QA/RA News Archives – Orange-Moon

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.

EU Withdrawal Bill clears House of Commons – and is about to nuke MD companies

(Photo by frankieleon https://www.flickr.com/photos/armydre2008. Licensed under Creative Commons License https://creativecommons.org/licenses/by/2.0/legalcode.)

On January, 17th 2018 the British House of Commons agreed to a law that is putting a dramatic threat to the British medical devices industry. This bill shall establish a legal situation where the MDR/IVDR (EU 2017/745 – EU 2017/746) will not be “supreme” over British law anymore which in turn reverses the reliable framework for selling medical devices to EU-27.

With a fix date and time – 29th March 2019 – British companies will immediately need an “Authorized Representative” to continue selling MD equipment in the EU.
It is not only that an “Authorized Representative” is something very different then a sales representative. The authorized representative has to establish and maintain communication with the competent authority and the notified body.
In contrast to the MDD the MDR is putting the full liability for the device onto the authorized representative. Under MDD the liability was bound to the manufacturer.
Now, under MDR the authorized representative is in responsibility for the CE mark and carries the entire liability!

Practical impact

In practice this means that the authorized representative is a clone of the manufacturer on EU grounds – at least from the viewpoint of regulatory paperwork.

Some aspects are:

Direct access to all documentation
CAPA management
Post market surveillance
etc.

This steep cliff for most of the SMEs in MD industry is rolling towards Britian fast now. For those companies the MDR is hitting with full force immediately with the Brexit. Transition period? None. Most (probably all) common services who act as authorized representative under the old MDD will now assess if they really are prepared to take full responsibility.

Action required now!

Prediction: Most current authorized representatives will cancel the contracts and simply notify the competent authority about the fact. End of market.

It is highly doubtful that British companies are prepared enough for that scenario.

Our recommendation to all authorized representatives and manufacturers is to start assessing their legal grounds and find a solution that incorporates quality management and liability risk mitigation. It’s wise to be prepared.

The other way round

For EU-27 manufacturers there will also be some things to watch. This will be the topic of the next post. Stay tuned…

[Update 27th February 2018:]

The proposed article about the impact of Brexit on Medical Devices placed on British market from the remaining EU-member states has to wait. Unfortunately there is no reliable information from British government. The EU Withdrawal Bill now is in the second reading in the House of Lords and progress seems to be not too fast … .

(https://services.parliament.uk/bills/2017-19/europeanunionwithdrawal.html)

The only advice can be: Prepare for the worst and hope for the best.

In this context „Prepare for the worst“ means asking yourself: What would be appropriate action to prepare for the case when Great Britain leaves the EU with a hard Brexit on 29th March 2019, 23:00 GMT with installation of an entirely unknown new regulative environment?

Although this is somehow unlikely it is good to have this risk within your business risk reduction plan. In some cases it would be appropriate to import and store as much devices as possible within the UK. In other cases it would be appropriate to close down business as of 30th March 2019 and care for the other markets.

During the course of negotiations manufacturers and importers would be able to reduce the risk level and redefine the appropriate actions.

EU Authorised Representative Pitfalls