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Your Authorized Representative - "Made in Germany"
CE – marking for medical devices
You need to know how you can obtain CE-marking for your devices?
You are unsure as to which conformity assessment route would best
suit your individual requirements?
click here to learn more
Authorized Representative in accordance with
MDD 93/42/EEC (2007/47/EC) & IVDD 98/79/EC and others
What exactly is an Authorized Representative?
What is important for a manufacturer when choosing an Authorized Representative?
click here to learn more
Consultancy: EU Regulatory Affairs
Which rulings do you need to bear in mind over and above the well known medical device
Directives?
What is the status in the EU with regards to the enhancing environmental legislation?
Are your products effected?
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Benefit from additional services provided by our strategic network partners:
Identification of distributors, Professional translation services, FDA/510k approvals,
Chinese market approvals, WEEE registrations
click here to learn more |
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June NEWS
“Compliance is just as crucial as Innovation and Growth”: feedback from the International
Medical Device Industry Compliance Conference
Are EU regulators trying to slate the device industry?
Much needed standards are crucial as technology advances at a rapid pace
Phthalate labelling symbol included in OJ list of harmonised standards
Contact us for more information at:
info@mdi-europa.com
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