Medtronic Presentatie NVMETC versie 27 November Presentatie NVMETC... · §Upcoming revision of ISO...
Transcript of Medtronic Presentatie NVMETC versie 27 November Presentatie NVMETC... · §Upcoming revision of ISO...
LOOKING FOR CLARITYIN A CHANGING ENVIRONMENT
TO ENSURE COMPLIANCE
INDUSTRY PERSPECTIVE
ANNEKE HURKENSSR DIRECTOR CORPORATE CLINICAL QUALITY & COMPLIANCE
MANON GIELKENSSR REGULATORY AFFAIRS SPECIALIST
2
CONTENT
§ Introduction
§ Upcoming revision of ISO 14155§ Clinical investigation of medical devices for human subjects — Good clinical practice
§ The impact of the GDPR for Global Trials§ General Data Protection Regulation / Algemene Verordening Gegevensbescherming
§ Changes with the Medical Device Regulation§ Verordening Medische Hulpmiddelen
§ Conclusion
3
4
MEDTRONIC IN THE NETHERLANDS
§ European Operations Center (EOC) - Heerlen
§ International Distribution Center - Heerlen
§ C-Mill, Service & Repair - Heerlen
§ CardioVascular Operations - Kerkrade
§ Medtronic Trading NL B.V. Sales Office – Eindhoven
§ Bakken Research Center (BRC) - Maastricht
5
BAKKEN RESEARCH CENTER (BRC)MAASTRICHT, THE NETHERLANDS
2018
New created Center of Excellence inVALUE-BASED HEALTHCARE
6
AN INTERNATIONAL COMPANY CONDUCTING GLOBAL TRIALS
§ Most of our Medtronic clinical research studies are being conducted in multiple countries, with each their own regulation around Clinical Trials
7
COMPLEXITY WHEN GOING ACROSS THE BORDER
Imagine the complexity for Global Clinical Trials ………
8
GLOBAL TRIALS: MULTIPLE REVIEWS BY MULTIPLE REGIONSWITH EACH THEIR OWN FOCUS AREA
Authorities
Ethical reviewbodies
9
STANDARDIZATIONTO FACILITATE COMPLIANT GLOBAL RESEARCH AND GLOBAL ACCEPTANCE OF WORLDWIDE DATA
Patient Safety Scientific Soundness Data Integrity
UPCOMING REVISION OF ISO 14155
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS — GOOD CLINICAL PRACTICE
ISO 14155 Revision
NEN/NC 301085 Clinical Investigation
ISO/TC 194 WG4
Standards and Regulations 11
Standards and Regulations 12
“Standardization is the process to develop agreements among stakeholders on specific aspects of a product, service or process”
ISO:"International Organization for Standardization."
Standards and Regulations 13
• Industry• Associations• Public administrations• Academia• Societal organizations• Certification bodies
Main stakeholders
Representatives of Ethics Committees are relevant stakeholders for the NEN/NC 301085 Clinical Investigation
Standards and Regulations 14
ISO 14155ICH – GCP
US FDA regulations
Japan GCPs
IMDRF
EU MDRChina FDA
Standards and Regulations 15
HIGH LEVEL OVERVIEW OF
CHANGES COMPARED TO 2011 VERSION
Summary of main revisions
Standards and Regulations 17
Structure of ISO/DIS 14155:2018 Light blue boxes are new sections
Summary of GCP principles
Standards and Regulations 18
• Added on request of several Asian countries
• Principles were originally spread throughout the ISO standard in several clauses
• Facilitate cross-reference in national regulationto “GCP principles”
Annex G –Ethics Committee responsibilities
Standards and Regulations 19
ANNEX GThe contents of this annex are intended to provide guidance on best practices for the operation of ECs involved in the review of clinical investigations of medical devices.
ECs should also follow the requirements outlinedin national or local regulations [see 5.6.1].
5.6.1 If national or regional EC requirements are less strict than the requirements of this standard, the sponsor shall apply the requirements of this standard to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts (see Annex G).
5.8 – Informed Consent
Standards and Regulations 20
h) Information on the role of sponsor's representative (e.g. monitor, product specialist, field engineer etc.) in the clinical investigation.
c 1) description of anticipated adverse device effects;
Elements specific for medical device trials
THE IMPACT OF THE GDPR FOR GLOBAL TRIALS
22
ALGEMENE VERORDENING GEGEVENSBESCHERMINGGENERAL DATA PROTECTION REGULATION
§ Eén Europese regelgeving in plaats van 28 verschillende wetgevingen.
