Takeaways from an Unforgettable IDS 2019
The team from Richmond Dental and Medical supports the local dental community in many regions across the US, as well as the national and international communities of dentists and other dental professionals as we visit and exhibit at trade shows around the world each year. This March, we spent an unforgettable week in the German city of Cologne for IDS 2019, one of the leading trade fairs that brings together the German, European, and global dental communities.
Over the five days of IDS 2019, Richmond joined more than 2,300 supplier companies from 64 countries, networking with more than 160,000 trade visitors from 166 countries. 73 percent of the show visitors were from abroad, representing countries from Europe, Africa, Asia, South America, and North America.
Brexit Looms Large
A pair of events stole the show for the Richmond team—meeting with the British consulate to learn about the UK government’s take on the ongoing Brexit negotiations and how the impending move away from the European Union will change the British dental industry in multiple ways. Examples include the way it accepts foreign dental workers, intellectual property with regard to medical devices, and the issue of creating a “hard” border between Northern Ireland, which is part of the UK and leaving Europe, and the Republic of Ireland, which will remain in Europe post-Brexit.
The German Dental Behemoth
We also heard an informative talk from Gabriel Flemming, manager for the healthcare sector for Germany Trade and Investment (GTAI), the country’s economic development agency. Flemming spoke about the context of Germany’s global contribution to healthcare, as well as its particular focus on innovation in dentistry.
According to Flemming, the USA and France are Germany’s two largest trading partners, and the German dental market ranks third worldwide—behind only the USA and Japan, and first in Europe, with more than 22 million euros spent annually on dental treatment. There are 94,000 German dentists, or one for every 1,145 residents, performing 1.3 million implants per year.
And the influence of the German dental industry doesn’t stop at treatment. Germany is dominant in dental manufacturing (number two worldwide, with two-thirds of production for export). A full one-half of all German device manufacturers are focused on the
dental market, with more than 200 implant systems developed by German firms.
MDR versus MDD
The German market, along with the rest of Europe, is undergoing a sea change due to regulatory overhaul for medical device development and approval. The European Union is currently migrating (through 2020) to the new Medical Devices Registration (MDR), which replaces the former Medical Devices Directive. The new registry will specifically regulate medical and dental devices, as well as in vitro diagnostic devices. The updated registry, targeted at manufacturers, importers, and health institutions, will bring EU regulation in line with advances in the innovation, changes in medical science, and progress in lawmaking.
Mr. Flemming further explained that while dental implants are considered class IIB, they will simply run a pass/fail system as opposed to multiple clinical trials, while their IIB counterparts like hip implants will receive major scrutiny. The MDR will require more documentation for approvals, with technical documentation augmented by clinical documentation for successful negotiation of the new regulations. The MDR will also require unique device identifiers (UDIs) for all devices, to improve the identification and traceability of all medical devices.
Overall, the new regulations will seek to improve safety and quality of all devices sold in the EU market.
The costs for manufacturers in the near term will be 10 times greater to register devices with the MDR vs the old MDD. Costs and regulatory red tape have been compounded by the simultaneous effects courtesy of Brexit, as manufacturers will see an increased workload to stay compliant and be able to sell in both Britain and the EU moving forward.
We are grateful to both the British consulate and the GTAI, as well as the team at IDS Cologne, for bringing together some of the best minds from across Europe and around the world to discuss the latest factors affecting the future of our industry. Richmond Dental and Medical will continue to monitor the industry to provide the best products and customer service to dental professionals worldwide.