[cryout-multi] [cryout-column width=”2/3″]Key points to look for:
- It’s important to understand the role of an authorised rep and which responsibilities you need to delegate. Minimum requirement would include incident reporting, product recalls, complaint handling, and post-market feedback
- Services vary with experience, but most will offer a custom service contract to suit your needs. Personal chemistry, experience and fees will determine the right authorised representative for your business
- European regulations and vigilance can be complicated, so look for an authorised representative with considerable European regulatory experience with medical devices or IVDs. It’s not essential for them to have expert knowledge of your device and technology, but they should be able to guide you through the regulations and requirements that apply to your device
- An area where an experienced authorised representative is particularly important is when dealing with class I devices. As class I devices are self-certified where the product is non-sterile or does not perform a measuring function, it is important that your authorised representative has the appropriate skills and experience to ensure the classification process has been correctly followed and the technical file is adequate. This will help avoid issues with mis-classification or registration with competent authorities
- Provide legal awareness service in respect of legislative changes impacting the business and market of relevant EU member state
- It’s important for both of you to have a clear contract that stipulates all duties and responsibilities as manufacturer and authorised representative
Pitfalls of using a distributor as your authorised representative
Distributors may not be aware of the role and responsibilities of authorised representatives and would lack the regulatory experience to advise on interpreting new European laws. Would you rely on your distributor keeping abreast of legal changes and how they could affect your business?
Consider also your distributor’s name and address will be on all of your materials, no matter where they are sold in Europe. If you decide to change distributors, you will have to reprint all your labels, manuals, packaging, and presented with a potential challenge on how to deal with products on the market that have that distributor’s name on them. If you choose one distributor among several to be your authorised representative, such an arrangement may create resentment among your other distributors.
If your distributor acts as your authorised representative, they will have full access to your technical files, which should include proprietary information such as manufacturing methods and critical suppliers. There could also be issues arising out of recall and (near) incident reporting. If the competent authorities question an incident or a case of noncompliance with your product, can you be sure your distributor will defend your company or safeguard their own interests?