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.