§ Maar 28 verschillende interpretaties van de wetgeving wat betreft het PatientInformed Consent document
§ + verschillende interpretaties per localeEthische Commissie
CHANGES WITH THE MEDICAL DEVICE REGULATION
24
EU MEDICAL DEVICE REGULATION (EU) 2017/745AANLEIDING
http://www.dailymail.co.uk/health/article-2117368/I-warned-dangers-metal-hips-15-YEARS-ago-A-whistleblower-reveals-real-scandal-danger-joints.html
http://www.theguardian.com/world/2012/jan/14/pip-implants-scandal-march-replacements
25
EU MEDICAL DEVICE REGULATION (EU) 2017/745TEXT PUBLISHED MAY 05, 2017
101 Recitals (MDD: 22 Recitals)123 Articles (MDD: 23 Articles) 17 Annexes (MDD: 12 Annexes)
Chapter I Scope and definitions Article 1 Subject matter and scope
1. This Regulation lays down rules concerning the placing on themarket, making available on the market or putting into service ofmedical devices for human use and accessories for such devices in theUnion. This Regulation also applies to clinical investigations concerningsuch medical devices and accessories conducted in the Union.2. This Regulation shall also apply, as from the date of application ofcommon specifications adopted pursuant to Article 9, to the groups ofproducts without an intended medical purpose that are listed in AnnexXVI, taking into account the state of the art, and in particular existingharmonized standards for analogous devices with a medical purpose,based on similar technology.
26
MEDICAL DEVICE REGULATION (EU) 2017/745VERANDERINGEN VOOR STUDIES
New key provisions:1. EU legal representative of sponsor is required if located outside EU2. CA notification for post-market interventional studies3. Optional single study application for studies conducted in several Member States4. At least 1 lay person for EC review
Study ConductI. Clear timelines for clinical application assessment by CAs
a. Pre-market: up to 120-day review (worst-case scenario)
b. Post-market interventional: 30-day notification timeline
II. Clear timelines and process for closure notification and final reporta. Closure notification: within 15-days (24 hours in case of termination/halt on safety grounds)
b. Final Report: within 1 year (3 months in case of early termination) accompanied by a Summary Final Report
c. Commission shall issue guideline on content and structure of the summary
III. SAE reportinga. Pre-market: (potentially) device and/or procedure related SAEs
b. Post-market: Vigilance reporting requirements (unless SAE has a causal relationship with investigational procedure in interventional studies)
IV. Eudamed database a. CA clinical application, SAE reports, Final Clinical Investigation Report (publicly available)
EU MEDICAL DEVICE REGULATION (EU) 2017/745WANNEER EEN STUDIE
Klinischeevaluatie
KlasseIII en
implan-taten Nieuwe
therapieof tech-nologie
Nieuwedesign
features
Nieuwedoel-
einden
Nieuwepopula-
tie
Nieuweclaims (S/P)
Nieuwerisico’s
* Zie Artikel 61 en bijlage XIV
Uitzonderingen
28
CONNECTIE TUSSEN PROCESSEN: KLINISCH ONDERZOEK EN KLINISCHE EVALUATIE
= Clinical Investigation
= Clinical Evaluation Process
= Risk Management process
= Output deliverables
PROCEDURE EN TIJDSLIJN
AanvraagEudamed
Besluit
NOTIFICATIE TOESTEMMING10 DAGEN (+5) 45 DAGEN (+20 voor raadpleging deskundigen)
= Valideringsdatum (als positief advies van EC) = toestemmingonderzoek IIA, IIB
10 DAGEN (+20)
Onderzoek niet ondertoepassingsgebied/ onvolledig
Sponsor dient opmerkingen in /vult documentatieaan
Acceptatie (5 dagen (+5))
Lidstaat & sponsor geen overeenstemming => aanvraag verworpen
Opmerkingen sponsor niet op tijd => aanvraag vervallen
MEDICAL DEVICE REGULATION (EU) 2017/745
Artikel 62:
Klinische onderzoeken worden onderworpen aan een wetenschappelijke en ethische toetsing.
De ethische toetsing wordt verricht door een ethische commissie overeenkomstig het nationale recht.
De lidstaten zien erop toe dat de procedures voor toetsing door ethische commissies verenigbaar zijn met de procedures in deze verordening voor de beoordeling van de aanvraag tot machtiging voor een klinisch onderzoek.
ROL VAN DE ETHISCHE COMMISSIE BIJ DE BEOORDELING
DE STAND VAN ZAKEN
CLARITY: DUIDELIJKHEID IN TAKEN ENVERANTWOORDELIJKHEDEN
CONCLUSION
34
HOW TO ACHIEVE CLARITY IN A COMPLEX AND CHANGING ENVIRONMENT TO ENSURE COMPLIANCE
Our common goal:Safe products for our patients
Standardization / Harmonization: - Importance of NEN work, including all stakeholders- Importance of the acceptance of ISO 14155 standard-Importance of International collaboration
Bring clarity in Roles and Responsibilities for all stakeholders. - No duplication of effort and no gaps- Communication /transparency on expectations
35