IOF-TTO Event

17.10.2017

Regulation of software a medical device

Steve EglemResponsible of clinical investigation @ famhp

Member of the medical device European Clinical and Evaluation (CIE) working group

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• Famhp presentation

• European and Belgian legal framework on medical devices

• Legal reference

• Definitions & Examples

• Classification

• Software as medical device

• Validation process and conformity assessment

• Impact of MDR

• Impact of GDPR from medical device perspective

Content

Subject - DateFAMHP/entity/Division-Unit-Cell

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FAMHP - AFMPS – FAGG

http://www.fagg-afmps.be

• Address : Victor Horta Square 40/40

In front of the Midi Station

• More than 400 employees

• Minister of Public Health and Social

Affairs : Maggie De Block

• CEO : Xavier De Cuyper

Who are we?

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National competent autority in Belgium responsible for the quality, safety and efficacy of medicines and health products.

The famhp ensures, from development to use, the quality, safety and efficacy of medicines for human and veterinary use (including homeopathic medicines, herbal medicines, pharmacy made and officinal preparations) and also medical devices and accessories, and raw materials for the preparation and production of medicines.From collection to use, the fahmp ensures the quality, safety and efficacy of all the operations involving with blood, cells and tissues.

Our stakeholders :

FAMHP

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93/42 directive : MD

•NMR, US, X-ray,

•Hip-implants, ECG, EEG,

• Intravascular catheters, Stents, syringes, IOL, RR, med. lasers, med. software

90/385 directive : AIMD

•Pacemakers; ICD‘s

• Implantable Infusion pumps

•Artificial hearts ...

98/79 directive : IVD MD

•HIV-tests, Hepatitis-tests,

•Pregnancy-tests,

• Lab-Automats, Reagents, Calibrators, Control materials

•Prim. specimen receptacles ...

Transpositions

RD 18/03/1999 RD 15/07/1997 RD 14/11/2001

Legal framework

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93/42 directive : MD

•NMR, US, X-ray,

•Hip-implants, ECG, EEG,

• Intravascular catheters, Stents, syringes, IOL, RR, med. lasers, med. software

90/385 directive : AIMD

•Pacemakers; ICD‘s

• Implantable Infusion pumps

•Artificial hearts ...

98/79 directive : IVD MD

•HIV-tests, Hepatitis-tests,

•Pregnancy-tests,

• Lab-Automats, Reagents, Calibrators, Control materials

•Prim. specimen receptacles ...

Regulation 2017/745 Regulation 2017/746

Legal framework

Future

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‘medical device’ means any instrument, apparatus, appliance, software, material or

other article, whether used alone or in combination, including the software intended

by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes

and necessary for its proper application, intended by the manufacturer

to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or

handicap, investigation,

• replacement or modification of the anatomy or of a physiological process,

• control of conception,

and which does not achieve its principal intended action in or on the human body by

pharmacological, immunological or metabolic means, but which may be assisted in its

function by such means;

Legal framework

Definition

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MD

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'active medical device' means any medical device relying for its functioning on a

source of electrical energy or any source of power other than that directly

generated by the human body or gravity,

Stand alone software with a medical purpose is considered as an active

medical device

Legal framework –

Definition

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'active implantable medical device‘ (AIMD) means any active medical device

which is intended to be totally or partially introduced, surgically or medically, into

the human body or by medical intervention into a natural orifice , and which is

intended to remain after the procedure;

Legal framework –

Definition

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AIMD

Legal framework

Definition

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‘accessory’ means an article which whilst not being a device is

intended specifically by its manufacturer to be used together with

a device to enable it to be used in accordance with the use of the

device intended by the manufacturer of the device;

Legal framework

Definition

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Example :

Accessory of ECG machine : pads, paper.

Legal framework

Definition

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Example :

Accessory of medical contact lens : liquid to

wash/rince the lens

Legal framework

Definition

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Example :

Accessory of medical endoscope : screen monitors, cables,…

Legal framework

Definition

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Example :

Accessory of medical endoscope : disinfecting solution

Legal framework

Definition

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‘in vitro diagnostic medical device’ (IVD) means any medical device which is

a reagent, reagent product, calibrator, control material,

kit, instrument, apparatus, equipment or system, whether used alone or in

combination, intended by the manufacturer to be used

in vitro for the examination of specimens, including blood and tissue donations,

derived from the human body, solely or principally for the purpose of providing

information:

— concerning a physiological or pathological state, or

— concerning a congenital abnormality, or

— to determine the safety and compatibility with potential recipients,

or

— to monitor therapeutic measures.

