EU Authorized Representative under the Medical Device Directive 93/42/EEC, IVD Directive98/79/EC and the Machinery Directive 2006/42/EC, Personal Protective Equipment Directive 89/686/EEC, ATEX Directive 2014/34/EC, Pressure Equipment Directive 2014/68/EU.
Authorized Representative for CE marked Medical Devices and CE marked In-vitro Diagnostic Devices
Medical device manufacturers located outside the European Union are required to have a European Authorized Representative in accordance with Medical Devices Directive 93/42/EC and IVD Directive 98/79/EC.
Frequently asked questions about he role of the Authorized Representative can be found here.
To obtain a an Authorized Representative proposal for a Medical Device or IVD please complete the application by clicking here.
Authorized Representative for CE marked Machinery, PED and PPE.
Effective December 29, 2009 all machinery, Pressure Equipment, ATEX and Personal Protective Equipment manufacturers located outside the European Union are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturers technical file or have quick access to it. The Authorized Representative must have a written mandate (agreement) from the manufacturer before its name appears in 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.
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 that includes confidentiality.
Frequently asked questions about he role of the Authorized Representative can be found here.
To obtain an Authorized Representative proposal for Machinery, PED or PPE please complete the application by clicking here.
2015 QNET BV AR Notices:
Moldova Accepts CE Marked Medical Devices
Update on Harmonized Standards
De-designation of and Complaints about EU Notified Bodies
Risk Class I EU Market Surveillance Project
Notified Body Warnings to prevent a crisis
Status of New Medical and IVD Regulations
2014 QNET BV AR Notices:
RoHS Directive 2011/65/EU-July 22,2014 deadline-documentation required
Revision of Medical Device Directive 93/42/EEC: Qualified Person
Transition Planning for ISO 13485:201X-3rd revision and ISO/DOS9001:2014
QNET BV CONTACT INFO:
Telephone: 1.763.441.0899
E-Mail: QNET BV Primary email
E-Mail: QNET BV secondary email
