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, which is just around the corner. 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.
2.0 Objective of the New MDR
The new MDR has been passed with certain specific objectives
in mind. The key objective here is to make a two
dimensional impact in enhancing the safety of medical devices(Laege Middle Styrelsen, 2019), which are;
Reinforcing the rules associated with placing
new medical devices within the market.
Increasing surveillance post the device’s
availability in the market.
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). It has several implications and would
essentially mean that medical device manufacturers have to;
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. Manufacturers are
expected to adhere to stringent regulations with regards to performance,
quality and safety of medical devices that they provide.
3.0 Challenges for Medical Device
Manufacturers
Under the new MDR, 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.
Further, the process of clinical
monitoring and gathering evidence for recertification of existing products
could also prove to be an expensive proposition. Having said that, there are
four key challenges(Anastasi & Hill, 2019) that the new MDR poses for
medical device manufacturers and these would include;
3.1 Reclassification
As per the new MDR, 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. 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.
3.2 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.
3.3 High Demand for Notified Bodies
As of now, 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. However, 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.
Furthermore, 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.
3.4 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.
4.0 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.
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).
Anastasi, V., & Hill, K. (2019). The top four challenges under the new EU MDR and IVDR. Retrieved December 7, 2019
Laege Middle Styrelsen. (2019). New medical devices regulations. Retrieved December 7, 2019
Lehmann, J. (2019). Compliance In Focus. Retrieved December 7, 2019
remier Research. (2019). Strategic Planning for Compliance With the EU Medical Device Regulation. Retrieved December 7, 2019,
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