QNET B.V. offers European Union Authorized Representative services under the Medical Device Directive 93/42/EEC, In-Vitro Diagnostic Medical Devices Directive 98/79/EEC and the Machinery Directive 2006/42/EC.
Medical device manufacturers require a European Authorized Representative in accordance with the Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC; "Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative".
Frequently asked questions about the role of the European Authorized Representative can be read here.
To obtain an Authorized Representative proposal for a Medical Device or IVDD please complete the application online by clicking HERE.
Austria is introducing a new tax system on medical devices which must be paid for the first time by June 2012 for the year 2011. This tax payment is used by the Austrian Competent Authority (Austrian Federal Office for Safety in Health Care) to monitor the medical devices market and carry out its notional vigilance (read:enforcement) responsibilities.
It will be a single fee which must be paid by any person or organization who delivers a medical device to a final consumer (or end user) in return for payment. This includes renting or leasing of medical devices.
The tax rate is based on risk classification as follows:
Risk Class 1 medical devices, €250, (Approx. US$355)
Risk Class IIa medical devices and self-testing IVDs, €300, (Approx. US$413)
Risk Class IIb medical devices and IVDs in Annex II list B, €350 (Approx. US$482)
Risk Class III medical devices, IVDs in Annex II list A, Active Implantable medical devices. €400 (Approx. US$550)
Companies supplying multiple risk classification of devices will only need to pay the highest tax, and not a total of all the taxes together. Larger companies with several establishments will only have to pay a maximum of €2,000, (Approx. US$2,753) in total.
Risk Class I medical devices no longer need to be registered in Italy if the manufacturer or his Authorized Representative has registered the device in another EU Member State.
How did this happen?
The US Department of Commerce's International Trade Administration (ITA) received complaints from QNET (on behalf of all of its Authorized Representative clients) and Advamed (1600 members). ITA successfully communicated these complaints to the EU Commission.
In response to the EU Commission's pressure, Italy adopted a new decree which brought about: 1) lifting of the Risk Class I registration requirement (if already registered in another EU State) and 2) a much streamlined registration process for the higher risk class devices.
Result:
With the assistance of the ITA, QNET helped bring about savings of US$600-800.00 per device for its clients.
A prime example of how a committed Authorized Representative company can serve its clients in the EU.
For further details Click here for the Department of Commerce Letter.
Croatia will become the 28th Member State in 2013 and has decided that Labels and Instructions for Use must be in the Croatian language. This means that your correctly CE-marked devices, machinery and other products may be place on the Croatian market.
New MEDDEV guidance document MEDDEV 2.12/2 rev.2 has been published covering Post Market Clinical Follow-up. This document can be downloaded here.
MEDDEV 2.1/6: Guideline on the Qualification and Classification of Stand-alone Software Used in Healthcare within the Regulatory Framework of Medical Devices can be downloaded here.
Effective December 29, 2009 all non-European based machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturer's technical file or have quick access to it. The Authorized Representative must have received a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term 'Authorized Representative does not describe a sales and marketing function, it describes a CE compliance/regulatory affairs function only.
The EU Commission is strengthening its surveillance and enforcement of the CE Mark program and requires that the first point of contact is the manufacturer's European Authorized Representative.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information. It is therefore of great importance to appoint an established and knowledgeable EU Authorized Representative firm in accordance with an EU legal agreement than includes confidentiality.
To obtain an Authorized Representative for Machinery proposal please complete the application online by clicking HERE.
Croatia will become the 28th Member State in 2013 and has decided that Labels and Instructions for Use must be in the Croatian language. This means that your correctly CE-marked devices, machinery and other products may be place on the Croatian market.
Headquarters:
QNET LLC
P.O. Box 527
Elk River, MN 55330
Telephone: 763-441-0899
E-mail: qnet@ce-authorizedrepresentative.eu
The Netherlands:
QNET BV Hommerterweg 286
6436 AM Amstenrade, The Netherlands
KvK Zuid-Limburg 14091511
Assisting manufacturers with CE Marking of medical devices and machinery since 1996
QNET LLC CE Mark for Medical Devices and Machinery
FDA USA Agent for medical device manufacturers outside the USA
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