Chief Executive of British Dental Industry Association addresses Brexit concerns
BRUSSELS, Belgium: Decisions regarding Brexit are coming closer, and industry in general is increasingly concerned about how the post-Brexit landscape may look. The dental industry will have plenty to contend with, and in a recent article, Edmund Proffitt, Chief Executive of the British Dental Industry Association (BDIA), sought to break down some of the most pressing issues about next year’s introduction of the new EU medical devices regulation (MDR) and what it will mean for the British dental industry.
In the article, titled “Still sailing into the perfect storm”, Proffitt was quick to mention that the industry is facing a great deal of uncertainty, as things once perceived as abnormal are becoming the new normal.
The MDR will mean that, for the first time, importers and distributors will have legal obligations. This will relate to areas such as the legality of products, CE marking, documentation and post-market surveillance. “Organisations will need to look at quality management systems, possible product sampling, and there is even some talk of importers and distributors having to register with the MHRA [Medicines and Healthcare products Regulatory Agency] at some point,” said Proffitt in his article.
According to Proffitt, this means that the UK dental industry could be caught between two regulatory systems: the new EU system and a new post-Brexit deal (or no-deal) UK system. This uncertainty creates many headaches for all those involved. The European Commission has already acknowledged a possible pan-European short-term impact on the availability on the marketplace of some medical and dental devices next summer, noted Proffitt.
Speaking about notified bodies (NBs) and their capacity to deal with the ever-changing environment, Proffitt pointed out: “Under a possible no-deal Brexit scenario, UK device manufactures will have to rely on an EU-based NB to certify relevant products for sale, as UK NBs will not have any power to issue CE marks to allow products on the market, so we could find ourselves in the perverse situation that the UK would, for a period, not be able to certify UK-manufactured products for sale on to the UK market.”
Earlier in the year, the European Commission published an MDR factsheet which provided EU healthcare professionals with an introductory guide to the MDR. According to Proffitt, “It is one of the few occasions the EU [European] Commission has directly acknowledged the implications of MDR implementation on product availability.”
Spelling out a few different possibilities for dental suppliers, Proffitt stated that he believed that an EU-wide solution is the preferable option. If this is not in place, there could be 27 or 28 different national regimes across the EU.
Despite the huge amounts of work and effort being put in by the dental industry to mitigate as many of the variables as possible, there is still a chance that, in the summer of 2020, the post-Brexit deal (or no-deal) could impact the supply and availability of some dental products as manufacturers and distributors adjust to changes and associated costs.