Why you need a Representative in the EU and/or UK
The European Directives for Medical 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 Authorised Representative (EC-Rep) for non-European manufacturers who wish to sell their devices in Europe. This requirement is even more clearly defined in the new European Medical Device Regulations, 2017/745 and 2017/746 and will also apply to UK manufacturers post-Brexit.
When the UK leaves the EU, you will also need a UK Representative (Responsible Person) if you are outside the UK.
The EC-Rep and the UK-RP will represent the manufacturer to the national Competent Authorities and will be the holder of all necessary technical documentation for the devices in the marketplace.
Annette Callaghan (UK) Limited and Annette Callaghan (Ireland) Limited can provide a dedicated EU/UK Representative service, to ensure that your devices are marketed legally within the European Union and the United Kingdom, and deal with all regulatory issues promptly and effectively on your behalf.
Annette Callaghan (Ireland) Limited will provide you with all the help you need to meet EU Medical Device regulations, for the entire lifecycle of the product. Annette Callaghan (UK) Limited will off the same service in relation to the new UK Medical Device Regulations published in April 2019. With our main offices in the UK and Ireland and affiliates in the USA, Canada, Australia 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 UK and European markets, even if you haven’t yet started the process. We also specialise 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.
Why not appoint your distributor?
Many distributors will offer to act as your EC-Rep or UK-RP 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. 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 they may have a conflict of interest.
Your EC-Rep’s name and address must appear on the product labelling (although this is not yet a requirement for the UK-RP). If you choose to switch to a new EU distributor, this will mean expensive artwork changes for EVERY PRODUCT!
Your distributor may also act on behalf of your competitors. As your EC-Rep or UK-RP they will need access to your confidential technical information. Is this what you want?
Most importantly, your EC-Rep/UK-RP needs to have a thorough knowledge of European and UK Medical Device Regulations. At Annette Callaghan (UK and Ireland) Limited, we have this knowledge and will use it to ensure that you always comply with the law. Can you be sure that your distributor will do the same?
