Medical Device Reporting For Manufacturers

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NEW MEDICAL DEVICE REGULATION Implications for
Medical Device Manufacturers
TAGS Pepgra Medical Device Reporting Medical
Device
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BACKGROUND
The implementation of the new Medical Device
Regulations (MDR) on 25th May, 2017 has
presented medical device manufacturers with
several drastic changes in the decades old
regulatory framework of the European Union
(EU). The new MDR has effectively replaced the
previous medical device directive (93/42/EEC) of
the EU and also the directives relating to active
implantable medical devices (90/385/EEC). The
new MDR offered medical device manufacturers with
already approved devices in the market with a
compliance time of three years till 26th May,
2020. For certain medical device manufacturers,
the new MDR offered extra time following the
date of application which enables them to provide
new products to the medical device market for a
maximum extended time of four years. However, in
this case, extra requirements would be
applicable for this additional period of
transition.
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Objective of the New MDR
The key objectives of new MDR to make a two
dimensional impact in enhancing the safety of
medical devices (Laege Middle Styrelsen, 2019)
are Reinforcing the rules associated with
placing new medical devices within the market.
Increasing surveillance post the devices
availability in the market.
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Implications of the New MDR for Medical Device
Manufacturers
The new MDR warrants the need for conclusive and
hard evidence that is based on data for existing
as well as new medical devices (Lehmann, 2019).
Implications are Setup systems for managing
quality and risk. Consistently gather clinical
evidence for their devices following its market
release, to validate the effectiveness as well as
safety of the device. Provide data reports on a
new Centralized Electronic System which will be
easily available to the public. Be responsible
for determining devices that requires
reclassification and those that require
additional review by a notified body. Setup
systems that encompass their financial
obligations in the event of unwarranted harm that
arises from a defective device. With the new MDR
in force, the objective is to reinforce the rules
associated with clinical investigation of medical
devices, with a view to improve the availability
of valid clinical information.
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Challenges for Medical Device Manufacturers
Medical device manufacturers are expected to
affect substantial alterations in terms of
quality assurance, product development and data
reporting. Enforcement of the new MDR would mean
higher cost implications and extended time
required for new product development. The process
of clinical monitoring and gathering evidence for
recertification of existing products could also
prove to be an expensive proposition.
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FOUR KEY CHALLENGES POSSED BY NEW MDR POSES FOR
MEDICAL DEVICE MANUFACTURERS
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Major modifications will be effected to the
classification of medical devices.
In this case, requirements would be largely
evaluated based on risk it presents to patients.
For instance, specific devices that will be used
on spinal cord will move up the order from class
II to class III.
RECLASSIFICATION
As a process, reclassification of devices will
have to undergo expensive process of
certification for new products and also
recertifying products that are already in the
market.
The focus of the new MDR would shift from
approval of product to its whole lifecycle,
warranting higher clinical assessment prior to
approval.
This would no doubt substantially slow down the
production of medical devices.
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High Clinical Testing Needs
Another key challenge that manufacturers are
confronted with pertains to the increase in
requirements for clinical testing. Owing to
reclassification, manufacturers in the past who
were not required to execute clinical testing,
now need to be able to do so. New regulations
also necessitate a reevaluation of clinical data
pertaining to devices that already exist in the
market. In the event that the data does not
match the new requirements, medical devices need
to be put through additional testing for
recertification. This further augments the cost
of sustaining legacy devices.
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High Demand for Notified Bodies
Notified bodies (NBs) acted as consultants in
facilitating medical device manufacturers to
adhere to the requirements for CE
markings. With the enactment of the new MDR, NBs
will assume the role of enforcers who will assess
all medical devices (other than IVDs), those
that fall above class I. The shortage of NBs to
evaluate devices, specifically in devices classes
that are of higher risk, will lead to a delay in
approval for products and slow the entry of a
device into the market. Timelines are bound to
be increased considering that NBs have a huge
volume of data to review. This in turn, would
tend to increase costs on the whole.
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Significance on Post-Market Surveillance
Under the new MDR, much stress is being laid upon
post-market surveillance. This would comprise
of preemptive monitoring of the performance of
medical devices for yearly safety updates for
devices falling in the high risk class,
recertification and prompt reporting of incidents
concerning device safety. This kind of intense
monitoring and reporting for safety requires
additional resources which would prove to be a
strain for medical device manufacturers.
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Compliance

• The new MDR presents some disruptive changes that
  have far reaching implications for medical device
  manufacturers.
• With the transition period almost at end, there
  are several modifications that device
  manufacturers need to enforce to ensure success
  of existing and new devices.
• The extent and intricacy of the challenge
  presented by the new MDR would require device
  manufacturers to bring about substantial changes
  in domains as vast as data reporting, product
  development, manufacturing procedures and quality
  assurance.
• To comply with the new MDR, device manufacturers
  can strategize and conduct a gap analysis to
  identify whether their existing devices comply
  with the new MDR.
• Excellent leadership is vital to facilitate the
  smooth transition to the new MDR while developing
  a strategy for execution that comprises of
  preset timelines and techniques to monitor
  progress with regards to compliance.

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Medical device manufacturers could setup a core
leadership team that would include experts from
quality assurance, clinical or medical affairs,
R D, regulatory affairs, manufacturing,
labeling, biocompatibility, sterilization and
marketing. Members of the team need to establish
an active communication with NBs while setting
project harmonization between product portfolios
and business units (Premier Research, 2019). On
the other hand, medical device manufacturers are
approaching external entities (Contract Research
Organizations) to acquire support and guidance
to ensure compliance (Lehmann, 2019).
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