Pursuant to MDD 93/42/EEC Article 14: If a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, then he shall designate a single authorised representative in the European Union.
Pursuant to MDD 93/42/EEC Article 1: The manufacturer is the natural or legal person
with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market
under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
Pursuant to MDD 93/42/EEC Annex I, Chapter I, Sections 13.3(a) and 13.6(a), the label and, where appropriate, the directions for use, must bear the manufacturer's name and address
as well as the name and address of the manufacturer's authorized representative.
Deciding who is the "manufacturer" can sometimes seem a little tricky. But the most straight-forward scenario is where the manufacturer is the one who owns/controls the design. Such a manufacturer typically puts his own name on the labeling instead of a third party's, even if the product is contract-manufactured on his behalf by a third party. In that scenario, the contract manufacturer doesn't need to be identified on the label.
By comparison, there is an arrangement traditionally called "own-branding" wherein the own-brander's name appears on the label, thus making him the "manufacturer" even though such entities are oftentimes just wholesalers with no manufacturing expertise or capabilities at all. For many years there was a relatively abbreviated approach to complying with 93/42/EEC in this scenario. But the European Commission's October 2013 Recommendation 2013/473/EU "significantly amended expectations for manufacturers who don't design or manufacture devices but place their names on the product as the manufacturer" (MHRA March 2017). If that is your scenario, then you may want to provide us with more details so that the forum can comment accordingly.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.comCopyright 2017 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 13-Nov-2017 19:28
From: Rashmi Pillay
Subject: CE authorised rep address
Hi,
For marketing a class I medical device in EU , is it necessary to have the CE authorised rep address?
This device is manufactured by a third party manufacturer for us. The labelling mentions the manufacturer as the third party .This manufacturer does not have a authorised EU rep. Is it necessary to have our EU rep address instead or is it not necessary ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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