Walking the regulatory tightrope after Brexit
Could changes in regulations twinned with Brexit affect dental product supplies? Edmund Proffitt talks to Julian English about this complex issue.
The potential impact of the new medical devices regulations (MDR) arriving around the same time as Brexit next year could represent a ‘perfect storm’ in terms of supply of products to UK dentists. In fairness, the directives arriving on 26 May 2020 would, on its own, have a very significant effect on all manufacturers.
Also, for the first time, this brings a legal obligation for distributors, wholesalers and importers, too. The supplier must ensure products are CE marked, have instructions for use in the English language, and have adverse issues reported and fed back to the manufacturer.
The manufacturer also will have much tighter regulation and controls. This is significantly compounded by the fact the notified bodies (the organisations responsible for granting CE marks and ensuring the certification procedures is in order) are reducing in number to a chronic level.
Brexit aside, there are major problems for manufacturers getting the right paperwork certification for the UK marketplace. Earlier this year, one notified body pulled out of dental device certification, effectively orphaning hundreds of dental products for sale.
Others have narrowed their scope, reducing the availability of certification services for dental products.
It has had a knock-on effect. Probably the biggest issue for dental product manufacturers is every dental product will need recertifying. This includes a complete and thorough recertification to the new standards over the next few years. There will be much stricter criteria to meet under the new rules. And, of course, significantly increased cost incurred for this.
There is a belief that many smaller volume products may not be viable for sale because of the stricter and more expensive bureaucracy needed. However, up to 2024 and under the current rules, valid certification enables continued selling of products. This will be a rolling process.
As product transfers from the old regulatory system to the new, there may be some hiccups in the supply of dental products and materials to UK dentists.
Up classification issues
Adding to the confusion, some products, such as alginates and some restorative materials that may release nano-materials, may have to be up classified as class II a or even class III product.
For the first time, reusable dental instruments will also require notified body involvement. The product will go from being self-certified at a lower cost to requiring certification of its reusability characteristics for compliance. This will significantly increase the manufacturer’s compliance costs. There is also a big debate about dental implants and their exact classification.
This is only not a British problem, it is pan-European. The French, Germans and Italians are aware of the potential problems. They are putting pressure on the European Commission to look at the implications of this on the delivery of dentistry across Europe.
It’s proving difficult to introduce a new regulatory system when the foundations are so shaky. The 50 or so notified bodies are profit-desiring companies. They are finding it too costly, time-consuming and increasingly not worth working on dental products. So much so there may only be about 10 left that are certified under the new regulations.
There are hundreds of thousands of products that need to be recertified and not enough people to do it. Certified bodies are pulling out because of the liability they would have to carry, too.
What will happen with Brexit?
Until a few years ago, the UK Medicines and Healthcare products Regulatory Agency (MHRA) used to lead and drive regulation on medical devices. But with Brexit it has lost this influence, to the detriment of everyone involved.
With no Brexit, the current rules from Europe apply. Brexit with no deal: our regulator, the MHRA, has a carbon copy of the European regulations. These will be helicoptered into force overnight. But Brexit activity itself has led to a degradation of the influence of the MHRA on policy in Europe. And that was beneficial to the UK. The MHRA was forced to take a backseat after the referendum and confusion has increased as a result.
When Brexit happens, the UK will not be able to use a UK-notified body to certify and sign off any products to sell in the UK.
European Commission regulatory standards was seen as the gold standard. But now they’re viewed as over complicated, creaky and expensive. The European Commission has published a factsheet. It provides an introductory guide to the MDR for healthcare professionals (including dentists) across the EU, ahead of the changes to the regulatory processes coming into force in May 2020, and while the Brexit process continues.
This document is one of the few times the European Commission has directly acknowledged the implications of MDR implementation on product availability. It states: ‘These changes could have consequences for the availability of medical devices for health institutions. For instance, manufacturers may choose to stop the production of certain medical devices. Furthermore, if certain medical devices do not get their certificates on time these products may become temporarily unavailable.’
For more information visit www.bdia.org.uk.
Published first in Dentistry magazine. If interested in signing up to receive Dentistry magazine, visit www.fmc.co.uk.