ev_20240704_presentation European Union .pdf

Peter Bischoff-Everding
European Commission
Directorate-General for Health and Food Safety (DG SANTE)
Unit D.3 – Medical Devices
The EU Regulations on medical devices
and in vitro diagnostic medical devices
Information session for international regulators
and stakeholders
4 July 2024

1. Welcome and scene setter
2. State of play of implementation
• Regulation (EU) 2017/745 on medical devices (MDR)
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
3. Q&A
4. Demo of EUDAMED, UDI, EMDN
Agenda
Housekeeping rules
1. please indicate your
organisation and name
(„edit display name“)
2. please mute your
microphone, when you don‘t
speak;
3. use the ‚raise your hand‘
button, if you want to speak

• Regulation (EU) 2017/745 on medical devices (MDR)
• applicable since 26 May 2021, plus extra transitional period for ‚legacy devices‘
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
• applicable since 26 May 2022, plus extra transitional period for ‚legacy devices‘
Regulatory framework

Objectives
“robust, transparent, predictable and
sustainable regulatory framework […] which
ensures a high level of safety and health
whilst supporting innovation”
Achievements
49 MDR notified bodies (13 applications ongoing)
~8,000 MDR certificates issued
12 IVDR notified bodies (9 applications ongoing)
~900 IVDR certificates issued
Expert panels (hosted by EMA)
EU Reference Laboratories
EUDAMED modules (Actors, UDI/DEV, NB/Certificates) in use
Challenges
Limited capacity of notified bodies
Length and costs of conformity assessment
Stricter requirements (especially pre-market
clinical data)
Risk of shortages
Delay of EUDAMED
Remedies
More time to transition from MDD/AIMDD/IVDD to MDR and
IVDR (i.e. extension of MDR and IVDR transitional periods)
No lowering of quality and safety requirements
MDCG guidance supporting the transition
Growing number of “harmonised standards” and extended
standardisation mandate
EU4Health Program projects

• Regulation (EU) 2023/607 of 15 March 2023 as regards the transitional
provisions for certain medical devices and in vitro diagnostic medical devices
Extension of MDR transitional period

Scope (“legacy devices”)
 Devices covered by MDD/AIMDD certificate issued by NB before 26 May 2021
 Devices requiring NB involvement for the first time under MDR with MDD Declaration of
Conformity drawn up before 26 May 2021 (“MDD self-declared devices”)
Staggered timelines depending on risk class
 31 December 2027 (class III and class IIb implantable, if not excepted, e.g. sutures etc.)
 31 December 2028 (other class IIb, class IIa, class I m/s, devices requiring NB involvement for
the first time under MDR)
MDR
classification
rules

Conditions for extension
 Continuous compliance with MDD/AIMDD
 No significant change in design/intended purpose
 No unacceptable risk to health/safety
 MDR QMS in place from 26 May 2024
 Application for conformity assessment of (substitute) device lodged by 26 May 2024
 Contract MF-NB signed by 26 September 2024
Extension of validity of MDD/AIMDD certificates (if above conditions are fulfilled)
 All MDD/AIMDD certificates valid on 20 March 2023 and not withdrawn
 Beyond original expiry date until end of transitional period (no update of date on certificate)
 Also certain certificates that had expired before 20 March 2023, if
 Contract MF-NB for conformity assessment signed before expiry of certificate or
 Device allowed on the market based on national measures

Surveillance by notified bodies during transitional period
 no later than 26 September 2024 by MDR notified body
 concerns only devices covered by a certificate
Temporary derogation for class III custom-made implantable devices
 MDR QMS certificate required only from 26 May 2026
Removal of ‘sell-off' dates in MDR and IVDR
 devices placed on the market before or during the (extended) transitional period and still in
supply chain can be further made available

Effects on manufacturers and devices
 ‘Legacy devices’ can be placed on EU market until 31 Dec. 2027/2028 (according to risk
class)
 Also after MDR certification of the device (unless MDD/AIMDD certificate is withdrawn)
 High level of safety
 PMS/Vigilance requirements of MDR apply since 26 May 2021
 Surveillance by notified bodies

