BCM International | EU Representative Service

Why not appoint your distributor?

Many distributors will offer to act as your EC-Rep for a nominal fee or even free of charge.
This may seem a very attractive option but there are many reasons why this is not such a good idea. Don’t forget, as a medical device manufacturer, you have many legal obligations. Often the distributor’s only objective is to sell as many products as possible. You need to consider that there may be a conflict of interest here.

Your EC-Rep’s name and address must appear on the product labelling. If you choose to switch to a new distributor, this will mean expensive artwork changes for EVERY PRODUCT!

Your distributor may also act on behalf of your competitors. As your EC-Rep he will need access to your confidential technical information. Is this such a good idea?

Most importantly, your EC-Rep needs to have a thorough knowledge of European Medical Device regulations. At BCM International, we have this knowledge and will use it to ensure that you always comply with the law. Can you be sure that you distributor will do the same?

Our commitment to you

When we act as your Authorised Representative, we commit to the following as a minimum:

To act as your Authorised Representative within the European Community with regard to the manufacturer’s obligations under the Medical Device Directive 93/42/EEC, Active Implantable Medical Devices Directive (90/385/EEC) and/or In Vitro Diagnostic Medical Devices Directive (98/79/EEC).
To pass on all communication from the EC Competent Authorities to your key contact within 72 hours of receipt.
To hold current copies of your CE and ISO 13485 certificates and Declarations of Conformity for agreed products.
To provide information relating to the agreed products to the relevant Competent Authority promptly upon request.
To report adverse incidents to the relevant Competent Authority as instructed by you.
To provide up to one hour’s regulatory consultancy each month (non accumulated) with respect to your obligations under the Directives.
To assume responsibility for co-operating with a Competent Authority in the event of you failing to take action when the Competent Authority has ordered corrective action. This may include the withdrawal of a product from the market (product recall) without prior approval of the manufacturer. (e.g. under 93/42/EEC Article 18 (a)).

We may also agree additional services such as complaint handling, product registration, vigilance reporting and recall handling if you need them.

Your commitment to us

As our client, we would expect you to agree, as a minimum:

To sign and keep up to date the Declaration(s) of Conformity for the agreed products listed in and to provide a current copy of the Declaration(s) to us.
To achieve and maintain ISO 13485 certification and to provide us with a current copy of the certificate.
To achieve and maintain CE certification from a Notified Body for all medical devices which require third party certification. To provide us with a current copy of the CE certificate(s).
To maintain up to date Technical Documentation for the agreed products and to make this available to us at the request of a Competent Authority or Notified Body within 72 hours.
To label all agreed products with our contact details and to provide us with a current copy of the labelling, including instructions for use.
To maintain internal procedures for complaint handling, adverse incident reporting, post market surveillance, product recall, advisory notice issue and significant change notification and to provide us with current copies of these.
To provide us with any information requested with respect to a complaint or adverse incident investigation such that the information may be provided to the Competent Authority to ensure regulatory compliance.
To provide us with details of any adverse incidents, product recalls or advisory notices relating to agreed products at regular intervals.

Contact Us

Contact us now for a confidential discussion regarding your requirements. We recognise that each company is unique and don’t therefore have a “one size fits all” approach to our service. We will put together a proposal for you based on your individual requirements that exactly meets the needs of your organisation.

Email info@bcminternational.co.uk or telephone +44 7928 405062