9
CHAPTER 1:
Medical Devices: A History
since 1998, the Annex is outdated. Diagnostics for infectious
diseases emerging since 1998 (e.g., SARS, avian flu, Ebola, MRSA,
and COVID-19) were not included in Annex II, so no notified
body involvement was legally required. This is now addressed in
the new EU IVDR. The EU IVDR includes a major change in
the risk classification system, evolving from a list-based system, as
described above, to a rule-based system (Class A, B, C, and D). The
involvement of a notified body is needed for all Class B, C and D
devices, as well as sterile Class A IVDs. The different routes of as-
sessment according to the class of the IVD are described in Article
48 and Annexes IX, X, and XI of the EU IVDR.
This new classification system is analogous to the system
already used for medical devices. It also will result in a substantial
increase in notified body involvement. For example, for IVDs on
the market in the Netherlands, it was estimated that the percent-
age of IVDs with obligatory notified body involvement would rise
from 7% under the IVDD to 84% under the EU IVDR.
While the EU IVDR officially was effective in May 2022,
it too included a “soft transition” provision, allowing IVDs with
a valid certificate under the IVDD to remain on the EU market
under certain conditions through May 2024. In 2021, it became
apparent that more time would be needed for a smooth transition
from IVDD to EU IVDR. The transition periods for diagnostics to
comply with the regulation were extended in 2022 amid pres-
sure from industry and fears of a market collapse for diagnostics.
Regulation (EU) 2022/112 of the European Parliament and the
Council of 25 January 202254 introduced a staggered extension of
the transition periods for EU IVDR. They deferred the application
of conditions for in-house devices.
While the EU IVDR has been applicable since 26 May 2022,
the amendment allowed for its progressive rollout regarding in
vitro diagnostics covered by a certificate or a declaration of con-
formity issued under the previous IVD Directive 98/79/EC. The
EU extended the transition periods to 26 May 2025 for high-risk
IVDs, 26 May 2026 for moderate-risk IVDs, and 26 May 2027 for
lower-risk IVDs.
Additional “Soft-Transition” Extensions for EU
MDR and EU IVDR
On 15 March 2023, the European Union extended the transition
periods again with Regulation (EU) 2023/607 of the European
Parliament and of the Council of 15 March 2023, amending the
EU MDR and the EU IVDR.55
The EC said it wanted to give manufacturers more time, as
a significant number of IVDs on the market have not yet taken
the necessary steps to come into compliance. On 13 June 2024,
the EC finalized Regulation (EU) 2024/1860 of the Europe-
an Parliament and of the Council of 13 June 2024, amending
Regulations (EU) 2017/745 and (EU) 2017/746 as regards a
gradual roll-out of Eudamed, the obligation to inform in case
of interruption or discontinuation of supply, and transitional
provisions for certain in vitro diagnostic medical devices. Under
the regulation, high-risk class D diagnostics must undergo a
conformity assessment under EU IVDR by 31 December 2027,
while Class C, or high individual and/or moderate public health
risk devices, will have until 31 December 2028, and low-risk
Class A sterile and Class B devices will have until 31 Decem-
ber 2029. The regulation also provides for a partial rollout of
EUDAMED and requires manufacturers to report certain supply
chain interruptions.56
Product Innovation
Recent developments in nanotechnology, 3D printing, wearables,
diagnostics for new biomarkers, medical software applications,
and artificial intelligence (AI) did not exist when the EU medical
device regulatory system was designed. Technology evolves faster
than legislation to regulate it can be drafted. As a result, adequate
regulation may not exist for new and innovative technologies.
The EC, the Member States’ national competent authorities,
and the notified bodies all play a role in governing innovative
medical devices and IVDs. However, for innovative devices or
novel therapies, trying to obtain a central opinion in the EU
for the necessary evidence and market pathway, with so many
different and diverse governing bodies overseeing the market
entry – often presents quite a challenge for innovative develop-
ers/manufacturers.
Innovative product developers may benefit from the lack of
regulatory specificity. On the other hand, a lack of adequate regu-
lation might lead to uncertainty about which rules apply and the
conditions under which a product under development is allowed
on the EU market. This might hamper or delay the market entry
of innovative products for which a clear medical need exists.
Information Availability and Transparency
With the advent of social media and supported by the internet,
information on medical products is available almost immedi-
ately to virtually everyone. This information overload can no
longer be controlled by authorities or industry. For individuals
without a medical education, it can be very challenging to dis-
tinguish between reliable, trustworthy, and accurate information
from misinformation.
Maintaining public confidence in the healthcare system
is crucial. In the late 1990s, EMA began publishing scientific
information on medicinal products on the European market to
answer growing societal demands for information and transpar-
ency. Because the scientific information published on medicinal
products was difficult for the public to understand, EMA decid-
ed to introduce a public-friendly medicinal product summary for
pharmaceuticals on the EU market.
