On 6 January 2023, the EU Commission has published its concrete proposal for an amendment of the MDR and IVDR regarding the transitional provisions.

• EU-COM_MDR_Proposal_2023-01-06.pdf

Global recognition of benefits from topical fluoride-containing preparations, glass ionomer cement, silver diamine fluoride hailed as ‘huge step forward for oral health’

^{October 15, 2021 - By David Burger}

The World Health Organization announced Oct. 1 updates to its Model List of Essential Medicines for Adults and Children, three of which – topical fluoride-containing preparations (such as toothpaste), glass ionomer cement and silver diamine fluoride – are dental treatments featured for the first time.

The updated essential medicines list, which includes 20 new medicines for adults and 17 for children, had never deemed these dental preparations as essential until now.

“This marks a major achievement for oral health and public health,” said Jessica Meeske, D.D.S., immediate past chair of the ADA Council on Advocacy for Access and Prevention.

Dr. Meeske

“As a practicing pediatric dentist who sees a large number of low-income, high caries-risk patients, I have seen the benefits of fluoride, glass ionomer cement and silver diamine fluoride, and I am glad that their usefulness is recognized globally as essential.”

Under the leadership of Benoit Varenne, D.D.S., Ph.D., dental officer at WHO Headquarters in Geneva, Switzerland, the NYU Dentistry WHO Collaborating Center for Quality-improvement, Evidence-based Dentistry supported the applications for all three dental treatments for submission to the WHO Expert Committee, which included coordinating contributors, gathering evidence and drafting the application dossiers.

Adding them to the list for adults and children is a huge step forward for oral health and the prevention and treatment of dental caries, said Habib Benzian, D.D.S., Ph.D., co-director of the NYU Dentistry WHO Collaborating Center for Quality–improvement, Evidence-based Dentistry and research professor at the NYU College of Dentistry.

“With untreated caries affecting more than 2.5 billion people around the world, we need to change the paradigm towards priority for prevention and highly cost-effective care,” he said. “With the new essential medicine list now in place, stakeholders must ensure the dental preparations reach those who need them. This will require the translation of the global recommendations to national policy and action, including universal availability, steady supply, affordability and use of the essential dental medicines in primary oral health care.”

Sodium fluoride — without any further specification and as the only dental substance — has been on the WHO Model list since 1973 under the category of essential micronutrients, Dr. Benzian said, but the fact was not widely known and it had no visible public health effect. This update of the WHO essential medicines list includes a new section on dental preparation, he added, and the previous listing for fluoride was transferred from the section for essential micronutrients to the new section for dental preparations.

Dr. Benzian

The executive summary of the report said that its executive committee noted that the burden of oral diseases, particularly untreated dental caries, represents a significant public health problem globally.

“The committee noted that these products offer relevant benefits and can be used in atraumatic restorative treatment techniques and in non-specialized settings in alignment with WHO guidance on oral health interventions,” according to the summary.

The lists are updated every two years by an expert committee, made up of recognized specialists from academia, research, and the medical and pharmaceutical professions.

The decision came months after the WHO adopted a resolution on oral health calling for the development of a global strategy action plan, and monitoring framework for improvement of oral health globally until 2031, its first resolution on oral health since 2007.

The World Health Organization model list of essential medicines and those for children is found online.

^{Quelle: https://www.ada.org/en/publications/ada-news/2021-archive/october/who-includes-three-dental-preparations-in-essential-lists}

Milan, 22 July 2020 - the General Assembly of UNIDI members gathered together in the wonderful setting of Golf Castello di Tolcinasco on the outskirts of Milan to elect their new President on 21 July. The chairperson is responsible for heading the association throughout the next two years and, above all, for guiding it out of the current health crisis.

“It is an honour for me to take on the role of President of UNIDI,” stated Gianfranco Berrutti, “and a strong challenge at the same time.” We are all experiencing an extraordinary historic moment, and I am convinced that all associations (and ours in particular) will play a fundamental guiding role to help the relevant industry and entire supply chain involved.”

The new chairman’s programme for the upcoming months will focus on the 2020 Expodental Meeting, scheduled for 19-21 November in Rimini to make it a special edition, an important relaunch for the whole sector and chance to gather together, finally, for all industry players.

During the Assembly, members were also presented with an in-depth look at recent regulations that regard medical devices. In fact, UNIDI has worked together with other associations to achieve deferred implementation of the new EU Regulations 745/2017 (MDR) to 26 May 2021. Furthermore, members were informed that Confindustria Medical Devices has modified the association statute to allow UNIDI to join as an aggregate in upcoming months.

With the election of the new President, UNIDI also reorganized the Executive Board which is now composed of 9 members including the Chairperson: Gianfranco Berrutti, Simone Banzi, Paolo Bussolari, Attilio Carnevale, Luigi Fanin, Cristina Cesari Favonio, Emanuela Guerriero, Fabio Velotti, and Mario Zearo. Outgoing members are Gianna Pamich, President for the last 4 years, Edoardo Botteon and Lisa Micheletto.

Gianfranco Berrutti, class of 1968, a graduate in Business Economics from the Bocconi University in Milan, was already President of Unidi between 2012 and 2016 and then vice-chairperson until the latest appointment. Since March 2019, he has been President of FIDE, the Federation of the European Dental Industry, and in February 2020 he took on the role of President for IDM, the International Dental Manufacturers. He is CEO of the family business, Major Prodotti Dentari. In the association he has always played a proactive and prominent role, working effectively towards internationalisation and the development of Italian industries and the ‘made-in-Italy” reputation abroad.

UNIDI (Italian Dental Industry Association), which is part of Confindustria and a member of FIDE, brings together the best in the Italian Dental Industry: 120 companies producing equipment and materials for dentists and dental technicians. Since 1969 it has owned and organised the top trade show in the Italian dental industry, Expodental Meeting.

For further information:
Susi Marotti
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+39 340 7496695

Gianfranco Berrutti, the current President of FIDE, the Association of the European Dental Industry, which brings together associations of the national dental industry, was elected President of the International Dental Manufacturer Association during the last idm General Assembly, which took place on February 21^st  in Chicago.

President Berrutti was President of the Union of the Italian Dental Industry (UNIDI) and is currently UNIDI Vice President.

idm International Dental Manufacturers is the association that brings together dental industry associations from all over the world, representing the branches of the dental sector in individual countries.

The IDM General Assembly elected the following representatives for the 2020/2021 IDM Board:

Mr. Gianfranco Berrutti (FIDE) President

Mr. Fred Freedman (DTA) President Elect

Mr. Kiyotaka Nakao (JDTA) First Vice President

Mr. Phil Jolly (ADIA) Immediate Past President

>> IDM Board

Dr. Marsha Butler, Vice President & General Manager, Global Personal & Homecare Colgate Palmolive along side IDM President Phil Jolly receiving the 2019 IDM Global Health Program Award at the IDM Meeting in San Francisco in September 2019.

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UDI Conference 2014, Unique Device Identifikation.
The annual UDI Conference is the ONLY event dedicated to guidance and training for those impacted by the new UDI Regulation.

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