Brief overview of the harmonization efforts in medical device regulation.

1. Shosh Friedman, RAC, FRAPS – March 2018 1
Medical Device Regulation:
Where are we heading to?
Shoshana (Shosh) Friedman, RAC, FRAPS
President and CEO of ProMedoss, Inc.
MDI Conference, March 2018

2. 2Shosh Friedman, RAC, FRAPS – March 2018
 The Global Harmonization Task Force on
Medical Devices (GHTF) was founded in 1992
in “an effort to respond to the growing need
for international harmonization in the
regulation of medical devices“
 The founding members consisted of
regulatory authorities and industry members
from the EU, USA, Japan, Australia and
Canada
Harmonization Efforts in Medical Device
Regulation

3. 3Shosh Friedman, RAC, FRAPS – March 2018
 The GHTF was disbanded in 2012 and its
mission taken over by the International
Medical Device Regulators Forum (IMDRF), a
successor organization composed of officials
from regulatory agencies around the world,
without industry representatives
Harmonization Efforts in Medical Device
Regulation

4. 4Shosh Friedman, RAC, FRAPS – March 2018
 Australia
 Brazil
 Canada
 China
 Europe
Harmonization Efforts in Medical Device
Regulation
 Japan
 Russia
 Singapore
 South Korea
 USA
 Current members of IMDRF are:
 Official Observers: World Health Organization (WHO) and
APEC LSIF Regulatory Harmonization Steering Committee
 Affiliate Organizations: Asian Harmonization Working Party
(AHWP) and Pan American Health Organization (PAHO)

5. 5Shosh Friedman, RAC, FRAPS – March 2018
Harmonization in Medical Device
Regulation – Are we getting closer?
 Center for Devices and Radiological Health (CDRH) in FDA is
responsible for assuring that patients and providers have
timely and continued access to safe, effective, and high-
quality medical devices and safe radiation-emitting products
 Therapeutic Goods Administration (TGA) reviews medical
devices to assess their safety and performance before being
included in the Australian Register of Therapeutic Goods
(ARTG)
 Health Canada reviews medical devices to assess their safety,
effectiveness and quality before being authorized for sale in
Canada

6. 6Shosh Friedman, RAC, FRAPS – March 2018
EU Classification
CLASS RISK
I Low
IIa Medium
IIb Medium
III High
Harmonization in Medical Device
Regulation – Are we getting closer?
CLASS RISK
I Low
II Medium
III High
FDA Classification

7. 7Shosh Friedman, RAC, FRAPS – March 2018
Substantial Equivalence
 In the US, the majority of new devices are
placed on the market through the 510(k)
process, which was created in May 1976
 The new EU medical device regulation
allows the manufacturer of a device, proven
to be the equivalent of an existing device, to
skip conducting a clinical trial
Are we getting closer to harmonization?
Not exactly….

8. 8Shosh Friedman, RAC, FRAPS – March 2018
Substantial Equivalence
 The new regulation says the manufacturer of a
device proven to be the equivalent of an existing
device may not conduct a clinical trial provided
that the following conditions are fulfilled:
 The two manufacturers have a contract in place that
explicitly allows the manufacturer of the new device
full access to the technical documentation of the
marketed device;
 The clinical evaluation with the older device has
been performed in compliance with the MDR and its
manufacturer provides clear evidence thereof to the
notified body.

9. 9Shosh Friedman, RAC, FRAPS – March 2018
Substantial Equivalence
 The new regulation says the manufacturer of a
device proven to be the equivalent of an existing
device may not conduct a clinical trial provided
that the following conditions are fulfilled:
 The two manufacturers have a contract in place that
explicitly allows the manufacturer of the new device
full access to the technical documentation of the
marketed device;
 The clinical evaluation with the older device has
been performed in compliance with the MDR and its
manufacturer provides clear evidence thereof to the
notified body.

