Presentation at the Q1 Intensive MDR/IVDR Readiness and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation

1. FOCUSING ON CHANGES
IN PRODUCT
CLASSIFICATION UNDER
MDR AND IVDR
Alex Denoon
Erik Vollebregt www.aelslf.eu25 May 2016

2. Summary
• MDR: some changes
• IVDR: everything changes

3. MDR reclassification
• Main impact in
– class II implants (class III if they come into
contact with the spinal column (rule 8))
– substance based medical devices ((class IIb
default, class IIa in case on skin, class III if
systematically absorbed)
– software (is no longer an active device)

4. MDR reclassification
• Amended stuff in Annex VII
– Implementing rule 7. A device is considered to allow direct diagnosis
when it provides the diagnosis of the disease or condition by itself or
when it provides decisive information for the diagnosis.
– Rule 3: non-invasive devices consisting of a substance or a mixture of
substances intended to be used in vitro in direct contact with human
cells, tissues or organs taken off from the human body or with human
embryos before their implantation or administration into the body
– Rule 8 (long term surgically invasive and implantables) – IIb unless:
• active implantable medical devices or their accessories implantable accessories to
active implantable medical devices, in which case they are in class III,
• breast implants, in which case they are in class III;
• hip, knee or shoulder total and partial joint replacements, in which case they are in class
III, with the exception of ancillary components such as screws, wedges, plates and
instruments,
• spinal disc replacement implants and implantable devices that come into contact with
the spinal column, in which case they are in class III with the exception of components
such as screws, wedges, plates and instruments.

5. MDR reclassification
• Rule 9: active devices
– All active devices intended to emit ionizing radiation for therapeutic
purposes, including devices which control or monitor such devices, or
which directly influence their performance, are in class IIb.
– All active devices that are intended for controlling, monitoring or directly
influencing the performance of active implantable medical devices are in
class III.
• Rule 17: All devices manufactured utilising incorporating or
consisting of tissues or cells of human or animal origin, or their
derivatives, which are non-viable or rendered non-viable are in class
III, unless such devices are manufactured utilising tissues or cells of
animal origin, or their derivatives, which are non-viable or rendered
non-viable that are intended to come into contact with intact skin
only.

6. MDR reclassification
New stuff:
• Rule 19: All devices incorporating or consisting of nanomaterial are
in class III unless the nanomaterial is encapsulated or bound in such
a manner that it cannot be released into the patient’s or user's body
when the device is used within its intended purpose.
• Rule 21: Devices that are composed of substances or combinations
of substances that are intended to be ingested, inhaled or
administered rectally or vaginally introduced into the human body
via a body orifice, or applied on skin and that are absorbed by or
locally dispersed in the human body are:
– in class III if they, or their products of metabolism, are systemically
absorbed by the human body in order to achieve the intended purpose,
– in class III if they are intended to be introduced into the gastrointestinal
tract and they, or their products of metabolism, are systemically
absorbed by the human body,
– in class IIb in all other cases, except if they are applied on skin, in which
case they are in class IIa.

7. MDR reclassification
• Rule 22: All invasive devices with respect to body
orifices, other than surgically invasive devices, which are
intended to administer medicinal products by inhalation
are in class IIa, unless their mode of action has an
essential impact on the efficacy and safety of the
administered medicinal product and those that are
intended to treat life threatening conditions, in which
case they are in class IIb.
• Rule 23: Active therapeutic devices with an integrated or
incorporated diagnostic function, which significantly
determinates the patient management by the device are
in class III, such as closed loop systems or automated
external defibrillators.

8. IVDR reclassification
• Impact everywhere with completely
new classification logic in Annex VII

9. IVDR reclassification

10. IVDR reclassification
• Annex VII IVDR similar structure as MDR
– implementing rules
– classification rules

11. IVDR reclassification
Interesting implementing rules (rest similar to MDR)
• 1.5. Calibrators intended to be used with a device shall
be classified in the same class as the device.
• 1.6. Control materials with quantitative or qualitative
assigned values intended for one specific analyte or
multiple analytes shall be classified in the same class as
the device.
• 1.10. Each of the rules applies to first line assays,
confirmatory assays and supplemental assays.

12. What should a company do?
• Gap analysis
– which of my devices change class?
– how does this affect the conformity
assessment procedure(s) available?
– what extra clinical evidence is needed?
– any additional essential requirements that
apply or have changed?

13. What should a company do?
• Transition plan
– How and when do I generate additional
clinical evidence?
– Update of tech files and DoCs
– How do I plan re-certification by notified
body?
• IVDR: 80% of IVDs will require notified body as
opposed to 20% now

14. Timeline MDR
Q3/4
2016
Adoption
of MDR
Q1/Q2
2017
Entry into
force
Q1/Q2
2020
End of
transition
period
MDR
Q1/Q2 2022
Last
possible
granted
MDD
certificate
expires
Best current
prediction of
transitional regime
14
Certs
grace
period
Notified Bodies
reaccreditation
under MDR
Transition period of 3
years with Sunshine

15. Timeline IVDR
Q3/4
2017
Adoption
of IVDR
Q1/Q2
2017
Entry into
force
Q1/Q2
2022
End of
transition
period
Q1/Q2 2024
Last
possible
granted
IVDD
certificate
expires
Transition period of 5
years with Sunshine
Best current prediction of transitional regime
Certs
grace
period
Notified Bodies
reaccreditation
under IVDR

16. Dedicated to Life Sciences
Axon Lawyers Amsterdam
Italy Legal Focus Milan
Denoon Legal London
LCH Avocats Paris
Lützeler Klümper Düsseldorf Hamburg
Dewallens & partners Brussels Leuven
www.aelslf.eu