Matériaux médicaux implantables : le point aujourd’hui par Vanessa Binamé | Liege Creative,...

Parole d’expert

Christian GRANDFILS, ULg-CEIB, Vanessa BINAME, DG Post | AFMPS, Françoise SCHLEMMER, Quasys Consult, Henri DECLOUX, MEDI-LINE

Matériaux médicaux implantables : le point aujourd’hui

Avec le soutien de :

Federal agency for medicines and health products

Medical devices – New Belgian Landscape Plan of our Public Health Minister

Vanessa Binamé

Subject famhp/entity/Division-Unit-Cell

Date 2

Legal context

§  The law establishing the creation and the functioning of the Federal Agency for Medicines and Health Products of July 20 2006 (B.O.J. 08.09.2006)

§  The Law on the medicinal products of 25.03.1964 (B.O.J.

17.04.1964) - revised dd. 01.05.2006 (B.O.J. 16.05.2006) and its implementing decrees

The FAMHP is a public interest organization with juridical personality, classified in category A referred in the law of March 16 1954 relating to the control of certain public interest organizations

FAMHP - Presentation


Date 3

“Ensuring, from development to use, the quality, safety and efficacy:

§  of medicines for human and veterinary use, including homeopathic medicines and herbal medicines, pharmacy made and officinal preparations;

§  of health products including medical devices and accessories, and raw materials (active pharmaceutical ingredients) for the preparation and production of medicines.

Ensuring, from collection to use, the quality, safety and

efficacy: § of all operations involving blood, cells and tissues,

which are also defined as health products”.* * Based on the law of 20 July 2006 (B.S. - M.B. 08/09/2006) concerning the

establishment and functioning of the FAMHP.

Mission


Date 4

‘Stakeholders’ or partners

Policy makers (Member States)

Policy makers (UE institutions

University and Research Centers

Competent authorities

(Administrations)

Healthcare professionals

Industry

Patients


Date 5

Organisation chart


Date 6

Medical devices

New Belgian Landscape

Plan of our Public Health Minister


Date 7

Why a plan?

Medical Devices •  Essential for the health sector •  Source of innovation •  Improve the quality of life

Ø  Better traceability, evaluation and control will increase the quality and safety of medical devices

Ø  A clear legal framework with direct sanctions will eliminate the crooks, smugglers and the ignorants

Ø  ⇒ A scandal like the PIP should never happend again!


Date 8

Structure of the plan

8 strategic axes


Date 9

Traceability

Objectives •  Full traceability from the manufacturer to the

patient for each medical device implanted

•  Able to know at every moment where a specific device is

•  Opportunity for the patient to consult which medical device was implanted to him


Date 10

Traceability

"   Better knowledge of what is on the Belgian market "   Better knowledge of what is in the patient "   Better information of the patient "   Better capacity of control

⇒ Short time and specific reaction in case of incident


Date 11

Traceability - Representation

Manufacturer Intermediate Distributors

Distributors

Pharmacy (Hospital / Retail)

Patient

Distribution / Implantation

Information exchange

Central Registration

Health Professionals

Data on request


Date 12

Traceability

•  Participation of all the actors concerned

•  Simple, friendly, should not be an additional burden for §  Industry §  Health professionals §  Authorities

⇒ Focus on the essential


Date 13

Traceability

Identification of Ø  Implantable medical devices (authentic source / famhp)

Ø  Distributors of implantable medical devices (authentic source / famhp)

Ø  Pharmacies (authentic source / FPS Public Health, INAMI, famhp)

Ø  Health professionals (authentic source / FPS Public Health)

Ø  Patients (entirely coded)


Date 14

Traceability

Registration Ø  Data on implantable of medical devices

Ø  Movements from the final distributor to the patient


Date 15

Traceability

New rules

•  Implantable on « pres/post »cription (document from a doctor for a specific patient)

•  Distribution via pharmacy ⇒ strenghtening of the role of the pharmacist

•  Notification of the use of an implant

•  use of implantable medical devices only if already registred in the traceability system


Date 16

Traceability

•  Integration in eHealth plateform

•  Data exchange from system to system

•  Generation of a patient’s information carte

•  Use international standardisation and national conversion tables when really needed

