8 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
The MDD (and, if applicable, the AIMDD and IVDD) were
amended by:
• Directive 2000/70/EC of the European Parliament and of
the Council of 16 November 2000 amending Council Di-
rective 93/42/EEC as regards medical devices incorporating
stable derivatives of human blood or human plasma,46 which
brought medical devices incorporating stable human blood
derivatives within the MDD’s scope
• Directive 2001/104/EC of the European Parliament and of
the Council of 7 December 2001 amending Council Direc-
tive 93/42/EEC concerning medical devices,47 which clarified
that stable human blood products as such (not incorporated
in a device) are not in the MDD’s scope
• Commission Directive 2003/12/EC of 3 February 2003 on
the reclassification of breast implants in the framework of
Directive 93/42/EEC concerning medical devices, 48 which
classified breast implants in risk Class III
• Commission Directive 2005/50/EC of 11 August 2005 on
the reclassification of hip, knee, and shoulder joint replace-
ments in the framework of Council Directive 93/42/EEC
concerning medical devices, 49 which up-classified hip, knee,
and shoulder implants from risk Class IIb to risk Class III
• Commission Regulation (EU) No 722/2012 of 8 August
2012 concerning particular requirements regarding the
requirements laid down in Council Directives 90/385/EEC
and 93/42/EEC with respect to active implantable medical
devices and medical devices manufactured utilizing tissues of
animal origin.50 The aim was to improve protection against
the overall risk of transmitting animal spongiform encepha-
lopathies (TSE/BSE) and
• Commission Regulation (EU) No 207/2012 of 9 March 2012
on electronic instructions for use of medical devices, which
allows instructions for use for some medical devices (e.g., for
professional use) to be delivered in electronic format.51
All the above legal changes impacted specific, isolated sections
of the MDD. The Commission was obligated to evaluate the
MDD’s overall functioning and effectiveness within five years of
its coming into force and report to the Council. This evaluation
exercise resulted in a proposal for an update to the AIMDD and
MDD in 2005, leading to adoption of Directive 2007/47/EC
of the European Parliament and Council of 5 September 2007
amending Council Directive 90/385/EEC on the approximation
of laws of Member States relating to active implantable medi-
cal devices, Council Directive 93/42/EEC concerning medical
devices, and Directive 98/8/EC concerning placing biocidal
products on the market.52
The AMDD and MDD revisions left the existing framework
untouched it was a technical revision. The main changes included
bringing software explicitly into the definition of a medical device,
adding obligatory checks of representative samples of Class IIa
and Class IIb device design dossiers by notified bodies to the qual-
ity system conformity assessment module (MDD Annex II), and
extending clinical evaluation obligations. These provisions came
into force in March 2010.
In 2008, the EC initiated the next revision by issuing a public
consultation. This revision’s timing raised questions. Most respon-
dents to the public consultation (in particular, Member States and
industry) considered a 2008 revision premature since the previous
revision by Directive 2007/47 was to take effect in March 2010.
Eventually, the EC published its proposal for a new medical device
regulation and a new in vitro diagnostic regulation in September
2012. The subsequent legislative procedure took more than four
years. It resulted in EU MDR, which maintains the New Ap-
proach requirements, including the role of notified bodies in the
certification of mid- and high-risk devices. However, these new
regulations include several extended and/or new requirements,
especially for clinical studies.
The requirements for notified bodies have also substantially
expanded. In addition, the designation process is no longer execut-
ed by one individual national authority but by a team of authori-
ties led by the EC. The designation process has taken much longer
than anticipated by authorities and notified bodies.
To ensure a smooth transition from the MDD to the EU
MDR, a so-called “soft transition” provision was included. Devices
with a valid certificate under the MDD could remain on the EU
market under certain conditions. First, Regulation 2020/561 of
the European Parliament and of the Council of 23 April 202053
postponed the date of application of certain EU MDR provisions
for one year until 26 May 2021, primarily due to the COVID-19
pandemic. Subsequent extensions in 2023 have revised the “soft
transition” timeline for certain medical devices.
Additional Discussions on In Vitro Diagnostics
Because of their specific nature, in vitro diagnostics were
regulated in a separate directive (IVDD). The IVDD came into
force in 1998. Its provisions became applicable to new IVDs in
2000 and to IVDs already on the market in compliance with
existing national legislation in 2003. IVDs are reagents, reagent
products, calibrators, control materials, kits, instruments, appa-
ratus, equipment, or systems used for the in vitro examination
of human samples to make a medical diagnosis. Blood and
tissue donations are also covered.
The IVDD followed the same format as the MDD but
with some differences. The IVDD includes special provisions for
self-testing devices (e.g., pregnancy tests) that require notified
body involvement. Additionally, tests and reagents developed in
health institutions’ laboratories do not have to comply with IVDD
provisions before being used to make a medical diagnosis if they
are used only within the same health institution and are not placed
on the market.
The most striking difference between IVDD and MDD
is the risk classification system. Unlike the MDD, IVDD risk
classification was not rule-based. IVDD Annex II included two
lists of diseases and biomarkers: List A and List B. If an IVD was
included in Annex II, a notified body’s intervention is required.
