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How to survive the Perfect Storm – International Harmonization and Lessons from Brexit and the MDR
- 1. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com LIVE WEBINAR April 2019 How to survive the Perfect Storm International Harmonization and Lessons from Brexit and the MDR Arthur Brandwood and Grant Bennett
- 2. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com STORM WARNING 2017 2020 MDD MDR MDD Grace Period >? MDRNB Designations 2018 2019 ISO 13485:2003 ISO 13485:2016 CMDCAS MDSAP You are here!
- 3. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Agenda Europe • MDR implementation • Brexit Australia/APAC • Recognising International Approvals • MDSAP USA • 510k Changes • Quality • SaMD Pilot Surviving • Preparedness • Strategy • Communications 3
- 4. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com In 2011, Americans Preferred Europe “Northwestern University Survey Finds FDA Predictability a Top Concern…” Of US Companies: • 4% approached FDA first • 80% initially approached EU regulatory bodies. • 65% of devices were CE-marked before receiving FDA clearance. http://www.prnewswire.com/news‐releases/northwestern‐ survey‐finds‐fda‐predictability‐a‐top‐concern‐among‐medtech‐ firms‐europe‐preferred‐for‐product‐approval‐122514653.html
- 5. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Then Europe Changed… More Governance More Clinical Data
- 6. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com MDR Implementation
- 7. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com 13months to go… 7 The waiting lists of some notified bodies are running up to 12-14 months, whilst others are becoming more selective in the type of clients and scope of products. Gert Bos Q-Serve “Our industry is prepared to submit product files to comply with the new Medical Device Regulation (MDR). However, we cannot do so. The new regulatory system is not ready to function”
- 8. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com There is also the question of Brexit. Without agreement that the UK stays connected to the EU in a manner like Switzerland, it will no longer have notified bodies after March June 2019, Erik Vollebregt Axon Lawyers Devices Sold in Europe Devices Imported into Europe 50% 70% Devices CE Marked by UK Notified Bodies13months to go… EU27 UK Source: BSi
- 9. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com CE as a Global Passport 9 Fast Track Have Your Certificates Ready
- 10. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com CE (or GHTF) as a Global Passport Singapore • Expedited pathways for GHTF‐founder approved devies Taiwan • Expedited Class II review if both CE and FDA approved Saudi Arabia • Verification of GHTF member approval plus application audit Malaysia • Review of CE approval plus technical audit Australia • Accepts CE and now other jurisdictions 10
- 11. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Paths to Market - Australia Australian Market ARTG Registration Application TGA Conformity Assessment European CE Mark OR
- 12. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com CE TGA More than 90% of Devices Subject to Australian TGA review are registered based on CE certification
- 13. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com IIb III, AIMD Is/m IIa ARTG + QMS Certificate MDSAP OR Japan QMS Certificate MDSAP Product & QMS Assessment Application Audit Product Assessment PMA Ninsho 510(k) or De novo License IV License II License III Shonin OR
- 14. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com US is improving
- 15. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com FDA changes • No‐predicate submissions for lower risk devices • De Novo program 510k program • Based around manufacturer competence SaMD trial • Emerging Global consensus on device Quality Systems and Audit QSR to ISO 13485 (and MDSAP)
- 16. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Technical Convergence Increasing emphasis on clinical evidence by FDA – especially in De Novo submissions European use of predicate comparisons in Clinical Evaluation Convergence on Quality Systems Common Consensus (ISO) standards
- 17. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com FDA’s Proposed Future SaMD PreCert program 17 “Potentially precertified companies could market their lower-risk devices without FDA premarket review or only a streamlined premarket review based on the company's precertification level and IMDRF risk categorization.” This is starting to look like Conformity Assessment!
- 18. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Surviving the Storm - Regulatory Core Technical File • Consensus Standards based • Adapt to each jurisdiction • Clinical Evidence is Paramount Proactive Postmarket • Gather data • Monitor trends • Act! Regulatory Intelligence • Standards and State of the Art • Changing requirements • Act! 18
- 19. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Clinical Evidence is Paramount Review of Risk Assessment Postmarket Clinical Follow Up Review of Clinical Data Clinical Literature Predicate Comparisons Clinical Studies Postmarket Data 19
- 20. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Surviving the Storm - Commercial Market Strategy • What are the commercial imperatives Regulatory Strategy • The Art of the Possible Communicate • Internally • Customers • Investors 20
- 21. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Time for Q&A... Think of something later? Ask us by email... help@brandwoodbiomedical.com
- 22. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com Documentation Deconstructed: Understanding the Technical file Good documentation is about doing it once. We explore how to use the Design Controls to build a core Technical File, and to use it to create DHF, DMR, Design Dossier and regulatory filings such as 510(k) and PMA. 22 May (US) 23 May (Australia) 22
- 23. © 2019 Brandwood Biomedical www.brandwoodbiomedical.com https://www.brandwoodbiomedical.com/ @arthurbrandwood https://www.linkedin.com/in/arthurbrandwood/ https://www.linkedin.com/company/559736 You Tube Channel Brandwood Biomedical or https://brandwoodbiomedical.com/training-videos/