Netherland medical devices compliance update


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Presentation of 15 January 2014 at Eucomed Compliance Committee Meeting in Brussels

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Netherland medical devices compliance update

  1. 1. COMPLIANCE NETWORK DUTCH UPDATE MedTech Europe 15 January 2014 Erik Vollebregt
  2. 2. What’s going on in NL? • • • • GMH developments – mutuality Dutch lobby for HCP interaction provisions in MDR and IVDR proposal Enforcement developments Transparency / Sunshine
  3. 3. GMH – Mututality • Problem of “HCP shouldn’t ask what industry is not allowed to offer” • As of 1 January 2014 hospitals and doctors associations have agreed to comply with GMH code • NVZ & NFU • KNMG and Orde van Medisch Specialisten • Not all HCPs bound yet though • Nurses (V&VN) • Institution for long-term care (Actiz) • Minister want to involve healthcare insurance funds as well because of their role in the purchase of medical devices
  4. 4. Dutch lobby MDR and IVDR • Dutch Minister of Health unhappy with enforcement tools re HCP interaction • IGZ (competent authority) should be able to enforce in addition to self regulation • Dillema: national or EU solution? • Dutch have put it on the agenda for MDR and IVDR revision and will keep pushing the point • Late in the legislative process and so far difficult to see if there is any traction – may however pop up post elections if MDR and IVDR do not complete pre-elections
  5. 5. HCP interaction enforcement by CA IGZ • While waiting for Brussels, NL wants to do something in terms of HCP interaction enforcement • Change in Act on Medical Devices under construction • Analogous to provisions on hospitality in Medicinal Products Act, supplemented by self regulatory standards • Amendment to be tabled in 2014; entry into force expected by 1-12016 • Unclear if and how the enforcement competence will apply to different product groups and risk classes – Minister says amendment will be analogous to “medicinal products logic”
  6. 6. Generally: CA enforcement up and experimental • Visible increase in CA enforcement in NL • “new” sectors • As of 1-1-2014 IGZ actively enforces in medical software field on medical device law • Joint Immediate Action Plan gone wild • IGZ has adopted policy to enforce against authorised representatives as if they are manufacturer for manufacturer infringements • IGZ has adopted policy to redo Ethical Committee approvals for clinical investigations based on manufacturer’s notification duty
  7. 7. Transparency / Sunshine • Minister wants public transparency of HCP – industry relations • To be implemented in self-regulation like with medicinal products • Entry into force 2015 • GMH body to present proposal shortly • Transparency to be limited only to “interactions relevant to the patient” • Example given by Minister “gloves: no, pacemakers and hip replacements: yes. Implants should always be covered. Scope of products flexible.” • Infrastructure: Transparantieregister Zorg
  8. 8. THANKS FOR YOUR ATTENTION Erik Vollebregt Axon Lawyers Piet Heinkade 183 1019 HC Amsterdam T +31 88 650 6500 F +31 88 650 6555 M +31 6 47 180 683 E @meddevlegal B READ MY BLOG:
  9. 9. Legal stuff • The information in this presentation is provided for information purposes only. • The information is not exhaustive. While every endeavor is made to ensure that the information is correct at the time of publication, the legal position may change as a result of matters including new legislative developments, new case law, local implementation variations or other developments. • The information does not take into account the specifics of any person's position and may be wholly inappropriate for your particular circumstances. • The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.