7
CHAPTER 1:
Medical Devices: A History
authority intervention and enable industry to meet its obligations
in a manner suitable to the specific situation or device, without the
need for a cumbersome regulatory approval process. The decreased
regulatory burden for industry and public authorities has enabled
approval processes to advance much more quickly.
An essential feature of the New Approach is distinguishing
between the essential requirements for safety and performance
and the technical requirements. The essential requirements are
included in the legal texts (such as in Annex I of the medical
devices directive [Council Directive 93/42/EEC of 14 June
1993]) concerning medical devices. Technical specifications and
requirements are described in the standards. Standards can be
drafted on an international (ISO), regional (EN), or national
level. In principle, any company or individual interested in a par-
ticular standard is welcome to participate in the drafting process.
In practice, most participants in standardization processes come
from industry, but public authorities, academia, and patients’
representatives are also involved.
After a standard has been drafted and approved by a rec-
ognized standardization body on the international, regional, or
national level, it must be harmonized before it can be used in
the context of the New Approach Directives. The harmonization
process was described in Council Directive 83/189/EEC of 28
March 1983, which laid down a procedure for providing informa-
tion on technical standards and regulations.38 In addition, Directive
98/34/EC of the European Parliament and of the Council of 22
June 199839 laid down a procedure for the provision of information
in the field of technical standards and regulations and of rules in
information society services and Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012.40
Harmonization is achieved by approving a standard suitable to
provide a “presumption of conformity.” Presumption of conformity
means that if a product fulfills a harmonized standard’s require-
ments, the Member States presume the product to be in conformity
with the essential requirements. The EC publishes updates to the
list of harmonized standards in the Official Journal regularly.
A guide to the implementation of directives based on the New
Approach from 2000, called the Blue Guide after its blue cover, gives
a detailed description of how standards are to be utilized within the
New Approach Directives.41 The EU Commission published new
versions of the Blue Guide in 2014, 2016, and 2022.42
Harmonized EU Medical Device Directives
EU regulations relating to medical device safety and performance
were up to individual Member States until the 1990s, when they
were finally harmonized within the EU, following the New Ap-
proach legislative principles.
The core legal framework consisted of the following three
directives:
• Council Directive 90/385/ EEC of 20 June 1990 on the ap-
proximation of the laws of the Member States relating to active
implantable medical devices (AIMDD) 43
• Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (MDD) and44
• Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices (IVDD) 45
European legislators in the mid-1980s wanted the regulation har-
monization process to start with medical devices with the highest
public health risks, e.g., pacemakers and other active implantable
devices, followed by a series of other categorical medical device
directives (e.g., orthopedic implants, medical imaging) until the
whole spectrum of medical devices was covered. This plan was later
abolished, as legislators realized such a stepwise harmonization
process would take decades to complete. The decision to cover all
medical devices by one general medical device directive was a ma-
jor achievement, having regulated such a large and diverse group of
products successfully in one directive. More than 100,000 different
medical devices were on the market in Europe at that time, and
these were regulated by 60 pages of legal text.
Because of their specific characteristics, only in vitro diag-
nostics (IVDs) were covered by a separate directive (IVDs are not
applied to humans but to human specimens).
The AIMDD, MDD, and IVDD were introduced in line
with the New Approach. The manufacturer could choose among
the various conformity assessment procedure routes defined in
these directives. The device’s classification determined the routes
from which a manufacturer could choose. The classification rules
were based on the human body’s vulnerability and considered po-
tential risks associated with the device’s technical design and man-
ufacture. This classification system comprised 18 rules in principle,
each medical device risk class could be assigned by applying these
rules. There are four risk classes for Medical Devices: Class I for
low-risk, Class IIa and Class IIb for medium-risk, and Class III
for high-risk devices. There was a special Annex (Annex VII) on
risk classification. Medium- and high-risk class devices required a
design and manufacturing inspection by a notified body.
The IVDD distinguished four groups based on the risk asso-
ciated with using the respective products: List A, List B, Devices
for Self-Testing, and Other IVD Products. All products in List
A and List B require the participation of a notified body in all
aspects of the conformity assessment procedure.
For medical devices falling within the scope of other EU
regulations, e.g., the Low Voltage Directive and Electromagnetic
Compatibility (EMC) Directive for electrical medical equipment
and the EURATOM Directive for ionizing radiation-emitting
medical imaging equipment, the relevant requirements of other
applicable regulations had to be fulfilled before the manufacturer
was allowed to include the CE mark on its product and place the
product on the EU market.
Further Development of the EU Medical Device
Regulatory System
The MDD was introduced in 1993, and its provisions had to be
fully implemented in 1998. Stakeholders (Member States, EU
institutions, industry, notified bodies, etc.) undertook major efforts
to implement the new directives during the transition period,
but, in general, stakeholders thought this harmonized regulatory
system functioned effectively.
