This document discusses key current and future regulatory challenges in the medical device and IVD sector. Regulations are constantly evolving as the types of products in these sectors expand unpredictably. In the EU, directives have been amended over time and new regulations will be introduced. In the US, the 21st Century Cures Act aims to streamline FDA regulations but may allow unsafe devices on the market. The new EU regulations will increase requirements for clinical evaluation, post-market surveillance, and Notified Body involvement for most IVDs. Distinguishing medical software and ensuring data protection and quality submissions will also be challenges going forward.

1. Diane Hatziioanou
Key current and future regulatory challenges in
the Medical Device and/or IVD sector

2. Presentation structure
 Part 1: Regulations evolve
 Part 2: FDA regulations
 Part 3: European regulations
 Part 4: Summary

3. Part 1:
Regulations evolve

4. Medical devices and in vitro diagnostics evolve
 The type of products categorized as medical devices and IVDs is
constantly expanding
 In the EU a number of directives and regulations may apply to
medical devices
 Council Directive 90/385/EEC on Active Implantable Medical Devices
(AIMDD) (1990)
 Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
 Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD)
(1998)
 2002/98/EC covers blood products
 Directive 2007/47/EC amended AIMDD and MDD and all directives have
smaller amendments
 Challenging to create a regulatory framework which can be:
 strong and specific to ensure development of safe and
effective devices
 broad enough to remain applicable over a longer period of time

5. Regulatory requirements follow the basic
principles of biological evolution
 Geography:
 Regulations for conducting medical device clinical trials vary around the
world
 Complications that arise between trials conducted under different
protocols make bringing a device to market difficult in a stricter country
 Despite efforts to harmonize requirements country-specificity may be
maintained
 Unpredictability:
 Issues are evolving and changing. Even where there appear to be clear
regulatory requirements, it is not yet known or not always reasonably
foreseeable how they will be implemented
 In the EMERGO group Global Medical Device Industry Outlook for
2016 ~60% of medical device industry participants cite changing
regulatory environments as their biggest challenge

6. 1/3 of professionals consider that the process of
obtaining regulatory approval became more
difficult in 2016 in US and EU
EMERGO group 2016 Outlook for the medical device industry

7. Medical Device regulators need to be aware
of and implement regulatory changes
*EMERGO group 2016 Outlook for the medical device industry

8. *EMERGO group 2016 Outlook for the medical device industry

9. Part 2:
FDA regulations

10. FDA regulations
 New legislation significantly impacting FDA oversight of US
medical device and drug markets has passed Congress and is
awaiting President Obama’s signature
 The 21st Century Cures Act would
 establish a priority review program for breakthrough devices
 loosen some device clinical trial requirements
 clarify how and whether to regulate medical software

11. Benefits from less strict and broad
regulation need to be balanced with risks
 Streamlining FDA regulations may end up allowing
devices into the US market without proper vetting,
causing public health issues
 Accidents and crises may lead to further re-writing of
regulations
 Eg The 2010 Poly Implants Protheses (PIP) silicon breast
implant story

12. The impact of risks
 Medical device recalls hit a high in the 3rd
quarter of 2016*
 The number of device recalls was the highest
observed since 2000
 The number of recalled units was the highest since
the third quarter of 2012
 Recall reasons included:
 complaints of dangerous quality issues
 reports of serious adverse events
 deaths
*Q3 report from the Stericycle ExpertSolutions Recall Index of the FDA's
medical device recall database

14. Part 3:
European regulations

15. European regulations
 Shortly after the PIP scandal the Commission published
draft Regulations in 2012
 15 June 2016: Council and Parliament reached
agreement on the final text
 Early 2017 (expected): Adoption and publication of new
regulation
 One for medical devices (3 year transition)
 One for in vitro diagnostic devices (5 year transition)
 Dilemmas to R&D on whether to invest in bringing old
products up to the new regulatory framework or invest
in new products

16. Some major changes
 Manufacturers and importers will have to register themselves
and the devices in a central database (Eudamed)
 Manufacturers of medical devices will have to fit their products
with a unique device identification
 Reinforced rules governing clinical evaluation, introduction of
a ‘sponsor’, new requirement for manufacturers to have a
‘qualified person’ responsible for regulatory compliance
 A post-market surveillance system detailing manufacturers’
responsibilities for the follow-up of the quality, performance and
safety of devices placed on the market
 These include annual periodic safety update reports (PSURs) – a step
which brings medical devices into line with pharmaceutical reporting
requirements

17. IVDs
 The majority of IVDs which are currently self-certified will in
future require the services of a Notified Body to ensure their
safety and performance.
 The proposed changes also include extending and clarifying the
scope of the IVD Directive to include:
 high-risk devices manufactured and used within a single
health institution
 genetic tests
 companion diagnostics (providing information to predict
treatment response or reactions)
 medical software

18.  Under the terms of the Trilogue, amendments made to
the text by the European Parliament that were
subsequently deleted by Member States can be re-
introduced.
 Parliament might want to add rules for IVDs:
 mandatory genetic counselling to accompany every
genetic test
 tests can only be carried out by medical professionals
Uncertain changes

19. Software complications
 Distinguishing between lifestyle and well-being apps
 More medical devices are being implanted,
controlled and monitored remotely by software in
the hands of doctors and patients.
 This distinction may not stand the test of time

20.  The Commission has published proposals for a
comprehensive reform of data protection rules.
 Introduction of a single pan-European to
replace 1995’s data protection rules (which
were interpreted differently by different member
states)
Data Protection

21. Part 4:
Summary

22. Summary
 A major challenge for regulatory affairs is that the
future changes have to be prepared for in the present
 The future procedures and requirements are uncertain
and prone to being amended
 New regulation also affects existing marketed products
 Historical accidents and recalls call for caution in
following only the necessary requirements

23. Thank you for listening
Dr Diane Hatziioanou
DianeHioanou@gmail.com
UK Mobile: (+44)7779516625
Greek Mobile: (+30)6909403373
www.linkedin.com/in/dhatziioanou/
https://twitter.com/DianeHIoanou

24. Compliance and quality of regulatory
submissions influences the review
period

25. Device-drug combinations
 Manufacturers have to be clear on medical device or
medicinal product classification
 In devices in which, although the device and the drug
is one unit and the manufacturers argue the drug
cannot act on the human body this must be proved

26. Map of Human Migration – National Geographic