List A included reagents for determining blood groups, hepatitis,
and HIV. List B included a variety of reagents for infectious and
congenital diseases. Annex II’s content was considered state-of-
the-art healthcare in the early 1990s. Since it has not been updated
Fundamentals of Medical Device Regulations: A Global Perspective
The MDD (and, if applicable, the AIMDD and IVDD) were
amended by:
• Directive 2000/70/EC of the European Parliament and of
the Council of 16 November 2000 amending Council Di-
rective 93/42/EEC as regards medical devices incorporating
stable derivatives of human blood or human plasma,46 which
brought medical devices incorporating stable human blood
derivatives within the MDD’s scope
• Directive 2001/104/EC of the European Parliament and of
the Council of 7 December 2001 amending Council Direc-
tive 93/42/EEC concerning medical devices,47 which clarified
that stable human blood products as such (not incorporated
in a device) are not in the MDD’s scope
• Commission Directive 2003/12/EC of 3 February 2003 on
the reclassification of breast implants in the framework of
Directive 93/42/EEC concerning medical devices, 48 which
classified breast implants in risk Class III
• Commission Directive 2005/50/EC of 11 August 2005 on
the reclassification of hip, knee, and shoulder joint replace-
ments in the framework of Council Directive 93/42/EEC
concerning medical devices, 49 which up-classified hip, knee,
and shoulder implants from risk Class IIb to risk Class III
• Commission Regulation (EU) No 722/2012 of 8 August
2012 concerning particular requirements regarding the
requirements laid down in Council Directives 90/385/EEC
and 93/42/EEC with respect to active implantable medical
devices and medical devices manufactured utilizing tissues of
animal origin.50 The aim was to improve protection against
the overall risk of transmitting animal spongiform encepha-
lopathies (TSE/BSE) and
• Commission Regulation (EU) No 207/2012 of 9 March 2012
on electronic instructions for use of medical devices, which
allows instructions for use for some medical devices (e.g., for
professional use) to be delivered in electronic format.51
All the above legal changes impacted specific, isolated sections
of the MDD. The Commission was obligated to evaluate the
MDD’s overall functioning and effectiveness within five years of
its coming into force and report to the Council. This evaluation
exercise resulted in a proposal for an update to the AIMDD and
MDD in 2005, leading to adoption of Directive 2007/47/EC
of the European Parliament and Council of 5 September 2007
amending Council Directive 90/385/EEC on the approximation
of laws of Member States relating to active implantable medi-
cal devices, Council Directive 93/42/EEC concerning medical
devices, and Directive 98/8/EC concerning placing biocidal
products on the market.52
The AMDD and MDD revisions left the existing framework
untouched it was a technical revision. The main changes included
bringing software explicitly into the definition of a medical device,
adding obligatory checks of representative samples of Class IIa
and Class IIb device design dossiers by notified bodies to the qual-
ity system conformity assessment module (MDD Annex II), and
extending clinical evaluation obligations. These provisions came
into force in March 2010.
In 2008, the EC initiated the next revision by issuing a public
consultation. This revision’s timing raised questions. Most respon-
dents to the public consultation (in particular, Member States and
industry) considered a 2008 revision premature since the previous
revision by Directive 2007/47 was to take effect in March 2010.
Eventually, the EC published its proposal for a new medical device
regulation and a new in vitro diagnostic regulation in September
2012. The subsequent legislative procedure took more than four
years. It resulted in EU MDR, which maintains the New Ap-
proach requirements, including the role of notified bodies in the
certification of mid- and high-risk devices. However, these new
regulations include several extended and/or new requirements,
especially for clinical studies.
The requirements for notified bodies have also substantially
expanded. In addition, the designation process is no longer execut-
ed by one individual national authority but by a team of authori-
ties led by the EC. The designation process has taken much longer
than anticipated by authorities and notified bodies.
To ensure a smooth transition from the MDD to the EU
MDR, a so-called “soft transition” provision was included. Devices
with a valid certificate under the MDD could remain on the EU
market under certain conditions. First, Regulation 2020/561 of
the European Parliament and of the Council of 23 April 202053
postponed the date of application of certain EU MDR provisions
for one year until 26 May 2021, primarily due to the COVID-19
pandemic. Subsequent extensions in 2023 have revised the “soft
transition” timeline for certain medical devices.
Additional Discussions on In Vitro Diagnostics
Because of their specific nature, in vitro diagnostics were
regulated in a separate directive (IVDD). The IVDD came into
force in 1998. Its provisions became applicable to new IVDs in
2000 and to IVDs already on the market in compliance with
existing national legislation in 2003. IVDs are reagents, reagent
products, calibrators, control materials, kits, instruments, appa-
ratus, equipment, or systems used for the in vitro examination
of human samples to make a medical diagnosis. Blood and
tissue donations are also covered.
The IVDD followed the same format as the MDD but
with some differences. The IVDD includes special provisions for
self-testing devices (e.g., pregnancy tests) that require notified
body involvement. Additionally, tests and reagents developed in
health institutions’ laboratories do not have to comply with IVDD
provisions before being used to make a medical diagnosis if they
are used only within the same health institution and are not placed
on the market.
The most striking difference between IVDD and MDD
is the risk classification system. Unlike the MDD, IVDD risk
classification was not rule-based. IVDD Annex II included two
lists of diseases and biomarkers: List A and List B. If an IVD was
included in Annex II, a notified body’s intervention is required.
List A included reagents for determining blood groups, hepatitis,
and HIV. List B included a variety of reagents for infectious and
congenital diseases. Annex II’s content was considered state-of-
the-art healthcare in the early 1990s. Since it has not been updated