We can provide you with TOTAL REGULATORY PEACE OF MIND!
AUTHORIZED REPRESENTATIVE SERVICES
Medical
Device 
&
QA Consultancy
FOR MANUFACTURERS of MEDICAL DEVICES (93/42/EEC) &
IN VITRO DIAGNOSTIC DEVICES (98/79/EC)
who are BASED OUTSIDE EUROPE
What is the definition of the "Authorized Representative"?
In the Medical Device Directive (93/42/EEC), there is no definition of the Authorized Representative. Only when the IVD Directive (98/79/EC) was published in December of 1998, did the following 'official' definition become available;
‘authorized representative’ – means any natural or legal person established in the community who, explicitly designated by the manufacturer, acts and may be addressed by the authorities and bodies in the community instead of the manufacturer, with regard to the latter’s obligations under the medical device directive 93/42/EEC or in vitro diagnostic directive 98/79/EC.
Why is an Authorized Representative necessary?
If
you "Place Medical Devices on the Market" in Europe and your
Manufacturing facility is located outside Europe, then you must have an
Authorized Representative within Europe, to communicate and deal with
Competent Authorities on your behalf.
(Article
21- IVD Directive amendment to MDD 93/42/EEC))
Our
Authorized Representative Policy is….
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To
represent all our Clients best interests, in an honest and
professional manner, at all times. |
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To
provide help and assistance to enable all our Clients to meet their
Regulatory responsibilities effectively and at a minimum cost |
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To
provide information and guidance on the latest interpretations and
decisions of the Regulatory Bodies in Europe |
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To
provide our Clients with the opportunity to benefit from Industry
Best Practice,
through our experience working with European Notified Bodies, on a
regular basis |
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To provide all the above, at a fair and reasonable cost. |
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To
continuously Improve the Service that we provide. |
What does our Authorized Representative Service provide for your Company?
Medical Device & QA Services offers a comprehensive partnership arrangement to ensure your complete Peace of Mind, in the knowledge that all your Regulatory Responsibilities and Best Interests are being Professionally looked after, continuously.
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Comprehensive Authorized Representative Service, at a minimum fixed cost |
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Assistance to meet WEEE and RoHS Directives |
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General
help and advice with other Regulatory Issues such as Packaging
& Waste, Low Voltage Directive, EMC etc |
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Marketing
Support |
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New product Design, Development and Marketing |
Some
of the issues that an Authorized Representative would be involved in are;
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Registration of your "Professional Use" IVD's with Competent Authorities |
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Registration of your "Self Test" IVD;'s with Competent Authorities |
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Liaison with your Notified Body, as appropriate |
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Registration of the Manufacturer
and their Products, with appropriate Competent Authorities |
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Registering Products under the
Class I Self Certification Route |
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Registering Products under Article
12. Self Certification Route |
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Liaison with Distributors to
ensure effective Feedback |
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Adverse and Near Incident
Reporting, on behalf of the Manufacturer |
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Early Warning Post Market
Feedback system implementation |
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Product Recalls and Issue of Advisory Notices |
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We
will give you SAMPLE PROCEDURES if you need them, to ensure that you
meet all the POST SALES ISSUES, as part of the agreement. |
NEXT STEPS....
View a typical Technical Agreement
e-mail Bernard Tremaine on any Medical Device issue
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