The next step on the transparency path came in 2001, with
the publication of technical reports (summaries) of scientific
committee meetings on EMA’s website. Today, EMA agendas,
meeting minutes, and highlights are published publicly.57
EU MDR and EU IVDR enhanced transparency related
to medical devices, chiefly by creating a European database on
medical devices (EUDAMED). Once the database is online,
manufacturers will be required to draft a summary of safety and
clinical performance (SSCP) for certain high-risk devices to be
published on EUDAMED. SSCPs need to be clearly drafted to
be understandable to the general public.58
CHAPTER 1:
Medical Devices: A History
since 1998, the Annex is outdated. Diagnostics for infectious
diseases emerging since 1998 (e.g., SARS, avian flu, Ebola, MRSA,
and COVID-19) were not included in Annex II, so no notified
body involvement was legally required. This is now addressed in
the new EU IVDR. The EU IVDR includes a major change in
the risk classification system, evolving from a list-based system, as
described above, to a rule-based system (Class A, B, C, and D). The
involvement of a notified body is needed for all Class B, C and D
devices, as well as sterile Class A IVDs. The different routes of as-
sessment according to the class of the IVD are described in Article
48 and Annexes IX, X, and XI of the EU IVDR.
This new classification system is analogous to the system
already used for medical devices. It also will result in a substantial
increase in notified body involvement. For example, for IVDs on
the market in the Netherlands, it was estimated that the percent-
age of IVDs with obligatory notified body involvement would rise
from 7% under the IVDD to 84% under the EU IVDR.
While the EU IVDR officially was effective in May 2022,
it too included a “soft transition” provision, allowing IVDs with
a valid certificate under the IVDD to remain on the EU market
under certain conditions through May 2024. In 2021, it became
apparent that more time would be needed for a smooth transition
from IVDD to EU IVDR. The transition periods for diagnostics to
comply with the regulation were extended in 2022 amid pres-
sure from industry and fears of a market collapse for diagnostics.
Regulation (EU) 2022/112 of the European Parliament and the
Council of 25 January 202254 introduced a staggered extension of
the transition periods for EU IVDR. They deferred the application
of conditions for in-house devices.
While the EU IVDR has been applicable since 26 May 2022,
the amendment allowed for its progressive rollout regarding in
vitro diagnostics covered by a certificate or a declaration of con-
formity issued under the previous IVD Directive 98/79/EC. The
EU extended the transition periods to 26 May 2025 for high-risk
IVDs, 26 May 2026 for moderate-risk IVDs, and 26 May 2027 for
lower-risk IVDs.
Additional “Soft-Transition” Extensions for EU
MDR and EU IVDR
On 15 March 2023, the European Union extended the transition
periods again with Regulation (EU) 2023/607 of the European
Parliament and of the Council of 15 March 2023, amending the
EU MDR and the EU IVDR.55
The EC said it wanted to give manufacturers more time, as
a significant number of IVDs on the market have not yet taken
the necessary steps to come into compliance. On 13 June 2024,
the EC finalized Regulation (EU) 2024/1860 of the Europe-
an Parliament and of the Council of 13 June 2024, amending
Regulations (EU) 2017/745 and (EU) 2017/746 as regards a
gradual roll-out of Eudamed, the obligation to inform in case
of interruption or discontinuation of supply, and transitional
provisions for certain in vitro diagnostic medical devices. Under
the regulation, high-risk class D diagnostics must undergo a
conformity assessment under EU IVDR by 31 December 2027,
while Class C, or high individual and/or moderate public health
risk devices, will have until 31 December 2028, and low-risk
Class A sterile and Class B devices will have until 31 Decem-
ber 2029. The regulation also provides for a partial rollout of
EUDAMED and requires manufacturers to report certain supply
chain interruptions.56
Product Innovation
Recent developments in nanotechnology, 3D printing, wearables,
diagnostics for new biomarkers, medical software applications,
and artificial intelligence (AI) did not exist when the EU medical
device regulatory system was designed. Technology evolves faster
than legislation to regulate it can be drafted. As a result, adequate
regulation may not exist for new and innovative technologies.
The EC, the Member States’ national competent authorities,
and the notified bodies all play a role in governing innovative
medical devices and IVDs. However, for innovative devices or
novel therapies, trying to obtain a central opinion in the EU
for the necessary evidence and market pathway, with so many
different and diverse governing bodies overseeing the market
entry – often presents quite a challenge for innovative develop-
ers/manufacturers.
Innovative product developers may benefit from the lack of
regulatory specificity. On the other hand, a lack of adequate regu-
lation might lead to uncertainty about which rules apply and the
conditions under which a product under development is allowed
on the EU market. This might hamper or delay the market entry
of innovative products for which a clear medical need exists.
Information Availability and Transparency
With the advent of social media and supported by the internet,
information on medical products is available almost immedi-
ately to virtually everyone. This information overload can no
longer be controlled by authorities or industry. For individuals
without a medical education, it can be very challenging to dis-
tinguish between reliable, trustworthy, and accurate information
from misinformation.
Maintaining public confidence in the healthcare system
is crucial. In the late 1990s, EMA began publishing scientific
information on medicinal products on the European market to
answer growing societal demands for information and transpar-
ency. Because the scientific information published on medicinal
products was difficult for the public to understand, EMA decid-
ed to introduce a public-friendly medicinal product summary for
pharmaceuticals on the EU market.
The next step on the transparency path came in 2001, with
the publication of technical reports (summaries) of scientific
committee meetings on EMA’s website. Today, EMA agendas,
meeting minutes, and highlights are published publicly.57
EU MDR and EU IVDR enhanced transparency related
to medical devices, chiefly by creating a European database on
medical devices (EUDAMED). Once the database is online,
manufacturers will be required to draft a summary of safety and
clinical performance (SSCP) for certain high-risk devices to be
published on EUDAMED. SSCPs need to be clearly drafted to
be understandable to the general public.58