Over the past few decades the regulation of the safety of
medical devices has remained relatively unchanged. However,
today's medical devices are becoming ever more sophisticated
and innovative and existing rules have not kept pace with
scientific and technical developments. Moreover, the 2011 silicone
breast implant scandal and produce recall of the metal-on-metal
hip, highlighted serious weaknesses in the current regulatory
system and strengthened the case for modernising current rules for
medical devices. Following several years of negotiation, new
legislation was agreed by all member countries in June 2016 and
will become law in late 2019 or early 2020. This week's
blog, by Fiona Maini and Sarah Chan from our Risk and Regulatory
practice explores the implications of the legislation for the
medical devices industry.
The new requirements of the medical devices regulation
The new medical devices regulation (MDR) requires increased
scrutiny of products before they enter the market and tighter
surveillance once they are in use. It also requires the
establishment of a unique device identification (UDI) system to
ensure full compliance and traceability; whilst making it easier to
recall faulty products and to help fight against counterfeit
In terms of device product types, the approved legislation will
strengthen the information and
ethical requirements for diagnostic medical devices including those
used in pregnancy or DNA testing.
regulate the raft of products that
are currently unregulated, such as contact lenses and liposuction
increase the scrutiny of high risk
devices, such as implants, joint replacements or vascular stents,
which will require additional assessments by experts before they
can be authorized.
What to expect
Currently, high risk medical devices can be approved if they are
able to demonstrate clinical and safety equivalence to an approved
product on the market. However, the new regulation sets to make
market approval more difficult by requiring additional clinical
trials whilst also measuring more relevant outcome data. This in
turn, should help ensure a more coherent and robust structure for
the governance of high risk devices. The changes include:
introduction of post-marketing
requirement to have a 'qualified
person' responsible for regulatory compliance
creation of a EU portal where
manufactures must report serious incidents and corrective actions
taken to reduce the risk of recurrence
a new medical device coordination
group with the power to review and comment on NB assessment of high
greater transparency for patients
(especially clinical trial participants)
unique device identification
single registration numbers for all
safety and clinical performance
summaries for medical devices and IVDs.
Implications for medical device companies
These new changes that govern the medical device sector in the
EU represent one of the most disruptive and sweeping changes to
impact the whole industry. The EU MDR will lead to very significant
changes that will affect all devices currently being marketed in
the EU. Manufacturers will need to take a pro-active approach to
the new regulation and plan for the transition of existing devices
in a timely and meticulous way.
Before implementation in late 2019 or early 2020, there will be
a formal procedure whereby the regulatory text will be translated
for all EU member languages, followed by formal publication. After
publication, expected in late 2016 or early 2017, there will be a
three-year transition period.
Manufacturers should therefore start to evaluate the impact and
cost implications on their business and plan ahead for these
A step in the right direction
The EU has always been an attractive market for medical devices
manufactures due to shorter approval timelines and directives that
are less stringent and more innovation friendly compared with the
USA. The MDR aims to change none of that but rather bring the much
awaited rigor into a business which has been slow in responding to
and regulating growing types and complexity of medical devices in
last few decades and increasing demand for patient safety.
Regulatory changes have the ability create upheaval regardless
of the industry. Companies that stay ahead of the game and act
early will be in a position to maintain business as usual while
enjoying greater confidence in the safety and quality of their
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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