Dr. Gert Bos, CTO & Partner of Qserve Group, was interviewed on Dutch Television (EenVandaag) because of the no-deal Brexit discussions yesterday (12 March). Dr. Bos answered questions regarding the risks on a reduction in the number of medical surgeries at Dutch hospitals due to the effect that there will be less medical devices available in case of a no-deal Brexit. Part of the interview was broadcasted; the full version of the interview is below.
Starting point is the Q&A document the EU has published to clarify the situation in medical device and IVD field, in the event of a no-deal Brexit.
So what is the effect of the positioning of the EC for manufacturers and care-givers?
Some effect is there for manufacturers that utilize importers to EU that are located in the EU. These will need to be changed to EU 27 entities, and goods will need to be shipped. Similarly, UK-based authorized representatives will need to be replaced by EU 27 ones, and these new authorized representatives with name and address will need to appear on the label as of March 30, 2019. The biggest impact, however, is for manufacturers that have their certificates issued by UK-based notified bodies, accounting for approximately 30% of all medical devices and IVDS available in EU.
The manufacturers can be distinguished into two categories: those with a sister organization in EU 27, and those without. Two notified bodies are in the first group, and they are working day and night to migrate as many certificates as possible; the other two, and their clients, are not so lucky. An estimated 70-80% of the affected UK-issued certificates will be transferred before March 29, 2019.
For hospitals and other care-givers, the first impact is to find out which products are at risk. Of those then to order and pay in advance where possible, as products produced, packed and sold before March 29 may continue to be shipped to the end user. The alternative is to start looking for alternative products.
What makes transfer of certificates so difficult?
Due to the transition into a new stricter regime for medical devices and IVDs in Europe, around 1/3 of the notified bodies has stopped operations. Another third is restricted in scope of products they may certify.
Secondly, the stricter requirements are simply taking more time to review. Capacity challenges hence ensure that on average 12-18 months is currently needed for a certificate transfer.
And such timing is incompatible with the fast actions required in the case of a no-deal Brexit.
Why do manufacturers not provide the list of available products?
Simply said, manufacturers have prioritized the upgrading of products into the new law. Those with already improved documentation will be more easily transferred than those that are still on the to-do list for upgrading during the transition period. In addition, there is such a pressure on resources at notified bodies, that manufacturers may only know days or hours in advance if their products will secure an EU 27 certificate in time. Simply put, they do not have a full picture, and are waiting for clarity before they instruct the distribution chain.
Did manufacturers not take action?
Oh yes, they did. Many worked on increasing the inventories in EU 27 as well as UK. So products are there. Key however is the debate around mandatory relabeling form March 30 onwards.
Secondly, manufacturers not affected by Brexit-certificates have also in many cases increased their stock, in order to be able to support any shortages.
Lastly, industry has issued a plea for a transition period in the field of medical devices and IVDs, similar to the agreed transition that would fall in place in case there would be a deal; in the interest of patients safety and continued care.
Where may we anticipate first problems?
Word is going around in EU that the first problems may actually start in the hospital laboratories. Many of the available tests are only short-lived. For much used tests such as blood typing tests, and other blood safety tests, every batch needs a new certificate. And unfortunately, a lot of these critical products have been certified by the UK-based bodies tat have no sister organization in EU 27 to whom they may migrate the certification process.
I believe we should look forward to opportunities and solution to continue the care for patients throughout the EU, EU 27 and UK, in case of a no-deal Brexit, by making sure medical devices and IVDs will continue to be available to doctors and patients needing them. All stakeholders should engage to do what is in their powers.
Hospital can increase stock, buy products that have already been packed and are in warehouses anywhere in the world. Certification bodies and authorities may clarify the confusion on required re-labeling. And manufacturers can make resources available for re-labeling, as well as find other solutions to support the availability of emergency stock.
Are you worried?
I guess we all are. But we should realize that people working in healthcare, whether in hospitals, at manufacturers, authorities or certification bodies, have passion for the work, and compassion with the patients. I’m sure everyone will do what they can to ensure continued patient care!
For more information, please contact dr. Gert Bos via e-mail: firstname.lastname@example.org.
Watch the broadcast (Dutch language).