How to change Authorized Representative #
In some cases, medical device companies may wish to change their AR, perhaps due to a lack of responsiveness, cost, or overall service quality they may currently be receiving. The EU Regulations tackle changes in Authorized Representatives in Article 12, providing some guidance as to how to manage the transition which involves one of the parties drafting up a three-way agreement that lays out the following aspects [AR Mandate]:
- Date of termination of outgoing AR and start date of the mandate of the incoming AR.
- Date until which the outgoing AR may be indicated on the information supplied by the manufacturer.
- Transfer of relevant documentation.
- Obligation of the outgoing AR to forward to the manufacturer or incoming AR any complaints or reports received related to a device it used to cover.
This might seem like a big hassle, but when timed right, it is a relatively straightforward process. Here are some key considerations when switching to a new AR for your existing products:
- Labels & IFU: The AR details on the labels, IFU, and packaging artwork will need to be changed. This will need to be performed in accordance with your document control procedures to ensure that there are no further elements that will need to be amended. Therefore, a good time to switch may be on your next print-run, to avoid further cost.
- Existing Mandate: Read the terms and conditions of your existing mandate closely and make sure you understand any related termination requirements and charges. Switching AR towards the end of your agreement (for example, two months before you are due your annual invoice) means you get a smooth transition to your new AR.
- Product Groups: The Regulations are clear in that you must have only one Authorized Representative per generic product group. This implies that you are allowed to have a different AR for different product groups. Therefore, if you are introducing a new product on the EU market, now may be a good time to contact a new AR for that product group.
- New Legislation: As discussed in previous sections, there has been a significant change in the obligations of Authorized Representatives in the EU Regulations (MDR and IVDR) when compared to the previous medical device directives (MDD, AIMDD, IVDD). If you have legacy products covered by your existing AR, it may be easier to appoint your new Authorized Representative under the Regulations. Depending on your existing mandate, this may be a very easy and clean-cut transition to the new AR.