Why do you need an Authorised Representative?

The European Directives for Medial Devices (93/42/EEC), Active Implantable Medical Devices (90/385/EEC), and In Vitro Diagnostic Medical Devices (98/79/EEC) require the appointment of an Authorized Representative (EC-Rep) for non-European manufacturers who wish to sell their devices in Europe.

The EC-Rep represents the manufacturer to the national Competent Authorities and is the holder of (or has rapid access to) all necessary technical documentation for the devices in the marketplace.

BCM International is a dedicated Authorised Representative who will ensure that your devices are marketed legally within the European Union and deal with all regulatory issues promptly and effectively on your behalf.

BCM International will provide you with all the help you need to meet EU Medical Device regulations, for the entire lifecycle of the product. With our main office in the UK and affiliates in the USA, South Africa and Asia we are able to provide you with a personal service tailor made for your company.

We can also provide you with the advice and guidance you need to get your product onto the European market, even if you haven’t yet started the process. Our sister company, ACQC Limited is a quality management consultancy that specialises in quality management system creation, technical file construction and Notified Body approval processes.
Contact us and we will take you all the way to market.