LRQA Guidance How to launch your Medical Device into Europe

LRQA Guidance
How to launch your Medical Device into Europe
Determine Classification of Device
Correct classification of your device is important, use Annex IX of the Medical Devices Directive (MDD).
Class 1
Non-sterile
Nonmeasuring
Class 1
Sterile
or
Measuring
Class IIa
Class IIb
Our field-based Account Managers,
together with our product conformity
team, offer support and guidance.
Class III
Implement a Quality Management System
Annex II or V of the MDD, requires manufacturers to implement
a quality management system (QMS).
Prepare a Technical File
For all device classifications, manufacturers are required to demonstrate their
compliance with the MDD, 93/42/EEC.
Device Classification
Under MDD 93/42/EEC, LRQA is a
notified body for medical devices using
the quality system conformity routes –
Annexes II and V.
Prepare
Design
Dossier
Required for
all Class III
devices
Appoint an Authorised Representative
If manufacturers are based outside the EU, they must appoint a
representative located in Europe who is qualified to deal with regulatory issues.
CE Marking Process
LRQA provides certification services to
the international quality standard
ISO 13485. This standard has been
modified from ISO 9001, to make it
more appropriate for medical device
manufacturers.
LRQA has also been assessing to
the MDD since 1994, and we hold
notified body status for over 15 EC
product directives.
With nearly 20 years’ experience as a
notified body, LRQA has established
an in-depth knowledge of
certification within the medical device
sector. With our experience of QMS
and CE marking, we can help ensure
you meet regulatory requirements.
Prepare and Finalise Declaration of Conformity
This is a legally binding document prepared by the manufacturer stating
that the device complies with the applicable Directive.
Audit QMS and Technical File or Design Dossier
Upon successful completion of the audit by a notified body,
a CE certificate for the device will be issued.
Register Class I Devices
These must be registered with a
competent authority where the
EC REP is based.
Certification
The two-stage certification process for
CE marking ensures you have a quality
system that meets the requirements of
the conformity annex applied and is
implemented for the manufacture of the
medical device concerned.
Class IIa, IIb and III Devices Registration
Most EU countries do not require registration of
Class IIa, IIb or III Devices.
Affix the CE mark
Surveillance visits
Once approved, we will regularly review
your system and sample your technical
files to ensure you remain compliant with
the requirements of the directive and
standard.
LRQA offers guidance through the CE marking process, call 0800 783 2179 or email [email protected]
Business Assurance
Ever tougher stakeholder demands,
changing business conditions and
increased competition means you need
better operational control, performance
and risk management.
To help you, we continue to enhance
our services. We don’t just verify against
the requirements of a standard, but go
even further.
Our field-based account managers tailor
our certification, validation, verification
and training services to better meet your
needs, giving ‘added value’ beyond the
traditional assessment process.
LRQA Business Assurance helps
you to manage your systems and
risks to improve and protect the
current and future performance
of your organisation.
Why choose LRQA?
With nearly 20 years experience as a
notified body for the MDD, LRQA has
established an in-depth level of knowledge
and understanding of certification within
the medical devices sector. With our
experience of quality management systems
and CE marking, we can help ensure that
you meet regulatory requirements.
We call this enhanced emphasis and
approach, ‘Business Assurance’.
Our involvement in national and European
working groups gives us access to a wealth
of information, enabling our dedicated
Your next step
• Starting point – before making an
application you need to be able to
answer these questions:
- Are you a manufacturer as defined in
the directive and responsible for
placing products on the market?
- Are your products medical devices?
- What is the classification and your
chosen conformity route?
Our team is on hand to offer support
and guidance on any of these points.
• Optional gap analysis – this assessor
delivered activity offers the opportunity
to focus on critical, high risk or weak
areas of your system in order to create
a certifiable system. It can also look at
how existing management systems or
procedures can be used within your
chosen standard.
• Application – you will need to
complete a simple form letting us
know about your company and your
products. We will use this information
to verify the requirements relating to
your products and to work with you
to determine the best options for
conformity assessment including any
other service we can help you with.
• Ready for assessment? – unsure
whether you are ready for the formal
certification? Choosing our optional gap
analysis will give you the confidence to
go for certification.
Whether you are in the early stages of
implementing your management system
or looking to go for a ‘dry run’ before
the assessment visit, the scope
of the ‘gap analysis’ can be decided
with either your account manager or
assessor and gives you more flexibility
in choosing the scope and duration of
the visit.
• Certification – the formal two-stage
certification process for CE marking
ensures you have a quality system
that meets the requirements of the
conformity annex applied and is
implemented for manufacture of the
medical devices concerned.
product conformity team to keep
customers up to date with the latest on
current and future developments. This
helps you plan for the future and to make
the most of the market opportunities
available to your business.
Our assessors will provide consistent
and constructive audits to help ensure
that your system delivers tangible
business benefits, while giving you the
confidence that your system meets
regulatory requirements.
Choosing LRQA means you’ll be
working with one of the world’s
most trusted and respected
management system bodies providing
you, your customers, prospective
customers, trading partners and other
stakeholders, with business assurance.
In addition, the certification assessment
can, if requested, be used to assess
the quality system against recognised
QMS standards, such as ISO 9001 and
ISO 13485.
The assessor will establish that you
have correctly identified which essential
requirements apply to your products,
have fully integrated the requirements
into the QMS system and have taken
the necessary steps to draw up the
technical documentation.
• Surveillance visits – once approved,
we will regularly review your system and
sample your technical files to ensure
its ongoing effectiveness and that you
remain compliant with the requirements
of the standard and the directive. This
gives you, and your top management,
the assurance the management systems
are on track and continually improving.
T
0800 783 2179
E
[email protected]
W www.lrqa.co.uk
Lloyd’s Register Quality Assurance Ltd
Hiramford, Middlemarch Office Village, Siskin Drive, Coventry CV3 4FJ, UK
Lloyd’s Register Quality Assurance is a member of the Lloyd’s Register Group
Registered office: 71 Fenchurch Street, London EC3M 4BS
Registered number: 1879370
Lloyd’s Register and LRQA are trading names of the Lloyd’s Register Group of entities.
Services are provided by members of the Lloyd’s Register Group. For details, see www.lr.org/entities
Care is taken to ensure that all information provided is accurate and up to date.
However, LRQA accepts no responsibility for inaccuracies in, or changes to, information.
© LRQA 2011 - Lloyd’s Register Quality Assurance Ltd - All rights reserved. Pub. Oct 2011