Medical Technologies in Belgium: overview & challenges. Karel Verlinde - bemedtech

Transcription

1 Medical Technologies in Belgium: overview & challenges 20/02/2018

2 On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May These replace the existing Directives Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 2

3 Content of the new regulations: Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism 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; The introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance; 3

4 Content of the new regulations: Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification; The introduction of an implant card containing information about implanted medical devices for a patient; The reinforcement of the rules on clinical evidence, the strengthening of post-market surveillance requirements for manufacturers; Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance. 4

5 Unique Device Identifier (UDI) 2. UDI Carrier = AIDC (x) (y)gh12345(z) linear bar code of andere static data device ID 1. UDI Code 3. production ID dynamic data expiration date lot/serial no. of Rfid UDI database (network) 5

6 UDI: deadlines Class III: 2021 Class IIa & IIb: 2023 Class I:

7 Overview Medical Devices 7

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9 Definition Medical Device Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. 9

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12 Class I Medical Device Minimal potential risk for the patient/user Non-invasif No direct contact with the patient or only on intact skin Simple procedure to obtain the CE-marking 12

13 Class IIa medical device Medium risk for the patient No implants with the exception of dental 13

14 Class IIb medical device High risk for the patient Invasive products Implants 14

15 Class III medical device Devices that are regarded as critical from a risk perspective in direct contact with the heart or central nervous system upgrades (breast and joint implants) 15

16 CE-marking for class IIa, IIb en III devices Technical file - Conformity with the essential requirements - Clinical evaluation Intervention of a third party "Notified Body" - Specialized in medical devices - Indicated and controlled by the Member States - List published in the Official Journal of the EU Notified Body - Check the technical and clinical documentation - Check the production process on a regular basis - Inspections at unexpected times 16

17 Definition In-vitro diagnostic Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software 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 17

18 In-vitro diagnostic: 3 categories Laboratory tests used in medical laboratories Point-of-care' tests used by care providers near a patient's bed Self-testing (used by consumers) 18

19 In-vitro diagnostic Healthcare budget Medical decissions 5% * Wolcott,J. & Goodman,C. (2009). The Value of Laboratory Screening and Diagnostic Tests for Prevention and Healthcare Improvement. Health Technology Report. The Lewin Group. * *DOI: /journal.pone

20 Classification of in vitro diagnostic medical devices 20

21 Competent authorities 21

22 Public Pharmacy: Medicines versus Medical devices Medicines - Monopoly for the pharmacist Medical devices - No monopoly => But there are exceptions! 22

23 1.1 het steriel medisch materiaal dat in contact komt met de patiënt ; 1.2het steriel injectie-, perfusie-, transfusie-, of drainagemateriaal alsmede de sonden en katheters, alsmede al het materiaal voor geneeskundige of obstetrische tussenkomst bestemd, dat als steriel voorgesteld wordt, inbegrepen de oplossingen voor doorbloeding en de concentraten voor hemodialyse ; 1.3 de implanteerbare hulpmiddelen (al dan niet steriel) ; 1.4 de hulpmiddelen bestemd voor de beheersing van de bevruchting en/of deze bestemd voor de voorkoming van seksueel overdraagbare ziekten ; 1.5 de hulpmiddelen die een verwantschap hebben met de geneesmiddelen en/of deze die voorheen het voorwerp waren van een registratie ; 1.7 de systemen en behandelingspakketten samengesteld uit deze hulpmiddelen. Bron: annex XIII van het KB van 18 maart

24 Selfcare Medical devices 24

25 Rule 21 - MDR Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as: class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose; class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body; class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and class IIb in all other cases. 25

26 - Healthcare professional Exceptions The first use of these tools by the professionals for a specific patient Within the limits of the exercise of their profession Not sold or offered to patients for later use - Diabetes zorgtraject - Trajet de soins diabète Glucose Monitoring Systems, strips & lancets Pharmacy Thuiszorgwinkel - Magasin de soin à domicile Patient Association 26

27 Tabel: ministerieel besluit van 18 mei

28 Tabel: ministerieel besluit van 18 mei

29 National Institute for Health and Disability Insurance (NIHDI-INAMI-RIZIV) 29

30 Sixth State Reform: impact - Labor market policy (4.7 billion euro) - Healthcare (5 billion euro) - Family suport (6.8 billion euro) - Justice - Healthcare: Care for the disabled => mobility aids 62.2 million Hospitals => 531 m Elderly care => 3.3 million Rehabilitation => 170 million Mental healthcare Prevention Organization of primary health care Healthcare professions 30

31 Expectations Driver = innovation Acquisitions/fusions Shift towards Extra-Muros Digital Health Self-testing & self-monitoring 31

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34 Toekomstpact minister De Block & bemedtech New EU-regulations Autocontrole-system Home care Reimbursement procedures of MD Digital Health amen_aan_meer_veiligheid_en_kwaliteit 34

35 Services & Technologies Home Assistance (STHA) Les entreprises qui pourront intervenir au domicile des patients pour l installation, la maintenance ou le retrait de certains dispositifs médicaux (conformes à l article 60 de la loi du 15/12/2013) Arrêté royal relatif à la notification d un point de contact matériovigilance et à l enregistrement des distributeurs et exportateurs de dispositifs médicaux (15/11/2017) Livre blanc «SERVICES & TECHNOLOGIES HOME ASSISTANCE (STHA)» 35

36 Definition Digital Health Tele Health Mobile Health Mobile authentication Tele Consult Tele Care Outside Care System Inside Care System Mobile EHR for professionals Mobile PHR for citizens Wellness Quantified Self Self Management Supervised Apps Wearables Prevention Tele Monitoring Apps Wearables Ref pilot projects 36

37 Digital Health: position paper bemedtech - DH 3 Hurdles => framework vs jungle 1. CE-Medical Device 2. Evidence 3. Financing 37

38 Digital Health: new framework in Belgium Validation pyramid => 3 Levels - Minimum requirements for every application that will have access to BE-healthcare system. => CE mark, privacy - & data security regulations. - Requirements of level 1 + interoperability - Requirements of level 2 + positive health economics evaluation => tailor-made financing model will be developed 38

39 Thank you for your attention! Any questions? 39