Documents confirming that device is
covered by extended transitional period
 Manufacturer’s Declaration
 Common template (see EU Commission
website and Q&A)
 Details on MF, legacy devices, certificates,
validity date, MDR Notified Body etc.
 Notified Body Confirmation Letter (optional)
 Common template by NBCG-Med (see EU
Commission website and Q&A)
 List of devices covered by the extension
 Free Sale Certificate
 by National Competent
Authorities

Extended MDR transitional period
Entry into force
Regulation (EU)
2023/607
20
March
2023
SDF SDF SDF SDF SDF
Deadline to lodge
an application &
to have in place
an MDR QMS
26 May
2024
Deadline to sign a
written agreement &
transfer appropriate
surveillance to an
MDR NB
26 Sept
2024
End of derogation
for class III
custom-made
implantable
26 May
2026
End of transitional
period for class III
and class IIb
implantable (if not
exempted)
31 Dec
2027
End of transitional
period for other
class IIb, IIa, Is/m
and MD with no NB
involvement under
MDD
31 Dec
2028
30.4.2024:
>23,500
applications

mdr_proposal_extension-q-n-a.pdf (europa.eu) md_devices-art120_flowchart_0.pdf (europa.eu) MDR-IVDR_FS_third-countries_en (europa.eu)

 MDCG 2022-14: Transition to the MDR and IVDR - Notified body capacity and availability of medical devices
and IVDs (August 2022)
 MDCG 2020-3 Rev.1: Guidance on significant changes regarding the transitional provision under Article 120 of
the MDR with regard to devices covered by certificates according to MDD or AIMDD (Sept. 2023)
 MDCG 2022-6: Guidance on significant changes regarding the transitional provision under Article 110(3) of the
IVDR (May 2022)
 MDCG 2022-4 Rev.2: Guidance on appropriate surveillance regarding the transitional provisions under Article
120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD (May
2024)
 MDCG 2022-15: Guidance on appropriate surveillance regarding the transitional provisions under Article 110
of the IVDR with regard to devices covered by certificates according to the IVDD (September 2022)
 MDCG 2021-25: Application of MDR requirements to "legacy devices" and to devices placed on the market
prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (October 2021) under revision
 MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to
devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (May 2022)
 MDCG 2024-10: Guidance on clinical evaluation of orphan medical devices (June 2024) new!
 ....
MDCG guidance documents supporting the transition

Upcoming MDR/IVDR amendment
Ensure availability
especially of high-risk in
vitro diagnostics (IVDs)
by extending transition
periods
1
Provide healthcare
systems more time to
safeguard patient care
by introducing advance
warning of interruption
or discontinuation of
supply of certain
medical devices / IVDs
2
Enhance transparency
by enabling a gradual
roll-out of the European
Database on Medical
Devices (EUDAMED)
3
Regulation (EU) 2024/… of 13 June 2024 amending MDR and IVDR 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 (9 July 2024 expected publication in the OJEU)

Scope
 Devices covered by IVDD certificate issued by NB before 26 May 2022
 Devices requiring NB involvement for the first time under IVDR with IVDD Declaration of
Conformity drawn up before 26 May 2022 (“IVDD self-declared devices”)
Staggered timelines depending on risk class
 31 December 2027 (devices covered by IVDD certificate and class D devices)
 31 December 2028 (class C devices)
 31 December 2029 (class B and class A sterile devices)
Extension of IVDR transitional period

Conditions for extension
 Continuous compliance with IVDD
 No significant change in design/intended purpose
 No unacceptable risk to health/safety
 IVDR QMS in place from 26 May 2025
 Application for conformity assessment of (substitute) device lodged
 by 26 May 2025, for devices covered by IVDD certificate and class D devices
 by 26 May 2026, for class C devices
 by 26 May 2027, for class B and class A sterile devices
 Contract MF-NB signed
 by 26 September 2025, for devices covered by IVDD certificate and class D devices
 by 26 September 2026, for class C devices
 by 26 September 2027, for class B and class A sterile devices