•  Exchange data with Eudamed II / III

•  Respectful for the private life of implanted patients


Date 17

How can regulators, industry and health care providers work together on this

•  Should be a win/win situation for everyone

•  Communication – Concertation - Step by step approach

•  Development of interfaces system to system

•  Let all the doors open and pay attention to the SMEs

•  Take into account the advanced states of technological development (eg UDI, Combined Products, Combination Packages,…)


Date 18

Control

Distributors •  Each belgian distributor will be inspected once every 5

years •  Start with the distributors of implants

Thematic controls •  Control focused on specific points (materiovigilance

conformity, notification obligation, europeese issue, border line products,…)

•  Re-Testing on medical devices (risk based analysis, cost, availabilities of laboratory)


Date 19

Control

Publicity and information to patient (or health professional)

•  Clear rules for medical devices advertisement and

information

•  Methodology of control for publicity and information


Date 20

Control

•  Fraud

"   false CE mark, "   medical devices on our market without CE mark

•  Clinical trials

"   GCP, "   notification to the afmps, "   Deviation from the protocol


Date 21

Control

•  Efficiency of control

"  Check list "   Standardisation and simplification of the report "  Administrative support "  Progressive and continue training of inspectors

in the medical devices area "  Autocontrol


Date 22

Control

•  Information of all the actors

•  Rapid and direct sanctions


Date 23

Control

Redevance

"   Every distributors has to participate to the regulation of the medical device landscape

"   Benefit for everyone: the patient and the sector


Date 24

Evaluation

•  Enlargement of the expertise inside famhp

•  Better view on clinical trial

•  Link with materiovigilance and FU of clinical trials

•  Collaboration with ethic committees

•  Check of the capacity for clinical evaluation for the notified bodies and peer review for high risk MD


Date 25

In the recast chapter VIII: •  Establishment of an expert committee

(Medical Device Coordination Group - MDCG)

•  Members appointed by the Member States

Benefice risk evaluation >< safety and performance?

Evaluation - European Expert Group


Date 26

Tasks MDCG 1.   Contribution to the assessment of notified bodies 2.   Contribution to the assessment of higher risk

medical devices 3.   Development of guidance 4.   Coordination in the fields of clinical investigations,

vigilance and market surveillance 5.   To provide advices to the Commission



Date 27

In discussion (recast) 1.   Extension of the responsibility of the EMA to

medical devices and creation of a Medical Device Expert Group at this agency;

2.   Creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency;

3.   Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution;

4.   Creation of a Medical Device Expert Group managed by Member States



Date 28

Strenghtening of assessments and controls of notified bodies

•  Stricter and detailed requirements to be met by Notified Bodies – Recast Annex VI

•  In regular intervals, monitoring of Notified Bodies including ‘joint assessments’ (experts from other MS and EC)

Evaluation – Notified bodies


Date 29

Materiovigilance

•  Contact points network for hospitals

•  Contact points network for companies

Materiovigilance network

Hospital Distributors

FAMHP

CP

Materiovigilance

CP


Date 30

Materiovigilance

Objectives of the contact points •  Better orientation of all messages related to

materiovigilance

•  More specificity

•  Direct to the right person

•  Privileged interlocutor with the authority


Date 31

Materiovigilance

•  Standard (european) procedures for evaluation and notification of risks / incidents

•  Sensibilisation of the actors

•  Optimalisation of the assessment of incident


Date 32

Other axes

Transparency •  Involvement of patient representatives •  Discussion about the publicity rules

Monitoring •  Steering committee •  Check the implementation for each action included

in the plan •  FU of the working groups


Date 33

Other axes

Legislation •  New law and royal decree

Admnistrative simplification •  One stop = famhp

⇒ Transfert of competencies from Economic affairs and ISP to famhp


Date 34

Thank you!!!


Date 35

Federal agency for medicines and health products - famhp

Place Victor Horta 40/40 1060 Bruxelles

tel. 0032 2 524 80 00 fax 0032 2 524 80 01

e-mail [email protected]

www.afmps.be

Contact

Your medicines and health products, our concern

Matériaux médicaux implantables : le point aujourd’hui par Vanessa Binamé | Liege Creative,...

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Transcript of Matériaux médicaux implantables : le point aujourd’hui par Vanessa Binamé | Liege Creative,...