Medilink North of England News 2019 Medilink NOE News 2019 | Page 10

GLOBAL MEDICAL DEVICE
& IVD REGULATIONS:
WHAT YOU NEED TO KNOW
MEDILINK CLINICAL
EVALUATION REPORT
(CER) STRATEGY AND
GAP ANALYSIS SERVICE
Before launching your medical device onto the
European market, it is essential to make sure that
it fully complies with MEDDEV 2.7.1 Rev 4 and the
new Medical Device Regulation (MDR). To achieve
this, you need a Clinical Evaluation Report (CER)
which would present sufficient clinical evidence
to support the indications and claims you are
making.
Producing a CER is a key part in maintaining the
CE mark for existing products and in securing CE
marking for new products. Your CER should also
demonstrate that the benefits of using the device
outweigh any potential risks.
Writing a CER is a substantial undertaking -
it can take an enormous amount of internal
resources to create and needs regular updating.
As experienced authors of CERs for Class I, IIa,
IIb and III medical devices, Medilink’s Innovation
and Commercialisation experts can advise you on
how to address gaps in your evidence and ensure
continued compliance with the legislation. Our
team will also help you increase your chances of
launching your product onto the market at first
attempt.
Enhancing your CER could effectively improve the
profitability of commercial adoption to drive future
sales.
Contact the Medilink Innovation and
Commercialisation team today to discuss
your clinical evaluation report and receive
professional guidance - 0114 232 9275.
10
Medilink North of England held its Global Medical
Device Regulations event on 9th July to help
members and industry professionals to fully
understand the new industry standards. Two years
after the new European MDR and IVDR regulations
were announced and with 10 months to go until they
are implemented, many businesses admitted they
have still not started the transition of adopting the
new standards.
Welcoming more than 80 delegates to the Liverpool
offices of Medilink Corporate Partner Hill Dickinson,
the event showcased the knowledge and expertise
of 10 speakers, covering topics including changes to
EU regulation, Brexit, and other global regulatory
opportunities. Damon Williams from BSI offered
clarity on some of the major revisions within MDR and
IVDR and answered questions from many businesses
still unsure about how the changes will affect them.
Kevin Kiely, CEO of Medilink North of England said
“With so much change occurring in a short amount
of time and an overwhelming demand from our
members, this event allowed companies to learn
from each other and share experiences of the
practical implementation of global medical device
regulations.”
Tom Wright, Medilink Innovation and
Commercialisation Manager gave advice on the
importance of clinical evidence, and representatives
from the Office for Life Sciences offered guidance on
Brexit, and how companies can prepare for trading
with or without a deal. Medilink members, Abingdon
Health, Paxman Coolers, and Perfectus Biomed
offered ‘real life’ case studies to delegates based on
their experiences in dealing with the IVDR changes
and gaining FDA approval respectively.