Medische hulpmiddelen en geneesmiddelen: Verschuivende grenzen in Brussel?

Transcription

1 Medische hulpmiddelen en geneesmiddelen: Verschuivende grenzen in Brussel? Sabina Hoekstra-van den Bosch Philips HealthTech, Global Regulations & Standards Arnhem, June 19, 2015

2 Samenvatting Verschil tussen geneesmiddel en medisch hulpmiddel (herhaling) Nieuw mechanisme voor statusbepaling van medische hulpmiddelen op Europees niveau Substance based medical devices 2 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

3 Fundamental difference between medical device and pharmaceutical 4 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

4 Simplified EU definition of a medical device Any product Intended for a medical purpose For humans Which does not act by pharmacological, immunological or metabolic means Fundamental difference with pharmaceutical products is mechanism of action 5 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

5 Statusbepaling van medische hulpmiddelen op Europees niveau 4 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

6 Statusbepaling medische hulpmiddelen in EU Huidige situatie Majority of cases: no doubt! In case of doubt: No seamless coherence between the definitions of medicinal products and medical device Decisive power lies with national judges Possibility to appeal to EU Court of Justice Demarcation procedure between pharmaceuticals and medical devices can be quite complicated! 4 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

7 Nieuw mechanisme voor statusbepaling? EU COM proposal MDR + Council changes 3 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

8 Wat betekent dit??? Sleutelwoorden/begrippen Art 2.2 of Directive 2001/83 Implementing acts MDCG 5 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

9 Medicinal Product Directive 2001/83, art 2.2 In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a medicinal product and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply. 4 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

10 Comitology Legislative process light System gradually developed from the 60-ties For implementing measures only Drafted by EU COM Voted upon by Council (Member States) by QMV European Parliament asked for the equal rights as co-legislator 2006: Veto right for European Parliament 10 1

11 Treaty of Lisbon (2010) Fundamental changes to comitology procedures, now called implementing acts Creation of a new legal instrument for delegation to EU Commission: delegated acts. Equality between EP and Council in limited control over both delegated and implementing acts (veto-right) And the winner is

12 Medical Device Coordination Group (MDCG) Commission proposal MDR art 80 Consisting of representatives of Member States (1 for MDs, 1 for IVDs, with an alternate for each) Members chosen for their competence and experience Members must be impartial Chaired and supported (logistically, technically and scientifically) by EU Commission Experts of other stakeholders (medical device industry, healthcare professionals, laboratories, patients and consumers) may be invited in subgroups as observer on case-by-case basis 12 1

13 Wat betekent dit als Medical Device Regulation van kracht is? Regulation (=Verordening) rechtstreeks van toepassing in alle lidstaten Statusbepaling dmv Implementing acts met Europese Commissie aan het roer MDCG (lidstaten) worden tevoren geraadpleegd Beroep tegen Implementing act ingewikkeld (voor gevorderde Europees juristen.) 5 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

14 substance based medical devices 13 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

15 substance based medical devices Background Increasing number of ingested or absorbed products with medical claims Not possible to demonstrate that (some of) these products have any pharmacological, immunological or metabolic action/effect Historically a lot of these products have been placed on the market as medicinal products Identical products regulated as medicinal products, medical devices or food supplements. Differences in interpretation between Member States, but also within Member States. When the Medical Device Directive was drafted (mid-eighties), legislators did not intend to cover products which are ingested or absorbed, so some adaptation might be needed in order to cover these products properly. Examples: some nasal sprays, gels for vaginal discomfort, throat lozenges, toothpastes for sensitive teeth, flushing solutions, creams to treat or prevent minor skin irritations, comfort eye drops or anti-flatulence products 15 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

16 substance based medical devices Solution: substance based medical devices defined in MDR: Adaptation of Classification rules General Safety and Performance Requirements Conformity Assessment Procedures Labelling and Instructions for use Referral to relevant provisions in 2001/83 Provoked lots of intense discussion, e.g. on Definition Risk classification 15 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

17 Definition of substance based medical devices EU COM proposal MDR + Council changes 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 16 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

18 Classification of substance based medical devices (Annex VII) 19 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

19 General Safety and Performance Requirements MDR Annex I 14 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

20 Labelling MDR Annex I, Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

21 Instructions for use MDR Annex I, Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

22 Technical documentation Annex II Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

23 Dank voor uw aandacht! 24 Arnhem, June 19, 2015 Philips HealthTech, Global Regulations & Standards

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