Extension of validity of IVDD certificates (if above conditions are fulfilled)
 All IVDD certificates valid on 9 July 2024 (tbc) and not withdrawn
 Beyond original expiry date until end of transitional period (no update of date on certificate)
 Also certain certificates that had expired before 9 July 2024 (tbc), if
 Contract MF-NB for conformity assessment signed before expiry of certificate or
 Device allowed on the market based on national measures
Surveillance by notified bodies during transitional period
 by IVDR notified body at the latest from the date when contract MF-NB must be signed (i.e. 26
September 2025/2026/2027);
 concerns only devices covered by a certificate

Effects on manufacturers and devices
 ‘Legacy devices’ can be placed on EU market until 31 Dec. 2027/2028/2029 (according to
risk class)
 Also after IVDR certification of the device (unless IVDD certificate is withdrawn)
 High level of safety
 PMS/Vigilance requirements of IVDR apply since 26 May 2022
 Surveillance by notified bodies

Documents confirming that device is covered by
extended transitional period (same as for MDR)
 Manufacturer’s Declaration
 Common template
 Details on MF, legacy devices, certificates, validity
date, MDR Notified Body etc.
 Notified Body Confirmation Letter (optional)
 Common template by NBCG-Med
 List of devices covered by the extension
 Free Sale Certificate
 by National Competent Authorities
Coming soon

IVDR – Transitional periods
Time
26 May 2025 26 May 2026 26 May 2027
26 Sep 2025 26 Sep 2026 26 Sep 2027
31 Dec 2027 31 Dec 2028 31 Dec 2029
IVDD certified & class D
applications
written agreements
class C
applications
class C
written agreements
class B+A sterile
applications
class B+A sterile
written agreements
end of transition
class C end of
transition
class B+A sterile
end of transition
end of validity
IVDD certificates
31 Dec 2030
Equivalence condition
for in-house IVDs
Manufacturers of
all device risk
classes must
have IVDR QMS

21
Prior information about discontinuation or interruption of
supply (new Article 10a MDR/IVDR)
• Who?
• Manufacturers
• What?
• Discontinuation or interruption of supply of MD or IVD
• Risk of serious harm to patients or public health
• When?
• 6 months in advance
• To whom?
• NCA where manufacturer/AR is established (+information exchange between
NCAs)
• Economic operators (e.g. importer, distributor) or hospitals/healthcare
professionals
Q&A
work in
progress

Vigilance and
Post-market Surveillance
Market Surveillance
Clinical Investigations/Performance Studies
UDI Database
NB &
Certificates
EUDAMED public website
1
2
3
4
6
5
Actors
IT
development
in progress
Gradual roll-out of EUDAMED
Device

Enables mandatory use of a EUDAMED module 6 months after publication of EC
notice confirming module’s functionality
One registration throughout EU
Additional time for MF and NB to migrate device data and certificate information for
certain devices from national databases to EUDAMED
Coordinated assessment of applications for clinical investigations or performance
studies only when EUDAMED CI/PS module will become mandatory
Gradual roll-out of EUDAMED

Targeted evaluation of MDR/IVDR
• Assessment of underlying causes of remaining challenges
• Availability of devices needed for patient care
• Costs, predictability and administrative burden, especially for SME
• Governance
• Innovation in EU
Early and targeted evaluation of MDR/IVDR

Targeted evaluation of MDR/IVDR - timeline
Additional data
collection
and analysis
Call for
evidence
& public
consultation
Evaluation
report
Q4 2025
Q4 2023 Q1 2024 Q2 2024 Q3 2024 2024/2025
Internal preparations
EU rules on medical devices and in vitro diagnostics – targeted evaluation (europa.eu)

Thank you!
© European Union 2024
Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are
not owned by the EU, permission may need to be sought directly from the respective right holders.
Relevant contacts:
Websites:
• European Commission
• Directorate-General for Health and Food
Safety (DG SANTE)
• Unit D.3 Medical Devices
Email address:
• SANTE-MED-DEV[at]ec.europa.eu
• SANTE-MD-
INTERNATIONAL[at]ec.europa.eu

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