health-
care regulations concerned the ethical treatment of human subjects.
After World War II, the Allied Forces organized a series of
military tribunals in Nuremberg, Germany, to prosecute prominent
Nazi leaders who had participated in the Holocaust and other war
crimes. These trials, known as the Nuremberg Trials, also included
the Doctors’ Trials, which prosecuted Nazi physicians for conduct-
ing medical experiments on prisoners in concentration camps. As
a result of the Doctors’ Trials, a set of research ethics principles
for human medical experiments called the Nuremberg Code
was drafted in 1947.34 The Helsinki Declaration of 1964 further
developed the Nuremberg Code and tied it to the Declaration
of Geneva (1948), an internationally acknowledged statement of
physicians’ ethical responsibilities. Although the Helsinki Declara-
tion is not a formal law, it has profoundly influenced national laws
on clinical research worldwide, including in Europe.
After the Helsinki Declaration, laws were drafted to regulate
which products could be placed on the market, and the claims
manufacturers could make about them. Today, medical product
regulations target not only ethical, safety, efficacy, and perfor-
mance concerns but also economic issues, including increased
availability of information, continuing technological and product
innovations, market structure changes, and consumer protection.
Consequences of Unsafe Products
Safety incidents have been catalysts for medical product regu-
lations. The Poly Implant Prothèse (PIP) breast implant case is
notable in the European medical device regulatory realm.
In the PIP case, a French manufacturer used industrial-grade
– not medical-grade – silicon oil breast implants, resulting in a
higher prevalence and incidence of rupture than other silicone
implants.35 The scandal acted as a catalyst for medical device regula-
tion reform, leading to Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002
and Regulation (EC) No 1223/2009 and repealing Council Direc-
tives 90/385/EEC and 93/42/EEC – also known as EU MDR36 –
and Regulation (EU) 2017/746 of the European Parliament and of
the Council of 5 April 2017 on in vitro diagnostic medical devices
and repealing Directive 98/79/EC and Commission Decision
2010/227/EU – also known as EU IVDR. 37
Evolution of Current Regulations -Product
Legislation in the EU
The fundamental purpose of creating the EU was to create a single
European market. Harmonized product legislation is a prerequisite
to achieving this single market concept, and harmonized product
legislation implies harmonization of technical specifications. Med-
ical device regulation in the EU is based on this New Approach
product legislation.
The New Approach includes a fast legislative pathway with
defined content and structure. Its legal basis is Article 95 of the
EU Treaty, enabling EU institutions to adopt measures to promote
the internal market’s establishment and operations.
When Member States incorporate the New Approach
requirements, they may include additional provisions to apply
them more effectively. These harmonized directives limit public
Fundamentals of Medical Device Regulations: A Global Perspective
post-production of a product was presumed to be in conformity
with the essential requirements of the law.
In June 2016, citizens of the United Kingdom (UK) voted
by referendum to terminate the UK’s EU membership. After the
“Brexit” procedure was completed, as of 1 January 2021, the UK
is no longer part of the EU single market. The UK Medicines and
Healthcare product Regulatory Agency MHRA31 is developing
its own regulatory system for medical devices.
EU Legislation
While the EU does not have a central agency for medical devices as
it does for pharmaceuticals with the European Medicines Agency
(EMA), medical devices are overseen by the European Commis-
sion (EC) Directorate-General for Health and Food Safety (DG
SANTE).32 Under the EU New Approach Directives and recent
regulations, Member States officially designate third parties called
notified bodies to perform work on behalf of Member States. A
Member State informs the EC and the other Member States that
the notified body fulfills the relevant requirements and has been
designated for conformity assessment according to a directive or
regulation. Notified bodies and specific medicinal product code des-
ignations are listed on the New Approach Notified and Designated
Organisations (NANDO) Information System.33 Notified bodies
are charged with assessing a manufacturer’s compliance with the
applicable EU legislation in order for a manufacturer to affix the CE
mark on its product’s label – unless the manufacturer is allowed to
self-certify depending upon device classification.
