Europe
With many years of regularatory experience for CE marking and medical device specific expertise, we are able to guide you through all conformity evaluation procedures in accordance with AIMD (Directive on Active Implantable Medical Devices 90/385/EEC), MDD (Medical Devices Directive 93/42/EEC) and IVD (In Vitro Diagnostic Directive 98/79/EC).
European Authorized Representative (EAR)
A manufacturer based outside of the European Union who intents to sell medical diveces onto the European Market, the legislation requires the appointment of an Authorized Representative within the European Union who represents the foreign manufacturer in contacts with regulatory authorities and responsibility outlined in the directives.
A manufacturer who places a medical device on the market must designate “a single authorised representative in the European Union” if he does not have a registered place of business in EU (AIMDD Art 10a(2), MDD Art 14(2)).
Medical Device Directive 93/42/EEC on Medical Devices
Annex I:
Essential Requirements
Annex II:
Full Quality Management System
The manufacturer has a quality management system, e.g. in compliance with EN ISO 13485:2003, fulfills the additional requirements of the Directive (e.g. market surveillance, reporting, document storage, fulfill ment of the essential requirements as laid down in Annex I) and declares the conformity of his products with
the Directive. In the case of devices belonging to class III, a product design review is also stipulated.
Annex III:
EC Type-Examination
A Notified Body carries out a type-examination according to the essential requirements of Annex I of the Directive and issues a type examination certificate.
Annex IV:
EC Verification
A Notified Body tests the products in the final production phase, either by checking all products or by means of random samples on a statistical basis.
Annex V:
Production Quality Assurance
The manufacturer has a quality management system for his production, testing and final inspection, e.g. in compliance with EN ISO 13485:2003 (see Annex II).
The requirements regarding Design and development are excluded.
Annex VI:
Product Quality Assurance
The manufacturer has a quality management system for the final product inspection and testing e.g. in compliance with EN ISO 13485:2003 (see Annex II). The requirements regarding Design and development, Control of production and service provision and Validation of processes for production and service provision are excluded.
Annex VII:
EC Declaration of Conformity
The manufacturer issues a declaration of conformity without involving a Notified Body. He is, however, obliged to provide a technical documentation stating that the product fulfills the valid requirements, and he must have installed a system for market surveillance (vigilance system), reporting, document storage, etc.
Contact
ECURAC - EU / China / US Regulatory Affairs Consultants
European Union
+49 89 21550998
China
+86 131 6119 7082
United States
+1 805 570 6135
info@ecurac.com
European Union
+49 89 21550998
China
+86 131 6119 7082
United States
+1 805 570 6135
info@ecu