Legal framework

Definition

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IVD

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MD

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Legal framework

Classification

From medtech Europe

Rules of classification based on the potential risks associated

with the technical design and manufacture of the devices

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Legal framework

Classification (from software perspective)

EU Directive MDR

No specific rules of classification (followactive medical devices)

Specific classification for software : • providing information which is used to

take decisions with diagnosis or therapeutic purposes (Class IIA/IIB/III)

• Intended to monitor physiological processes (Class IIB)

• Others (Class I)

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Legal framework

Software as medical device

• Could fall under IVD or MDD directive• Medical purpose (claim!)• Software does not perform an action on data, or performs an action

limited to storage, archival, communication, "simple search" or lossless compression.

• And if my app falls under a medical device framework?• It must comply with the safety and performance requirements

• Other obligations for manufacturers regard the issues of registration, post-market surveillance, incident reporting.

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Legal framework

Software as medical device

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Legal framework

Software as medical device

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• What does it mean?

• Demonstrate the safety and performance of the device.

• Performance : The ability of a medical device to achieve its intended purpose as

claimed by the manufacturer.

• Safety : The absence of unacceptable clinical risks, when using the device

according to the manufacturer’s Instructions for Use.

• Device fulfill essential requirements ?

• the information materials supplied by the manufacturer(the labelling, instructions for use, promotional materials, including accompanying documents foreseen by the manufacturer)

• the clinical evaluation (the device description used for the clinical evaluation, other contents of the clinical evaluation report)

• the available clinical data (such as results of Clinical Investigations, publications, PMS studies, etc.).

Validation process and conformityassessment

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Validation process and conformityassessment

Preclinical Data

•Scientific litterature

Similar product?

Check harmonized standards, what is needed?

Biocompatibility tested

Fatigue and resistance test

…

Clinical Data

•Scientific litterature

•Clinical Investigation

Sufficient clinical evidence?

•Performance (claim!)

•safety

Essential requirements

•Demonstration of conformity is now fulfilled?

Clinical Evaluation :

• From the beginning (development of the device)

• Mandatory for CE-marking

• Updated throughout all the life cycle of the device (pre and post market)

• Guide the clinical research (with the risk management; iso 14971

Build your risk analysisduring each step…

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Validation process and conformityassessment

Essential requirements (ER) in the current directive :Annex I – point 12. Requirements for medical devices connected to or equipped with an energy source :• repeatability, reliability and performance of these systems according to the

intended use• validated according to the state of the art taking into account the principles of

development lifecycle, risk management, validation and verification.• Monitor clinical parameters : alarm should be implemented• …• Cybersecurity not included in the current directive…

Standards for software which could provide more information on the ER that you need to fulfill and how to do it:

• IEC 62304 : medical software – software life-cycle processes• NBN 62366 : Medical devices - Application of usability engineering to medical

devices• NBN 82304 : Health Software - General requirements for product safety

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• Conformity procedure?

• Different routes following the MD classification…

• Such compliance must be assessed through a specific conformity

assessment procedure, which is proportional to the risk-class:

• For low-risk products (Class I), the manufacturer can provide a self-declaration

• For all other products (Classes IIa, IIb and III), a control must be done by a Notified Body

Validation process and conformityassessment

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• Conformity procedure?

Validation process and conformityassessment

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Impact of MDR

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The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:

• stricter control for high-risk devices

• the reinforcement of the criteria for designation and processes for oversight of Notified Bodies

• the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations (annex XVI)

• the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance

• improved transparency through an European database

Impact of MDR/IVDR

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• the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations

• the strengthening of post-market surveillance requirements for manufacturers

• improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

• Existing products will have to be reassessed under the new rules at latest may 2024

• New definitions

• Introduction of Common Specifications (CS): a set of technical and/or clinical requirements other than a standard, providing a means to comply with the legal obligations applicable to a device, process or system

Impact of MDR/IVDR

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• Article 110 of MDR: ”Member States shall apply Directive95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation”

• Directive 95/46/EC is replaced as from 25 May 2018 by Regulation 2016/679 (EU) of 27 April 2016 on the protection of natural persons with regard to the processing of personal data («GDPR»)

• Health-related data not defined in current Directive

• GDPR: “data concerning health” = Personal Data related to

• Physical or mental health

• Of a (identified or identifiable) natural person

• Including the provision of health care services

• Which reveals information about his/her health status

• Large definition

Impact on clinical investigation to collect clinical data…

Advice from ethic committee

Impact of GDPR

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Take home message…

Your claim, purpose, objective of yourapp

Apply the regulatory route

Possible medical device

Check it with EU guidance, ask to a competent autority…

Plan your clinical evaluation taking intoaccount the new regulation from now!

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Contact

Federal Agency for Medicines and Health Products –FAMHP

Place Victor Horta 40/40

1060 BRUXELLES

tel. + 32 2 528 40 00

fax + 32 2 528 40 01

e-mail welcome@fagg-afmps.be

www.afmps.be

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Tools

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Tools

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Tools

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Tools

Your medicines and health products,our concern