10. 10Shosh Friedman, RAC, FRAPS – March 2018
Substantial Equivalence
 The new regulation says the manufacturer of a
device proven to be the equivalent of an existing
device may not conduct a clinical trial provided
that the following conditions are fulfilled:
 The two manufacturers have a contract in place that
explicitly allows the manufacturer of the new device
full access to the technical documentation of the
marketed device;
 The clinical evaluation with the older device has
been performed in compliance with the MDR and its
manufacturer provides clear evidence thereof to the
notified body.

11. 11Shosh Friedman, RAC, FRAPS – March 2018
Getting Closer to Harmonization –
Global QMS Standard
 Unlike the Medical Device Regulation (MDR),
which preserves the essential differences in
the regulatory framework (classification,
conformity routes vs. submission, etc.), the
new revision of ISO 13485 does indeed move
toward harmonization
 ISO 13485:2016 has been incorporated into
the Medical Device Single Audit Program
(MDSAP)

12. 12Shosh Friedman, RAC, FRAPS – March 2018
Getting Closer to Harmonization –
Global QMS Standard
ISO 13485:2016 is now part of or harmonized with:
 The Conformity Assessment Procedures of the
Australian Therapeutic Goods (Medical Devices)
Regulations (TG(MD)R Sch3)
 The Brazilian Good Manufacturing Practices (RDC
ANVISA 16/2013)
 The Japanese QMS Ordinance (MHLW MO 169)
 The Canadian Medical Devices Regulations (ref #
16-108859-627)
 The FDA Quality System Regulation (21 CFR Part
820)

13. 13Shosh Friedman, RAC, FRAPS – March 2018
Harmonizing QMS
ISO 13485:2016 and QSR (21 CFR 820)
 ISO 13485:2016, Clause 4.2, Documentation
Requirements:
 Two major changes related to protecting
confidential health information and
requirements to address deterioration
and loss of documents
 In line with expectations as defined in FDA
21 CFR 820.5, Quality System, 820.40
Document Controls, and 820.180 Records

14. 14Shosh Friedman, RAC, FRAPS – March 2018
 ISO 13485:2016, Clause 6.2, Human
Resources:
 Requires processes for establishing
competence, providing needed training,
and ensuring awareness of personnel be
defined and documented
 In line with FDA requirements for personnel
and training in 820.25
Harmonizing QMS
ISO 13485:2016 and QSR (21 CFR 820)

15. 15Shosh Friedman, RAC, FRAPS – March 2018
Harmonizing QMS
ISO 13485:2016 and QSR (21 CFR 820)
 ISO 13485:2016, Clause 7.3.8, Design and
Development Transfer:
 Added explicit criteria to describe
requirements of transferring a product
from D&D to production
 Strengthens the similarities to the long
established 21 CFR 820.30(h), Design
Transfer

16. 16Shosh Friedman, RAC, FRAPS – March 2018
 ISO 13485:2016, Clause 7.3.10, Design and
Development Files:
 Added explicit criteria to define
requirements for maintaining design and
development files
 Strengthens the correlation to the long
established FDA 21 CFR 820.30(j), Design
History File
Harmonizing QMS
ISO 13485:2016 and QSR (21 CFR 820)

17. 17Shosh Friedman, RAC, FRAPS – March 2018
 ISO 13485:2016, Clause 7.5.8, Identification:
 Requires documented procedures as it
relates to production identification and
status throughout all stages of product
realization
 References use of UDI
 Aligns with FDA 21 CFR Part 820.60,
Identification, and with subpart B of Part
801 pertaining to UDI
Harmonizing QMS
ISO 13485:2016 and QSR (21 CFR 820)

18. 18Shosh Friedman, RAC, FRAPS – March 2018
 ISO 13485:2016, Clause 8.2.2, Complaint
Handling:
 New and specific requirements
pertaining to complaint handling
 Strengthens the connection between the
standard and 21 CFR Part 820.198,
Complaint Files
Examples of Harmonizing ISO
13485:2016 and FDA QSR (21 CFR 820)

19. 19Shosh Friedman, RAC, FRAPS – March 2018
So where are we?
Still somewhere on our way
(and time will tell how tall this
mountain is…)

20. 20Shosh Friedman, RAC, FRAPS – March 2018
Questions?

21. 21Shosh Friedman, RAC, FRAPS – March 2018
Thank You!