FOCUSING ON CHANGES IN PRODUCT

CLASSIFICATION UNDER MDR AND IVDR

Alex DenoonErik Vollebregt www.aelslf.e

u25 May 2016

Summary• MDR: some changes• IVDR: everything changes

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)

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.

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.

MDR reclassificationNew 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.

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.

IVDR reclassification• Impact everywhere with

completely new classification logic in Annex VII

IVDR reclassification

IVDR reclassification• Annex VII IVDR similar structure as

MDR– implementing rules– classification rules

IVDR reclassificationInteresting 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.

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?

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

Timeline MDR

Q3/4 2016Adoption of MDR

Q1/Q2 2017Entry into force

Q1/Q2 2020End of transition period MDR

Q1/Q2 2022Last possible granted MDD certificate expiresBest current

prediction of transitional regime

14

Certs grace period ?

Notified Bodies reaccreditation under MDR

Transition period of 3 years with

Sunshine

Timeline IVDR

Q3/4 2017Adoption of IVDR

Q1/Q2 2017Entry into force

Q1/Q2 2022End of transition period

Q1/Q2 2024Last 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

Dedicated to Life Sciences

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