Why you should NEVER appoint a distributor as your Authorized Representative -- MEDICA - World Forum for Medicine


Obelis O.E.A.R.C.

Why you should NEVER appoint a distributor as your Authorized Representative

• As per the Directive, the E.A.R must keep available for the European Authorities the product’s technical file, do you feel comfortable giving your distributors such delicate information on your products such as your technical file- it should be kept with a neutral party.

• The E.A.R must be a professional one, allowing him to cope with any question, remark or crisis brought forth by any of the 27 EU member states competent authorities and still be able to act in your best interest.

• The E.A.R is to observe the day by day compliance of the manufacturer – only a professional and neutral authorized representative will be able to ensure your compliance while not having any conflict of interest with other commercial interests (or other).

• As per the directive, the E.A.R should represent you for the entire European community- as such he needs to be familiar with the European Directives but also with each of the EU member states national laws implementing the Directive in the country (Europe is NOT one country!). A distributor knows how to sell and does not know the regulation, not to speak of regulation of other European countries which he does not belong to nor wishes to take responsibility for!

• The European Directive is an ever changing “animal”- only a regulatory body which its business is to know the regulation will keep you updated & safe at all times - Not knowing the law will not save you from non-compliance and penalties - the sooner you will know about it the better your sales will be in Europe. • Your E.A.R is to act as your centralized focal point for any regulatory matter within the EU and act as your consultant at all times – Obelis will serve your distributors all over the European Union in reference to your products for no additional fees (your clients are our clients).

• If you let your distributor register your products for you – once you will enter into a commercial dispute with him you will need to re-register your products. • Letting your distributor place his name on your products will put your other distributors in an uncomfortable situation as one will be of a higher status than the others. • Letting your distributor place his name on your products will force you to reprint your labels if you decide to stop working with him – distributors may change very fast – your relations with your E.A.R must be stable and long-lasting!

In short – Let your distributor sell and let your E.A.R be your Regulatory partner in Europe.

The above are only examples of what a professional E.A.R should be able to do for you; we hope you will give hard consideration as to who is to be your regulatory partner in Europe as a Professional E.A.R is supposed to be exactly that.

Written By: Mr. Doram Elkayam - Obelis C.O.O.