So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, marketing, shipping, and distributing your medical devices. But wait, a host of regulatory issues still loom. One such issue that confronts all non-European manufacturers that sell devices in Europe is the appointment of an Authorised Representative. In their zeal to get products out the door, most people don't give it much thought, but there are good reasons why you should.
Essentially, an Authorised Representative (AR) plays an intrinsic part in post-market surveillance, including vigilance. The AR is your link to European authorities, and they must maintain physical presence in Europe. They will register your medical device or IVD before it is marketed, and will always be available to serve as a contact between you and the Competent Authorities of the EU member states. Your AR will also have access to your Technical File(s), which must be available for inspection by the Competent Authorities. In other words, a variety of the responsibilities of the manufacturer are delegated to the Authorised Representative.
The name, address, and telephone number of your AR must be placed on the information that accompanies your device, such as (packaging) labeling and instructions for use. In the event of an incident, your AR will assist and coordinate the reporting of the incident to the Competent Authorities, and will cooperate with you and your distributors to ensure that the proper reporting and follow up protocols are followed. In the event that your device is withdrawn from the market, your medical device Authorised Representative can represent you to the European Commission for consultation.
These are the tasks that you delegate to your representative to perform on your behalf. However, it is important to note that the AR is not legally responsible for non-conforming devices, unless the problem is a direct result of one of these tasks. The manufacturer should always responsible for the safety of the device. Some of the Member States' Competent Authorities however are of the opinion that the Authorised Representative can be held responsible for the device. This opinion provides a challenge for the Authorised Representative which has no control over design, manufacture, packaging and labeling of a device, otherwise the AR would be a manufacturer.
First of all, make sure you know exactly what the role is of the AR and which of the responsibilities you need to delegate. At minimum, an AR must be able to handle (near) incident reporting, product recalls, complaint handling, and post-market feedback. Each AR provides slightly different services, although many will custom tailor a contract for you, and obviously fees will vary. Determine which services you need, and how much you are willing to pay, and choose an AR who most effectively (and efficiently) can meet those needs.
Regardless of your product, you should look for an AR who has considerable European regulatory experience with medical devices or IVDs. European regulations and vigilance can be complicated, and your AR should have experience with a wide range of devices. When talking to different AR providers, your Authorised Representative need not always have to have the 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.
Considering the role of the AR, it is important to ensure that the responsibilities of both you, as the manufacturer, and your selected AR are clearly outlined and stipulated in a contract.
Some companies opt to use their distributor or importer as their Authorised Representative. Many distributors, however, may not be aware of the role and responsibilities of Authorised Representation. There are other issues to consider.
First, 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 of your labels, manuals, packaging, and are presented with a potential challenge on how to deal with the products on the market that have that distributor's name on them. Besides, if you choose one distributor among several to be your Authorised Representative, such an arrangement may create ill will among your other distributors.
Second, a distributor should focus on the sale and marketing of your devices, not on regulatory affairs. If the European laws and guidelines are modified, are you sure your distributor will keep abreast of these changes and notify you when changes affect your devices? In the regulatory affairs world, ignorance is not bliss.
Third, your distributor, as your Authorised Representative, will have access to your Technical File(s), which may include proprietary information. A related issue deals with recall and (near) incident reporting. If the Competent Authorities question an incident or a noncompliance that occurred with your product, can you be sure your distributor will defend your company...or protect their own interests? That being said, companies that sell Class I devices who only intend to sell in a few countries through a single distributor might try to save some money appointing the distributor as their AR. However, since the annual cost of appointing an AR is generally under US$3,500, you may want to weigh the risks versus benefits of such a decision.
Regardless of whether you decide to choose a distributor or an independent party as your AR, you should select someone who has some history in the business. If the company you select is only a few years old, they may end up going out of business. In that case, guess who pays the bill for reprinting Instructions for Use, labels and packaging? Furthermore, a company with more history and experience in the business may have stronger personal relationships with Competent Authorities, which may work to your advantage if problems arise.
European officials have begun, and will continue to, tighten regulations regarding vigilance. For example, IVD products will soon have to present more evidence of clinical trials before registering their products. Remember that the manufacturer must ensure that their devices conform to applicable standards and directives - neither your AR nor a distributor can guarantee this for you. Therefore, it is important to choose an Authorised Representative who has strong connections in Europe, who stays on top of changes in regulatory affairs, and who makes serving your representation needs their first priority.
Monitoring and complying with European regulations can be challenging. Choosing an Authorised Representative for your medical device or IVD company is a serious decision, one which will affect you for years. Careful consideration of the points outlined above - your needs, their experience, the company's history, and the question of appointing a distributor - will help you make the best decision for your company.