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ARCS Summit Round Up - Stream 'E' - Essential updates (including EU MDR) for regulatory medical device professionals

ARCS Summit Round Up - Stream 'E'

Essential updates (including EU MDR) for regulatory medical device professionals

​E1. EU MDR: Update from a regulator’s perspective

Medical Devices updates. "Safety must be visible to restore trust". Session E1 at today’s ARCS Summit discussed “EU MDR: Update from a regulator’s perspective”.


Medical device regulation in Europe involves a common framework.

The objectives of legislative reform include:
  • Consistently high level of health and safety protection for EU citizens

  • Free and fair trade of medical devices throughout the EU

  • Adaption to significant technological and scientific progress in the sector over the last 2 decades


must be visible for all stakeholders ie everything needs to be in the public arena for re-view.

EUDAMED = European Database on Medical Devices.

Continuous improvement

is moving into Regulatory Affairs.

The basis

of all the initiatives is to restore trust.

The changes are being driven

by consumer demands for more transparency and confidence in product safety.

TGA staff

have focused on assessments of devices for COVID efforts therefore difficult to progress reform activities.

Tracey Duffy
Gert Bos, PhD, FRAPS
George Faithfull
Arthur Brandwood
Gary Burgess

E2. EU MDR: Impact on supply of devices in Australia (and how to use approvals from other over-seas regulators)

Advice for manufacturers going to market with a medical device was the topic of discussion during Tuesday afternoon’s ARCS E2 session.


Decisions regarding the best strategy

to enter the Australian market include considering registering in an overseas market first (depending on the product and the pathway); and preparing global regulatory submissions from one common technical data set.

The designation of Notified Bodies

is taking longer than expected; and because of COVID the date of activation is now May 2021.

There’s currently a European gridlock:

Notified Bodies have to recertify every device; the assessment standards are more rigorous; there are far fewer Notified Bodies and this means long delays.

For Australia the TGA

has expanded on the Reliance program, and there’s a broader pathway apart from CE.

Reliance is the recognition of international evidence

for the purpose of making a local regulatory decision; and includes the acceptance of status in overseas market; acceptance of evidence and acceptance of decisions.

George Faithfull
Arthur Brandwood
Terrance Thiel

E3. EU MDR: the supply of devices into Europe

MDR insights from ResMed and Cochlear were presented during Session E3 on Day 3 of the ARCS Summit.


An MDR strategy for maintaining supply into Europe involves:
  • Engaging with the Notified Body and understanding the process

  • Conducting a gap analysis to understand what is required to become MDR compliant (using Subject Matter Experts and project teams)

  • Conducting a product portfolio review

  • Extending existing MDD certificates

  • Identification of the various workstreams eg clinical documentation, post market documentation

  • Product development & technical files, labelling, understanding EUDAMED

  • Working with suppliers to ensure compliance

  • Conducting internal and external audits

Challenges include:
  • Maintaining momentum (considering other business priorities)

  • Notified Body readiness; separate audits for active and non active devices

  • Updating documentation for older products

  • Harmonising European operations into one QMS

  • Managing the Technical File Review complexity

  • Cybersecurity

  • Biocompatibility

  • Consistency

  • Cost (has increased >150% in most areas)

Johanna Wright
Nils Bown
Gert Bos, PhD, FRAPS
Mathew Blanch

E4. The use of registries in value-based healthcare

Clinical registries provide RWE and can be used to identify the best patient outcomes. Session E4 of Thursday’s ARCS Summit is discussing: “The use of registries in value-based healthcare”.


“Value based healthcare”

is an approach where value is assessed in terms of patient/clinical outcomes achieved per the cost of delivering these outcomes.

Data is collected

using a variety of methodologies including Patient-Reported measures, which measure patients’ own perceptions of their experience while receiving care.

The International Consortium of Health Outcomes

(ICHOM) highlights that outcomes are the results of treatment that patients care about most, not ‘outputs’.

Standard ICHOM

sets are developed by international working groups of clinicians, registries leaders, outcomes researchers and patient advocates; and include a combination of administrative, clinical and patient-reported data.

Initiatives across Australia

include a range of State programs; and the National Health Reform Agreement Addendum 2020-2025 provision for innovative funding models.

Stephen Graves
Megan Keaney
Elizabeth Koff
Alison Verhoeven
George Faithfull

E5. An update from the Medical Devices Authorisation and Regulatory Compliance Branches, TGA

An update of the TGA’s response to COVID was presented at Session E5 of Friday’s ARCS Summit.


  • Sharing of information with international regulators, through established channels

  • Increase in applications and enquiries received for PPE, COVID test kits, disinfectants, ventilators

  • Expedited application process for COVID related applications

  • Various exemption pathways were introduced

  • Established safety considerations for healthcare providers seeking to decontaminate N95/P2 respirators for reuse

  • Changes to process for including Class 1 medical devices and class 1 IVDs in ARTG 

The TGA also enhanced
their COVID communications focusing on education, especially as new sponsors entered the market with hand sanitisers, disinfectants and face masks. 

TGA also took timely enforcement action
as a deterrent factor for public safety. 

Virginia Deigan 
Meryl Clarke 
Gary Burgess