CHAPTER 1:
Medical Devices: A History
authority intervention and enable industry to meet its obligations
in a manner suitable to the specific situation or device, without the
need for a cumbersome regulatory approval process. The decreased
regulatory burden for industry and public authorities has enabled
approval processes to advance much more quickly.
An essential feature of the New Approach is distinguishing
between the essential requirements for safety and performance
and the technical requirements. The essential requirements are
included in the legal texts (such as in Annex I of the medical
devices directive [Council Directive 93/42/EEC of 14 June
1993]) concerning medical devices. Technical specifications and
requirements are described in the standards. Standards can be
drafted on an international (ISO), regional (EN), or national
level. In principle, any company or individual interested in a par-
ticular standard is welcome to participate in the drafting process.
In practice, most participants in standardization processes come
from industry, but public authorities, academia, and patients’
representatives are also involved.
After a standard has been drafted and approved by a rec-
ognized standardization body on the international, regional, or
national level, it must be harmonized before it can be used in
the context of the New Approach Directives. The harmonization
process was described in Council Directive 83/189/EEC of 28
March 1983, which laid down a procedure for providing informa-
tion on technical standards and regulations.38 In addition, Directive
98/34/EC of the European Parliament and of the Council of 22
June 199839 laid down a procedure for the provision of information
in the field of technical standards and regulations and of rules in
information society services and Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012.40
Harmonization is achieved by approving a standard suitable to
provide a “presumption of conformity.” Presumption of conformity
means that if a product fulfills a harmonized standard’s require-
ments, the Member States presume the product to be in conformity
with the essential requirements. The EC publishes updates to the
list of harmonized standards in the Official Journal regularly.
A guide to the implementation of directives based on the New
Approach from 2000, called the Blue Guide after its blue cover, gives
a detailed description of how standards are to be utilized within the
New Approach Directives.41 The EU Commission published new
versions of the Blue Guide in 2014, 2016, and 2022.42
Harmonized EU Medical Device Directives
EU regulations relating to medical device safety and performance
were up to individual Member States until the 1990s, when they
were finally harmonized within the EU, following the New Ap-
proach legislative principles.
The core legal framework consisted of the following three
directives:
• Council Directive 90/385/ EEC of 20 June 1990 on the ap-
proximation of the laws of the Member States relating to active
implantable medical devices (AIMDD) 43
• Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (MDD) and44
• Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices (IVDD) 45
European legislators in the mid-1980s wanted the regulation har-
monization process to start with medical devices with the highest
public health risks, e.g., pacemakers and other active implantable
devices, followed by a series of other categorical medical device
directives (e.g., orthopedic implants, medical imaging) until the
whole spectrum of medical devices was covered. This plan was later
abolished, as legislators realized such a stepwise harmonization
process would take decades to complete. The decision to cover all
medical devices by one general medical device directive was a ma-
jor achievement, having regulated such a large and diverse group of
products successfully in one directive. More than 100,000 different
medical devices were on the market in Europe at that time, and
these were regulated by 60 pages of legal text.
Because of their specific characteristics, only in vitro diag-
nostics (IVDs) were covered by a separate directive (IVDs are not
applied to humans but to human specimens).
The AIMDD, MDD, and IVDD were introduced in line
with the New Approach. The manufacturer could choose among
the various conformity assessment procedure routes defined in
these directives. The device’s classification determined the routes
from which a manufacturer could choose. The classification rules
were based on the human body’s vulnerability and considered po-
tential risks associated with the device’s technical design and man-
ufacture. This classification system comprised 18 rules in principle,
each medical device risk class could be assigned by applying these
rules. There are four risk classes for Medical Devices: Class I for
low-risk, Class IIa and Class IIb for medium-risk, and Class III
for high-risk devices. There was a special Annex (Annex VII) on
risk classification. Medium- and high-risk class devices required a
design and manufacturing inspection by a notified body.
The IVDD distinguished four groups based on the risk asso-
ciated with using the respective products: List A, List B, Devices
for Self-Testing, and Other IVD Products. All products in List
A and List B require the participation of a notified body in all
aspects of the conformity assessment procedure.
For medical devices falling within the scope of other EU
regulations, e.g., the Low Voltage Directive and Electromagnetic
Compatibility (EMC) Directive for electrical medical equipment
and the EURATOM Directive for ionizing radiation-emitting
medical imaging equipment, the relevant requirements of other
applicable regulations had to be fulfilled before the manufacturer
was allowed to include the CE mark on its product and place the
product on the EU market.
Further Development of the EU Medical Device
Regulatory System
The MDD was introduced in 1993, and its provisions had to be
fully implemented in 1998. Stakeholders (Member States, EU
institutions, industry, notified bodies, etc.) undertook major efforts
to implement the new directives during the transition period,
but, in general, stakeholders thought this harmonized regulatory
system functioned effectively.