The MDR has implemented quite some surprises for medical device manufacturers who are not established in the EU. They need an authorised (authorized in American English) representative who is established within the EU. That’s clear for most manufacturers as they already have importers and they are somehow authorised.
But the MDR changes this game radically.
The magic date 26th May 2020 is approaching and from that day onwards MD manufacturers need a totally different kind of authorised representative (AR). The new AR is fully liable for most of the risks that occur when placing a medical device on the European market. The new AR needs to have full access to the entire documentation of the device. The documentation must be presented to the Notified Body and the Competent Authority on request without delay.
So this new AR is more like an attorney in the EU who needs to take care of all regulatory tasks and issues. The new AR has nothing to do with marketing and sales.
Impact on CE mark
It is very common in the MD industry to have an EU importer who at the same time carries the title “Authorized Representative”. In this old role it is rather simple to exchange the representative with a different one if the manufacturers expectations are not met.
In regards of the CE mark under the MDR this opens a big risk. The new AR is ultimately the holder of the CE mark. If for any reason the contract between the AR and the manufacturer is invalid the manufacturer is immediately at risk of loosing the CE mark. This means: End of business in the EU until a new representative is under contract and the CE mark is approved from fresh.
Peace of mind by valid MDD certificate? Not at all.
Although it is possible to sell medical devices in the EU after the 26th of May 2020 when they have a still valid MDD certificate there is no reason to relax. There are several conditions attached to that grace period.
Even if you have the newly designated Authorised Representative in place and even if you do not make any substantial changes in design and intended purpose of the device there are plenty of things to have in place by 25th May 2020 even for class 1 devices. Most manufacturer obligations like PMS and PMCF have to be established and followed, the QMS has to be fully MDR compliant (despite that no certification is required explicitely), etc.
There are only a few months left to have it all established! No time to loose. If you have any feel like “am I really prepared well enough?” or “how can I know I have everything in place?” please call your best advisor on MDR topics and do the checks.