The Treaty of Rome is the foundation of EU legislation it is
the primary legislation.28 Directives and regulations are second-
ary legislation. A directive obligates Member States to imple-
ment its provisions into national laws. A regulation is directly
applicable in all Member States and obligates Member States to
remove any conflicting provisions from their national legislation.
Other forms of secondary legislation are decisions (binding on
Member States or legal entities, e.g., legal persons or companies),
opinions, and recommendations.
Within the legislative structure, there are also official EU
guidance documents. Guidance documents interpreting the medi-
cal device and in vitro diagnostic directives are called MEDDEVs.
Since 2017, with the introduction of the EU Medical Device Reg-
ulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU
IVDR), the Medical Device Coordination Group (MDCG) has
issued interpretation and guidance documents. These non-binding
consensus documents interpret and explain the legal texts and
intend to help manufacturers and other stakeholders fulfill their
regulatory obligations. However, it is not unusual for notified
bodies to use these formal interpretation guidance documents as
de facto requirements.
Historic Factors in the Development of Medical
Product Regulations
Ethics is the foundation of healthcare regulations. Originally, the
main objective of healthcare regulations was to protect individuals
from unethical and unsafe human trials. The first European health-
care regulations concerned the ethical treatment of human subjects.
After World War II, the Allied Forces organized a series of
military tribunals in Nuremberg, Germany, to prosecute prominent
Nazi leaders who had participated in the Holocaust and other war
crimes. These trials, known as the Nuremberg Trials, also included
the Doctors’ Trials, which prosecuted Nazi physicians for conduct-
ing medical experiments on prisoners in concentration camps. As
a result of the Doctors’ Trials, a set of research ethics principles
for human medical experiments called the Nuremberg Code
was drafted in 1947.34 The Helsinki Declaration of 1964 further
developed the Nuremberg Code and tied it to the Declaration
of Geneva (1948), an internationally acknowledged statement of
physicians’ ethical responsibilities. Although the Helsinki Declara-
tion is not a formal law, it has profoundly influenced national laws
on clinical research worldwide, including in Europe.
After the Helsinki Declaration, laws were drafted to regulate
which products could be placed on the market, and the claims
manufacturers could make about them. Today, medical product
regulations target not only ethical, safety, efficacy, and perfor-
mance concerns but also economic issues, including increased
availability of information, continuing technological and product
innovations, market structure changes, and consumer protection.
Consequences of Unsafe Products
Safety incidents have been catalysts for medical product regu-
lations. The Poly Implant Prothèse (PIP) breast implant case is
notable in the European medical device regulatory realm.
In the PIP case, a French manufacturer used industrial-grade
– not medical-grade – silicon oil breast implants, resulting in a
higher prevalence and incidence of rupture than other silicone
implants.35 The scandal acted as a catalyst for medical device regula-
tion reform, leading to Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002
and Regulation (EC) No 1223/2009 and repealing Council Direc-
tives 90/385/EEC and 93/42/EEC – also known as EU MDR36 –
and Regulation (EU) 2017/746 of the European Parliament and of
the Council of 5 April 2017 on in vitro diagnostic medical devices
and repealing Directive 98/79/EC and Commission Decision
2010/227/EU – also known as EU IVDR. 37
Evolution of Current Regulations -Product
Legislation in the EU
The fundamental purpose of creating the EU was to create a single
European market. Harmonized product legislation is a prerequisite
to achieving this single market concept, and harmonized product
legislation implies harmonization of technical specifications. Med-
ical device regulation in the EU is based on this New Approach
product legislation.
The New Approach includes a fast legislative pathway with
defined content and structure. Its legal basis is Article 95 of the
EU Treaty, enabling EU institutions to adopt measures to promote
the internal market’s establishment and operations.
When Member States incorporate the New Approach
requirements, they may include additional provisions to apply
them more effectively. These harmonized directives limit public