Finding an experienced Authorised Representative is one of the most important factors to consider when selecting one. Having someone who has demonstrated capabilities and a good track record with other companies in your industry will keep you assured that your products are being taken care of and are following the correct protocol.
Regardless of your product, you should look for an AR who has considerable European regulatory experience with the applicable industry. European regulations and diligence can be complicated, and your Authorised Representative should have experience with a wide range of devices. When talking to different Authorised Representative providers, your Authorised Representative need not always have to have the expert knowledge of your product and its technology, but they should be able to guide you through the regulations and requirements that apply to your product.
At the heart of your relationship with your Authorised Representative should be trust. They should have a good reputation, be reliable, and have strong credentials. This is crucial considering the fact that liability for any wrongdoings or negligence of duty in relation to your products could be very damaging to your company and its reputation.
In order to ensure trust, consider including a trial period in the contract agreement to ensure that a good working relationship is established before committing long-term. This protects both the interests of you as the company and of them as an Authorised Representative and can ensure that a sustainable long-term relationship is formed.
Monitoring and complying with European regulations can be challenging and takes a good level of diligence and staying on top of things. European officials continue to tighten regulations regarding diligence and the responsibility to ensure this is maintained.
Depending on the type of product you are placing onto the market, it is either up to the manufacturer or Authorised Representative to ensure that the product complies with applicable standards and directives. It is therefore imperative to choose an Authorised Representative who has strong connections in Europe, who stays on top of changes in regulatory affairs, and who makes your representation needs their first priority.
Authorised Representatives are often required to act on the behalf of a company in proceedings with various National Competent Authorities (NCA’s) and are required to undertake post-market surveillance activities which should adhere to European legislation. It is therefore important that the appointed Authorised Representative is very professional and is able to act with a strong level of confidence and assertiveness in their role. They are, after all, representing your company to these authorities.
Finally, an Authorised Representative with a broad understanding and knowledge of the industry and what it means to be an Authorised Representative is crucial to take into account when selecting an Authorised Representative. At the end of the day, you need a representative who can confidently handle all matters relating to important documents, representation to competent authorities, post-market surveillance activities, and compliance with European law. Without in-depth knowledge of these components, the workload will end up falling on your company and the relationship will be counterproductive.