First stakeholders meeting on medical devices

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First stakeholders meeting on medical devices


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Various dental associations met for the first stakeholders meeting on medical devices in Brussels. (Photograph: Dental Tribune International)
Dominique Deschietere

Dominique Deschietere

Wed. 26. April 2017


Dear ADDE members and supporters, the first stakeholder meeting in Brussels on 23 February provided a great opportunity for promoting European dentistry and securing the interests of dental professionals and patients in light of the new medical device regulations. Various dental associations and members participated in the first-rate event, which provided insights into the new medical device regulations. Two European Union experts spoke about the regulatory framework’s intended impact and outcomes.

The meeting began with introductions to the various associations by their representatives. As president, I started by introducing the Association of Dental Dealers in Europe (ADDE). Established in 1964, the ADDE is an associate member of the FDI World Dental Federation, an active member of UEAPME and a close partner of the Federation of the European Dental Industry (FIDE) via the European Dental Business Committee. The ADDE represents the interests of about 50,000 dental dealers. Our members are partners in the provision of innovative solutions to all dental professionals in the European market. The ADDE supplies information and guidance about medical device regulation and new and emerging technologies, such as intra- and extra-oral scanning, milling, laser sintering and other 3-D printing. Finally, the ADDE addresses unfair competition from businesses who do not comply with health and safety requirements, whether located outside or inside the EU.

Founded in 1961, the Council of European Dentists (CED) represents 340,000 dental professionals in Europe. Currently, the CED has 29 full-member national dental associations and three that have observer status. As an independent body financed by membership fees, its mission is to promote a high standard of oral health, dentistry and dental care, effective patient safety and evidence-based professional practice across Europe. In addition, the CED promotes the interests of the dental profession and contributes to protection of public health. “Patients are at the centre of our mission. The European citizen as a patient is our main concern,” said Dr Marco Landi, President of the CED.

Representing 40,000 dental laboratories and 210,000 dental technicians in Europe, the European and International Federation of Dental Laboratory Owners and Dental Technicians (FEPPD) is another key participant in the dental trade industry. Founded in 1953, the FEPPD evolved from representing manufacturers to promoting European dental technology worldwide. It supports members through annual events, studies and EU-funded projects. The FEPPD aims for full transparency in the manufacture of dental devices. According to Secretary-General Pierre Zammit, the new medical device regulations should help to ultimately deliver the best service to the European patient.

FIDE was founded in 1957 and represents the interests of more than 550 dental manufacturers. According to President Dr Alessandro Gamberini, the main current issues of the dental industry remain medical device regulation, the Rule 19 classification, the capacity of notified bodies and 3-D printing. In line with the new regulatory framework, new and higher requirements for the dental industry will require more stringent clinical evaluation, technical reports, clinical follow-up and others. It has remained unclear whether the new medical device regulations will be only an additional burden for the industry and lead to withdrawal of products, and insolvency and closing of small companies. Gamberini also noted that the number of notified bodies in the EU has decreased, while the number of audits has increased.

The new medical device regulations
The medical device regulations have finally been adopted this month. The new regulation on medical devices will apply fully in spring 2020 and the new regulation on in vitro diagnostic medical devices in spring 2022. Certificates issued under the old directives will have a maximum period of validity of four years for medical devices and two years for in vitro diagnostic medical devices after entry into force. Devices available on the market will be valid for five years for medical devices and three years for in vitro diagnostic medical devices.

At the stakeholder meeting, the two EU experts spoke about a number of advantages the new framework will provide for manufacturers and dealers: stricter premarket control of high-risk devices with the involvement of EU-level experts, inclusion of certain aesthetic devices, reinforcement of designation and oversight processes of notified bodies, reinforcement of the rules on clinical evaluation and clinical investigation, stricter rules for substance-based devices, a new classification system for in vitro diagnostic medical devices and the introduction of a universal device identification system.

Much discussed topics were the establishment of a comprehensive EU database on medical devices (EUDAMED) with a large amount of the information being made publicly available, the introduction of an EU-wide requirement of an implant card containing information about implanted medical devices, the requirement of a summary of safety and clinical performance for all Class III and implantable devices, and new obligations for manufacturers and authorised representatives aimed at protecting consumers. In addition, questions remained about the registration of devices and economic operators, coordination between member states and the coordinated assessment of clinical investigations conducted in more than one member state. For this, the new EUDAMED and universal device identification systems, notified bodies and governance are the main priorities of the EU working group.

Interesting news and controversial discussions
Something not seen before is that the new regulations are directly applicable; thus, national governments did not have to vote to adopt them. The legislation has been restructured to allow for more intuitive access and a pro-active system. Scientific research and clinical evidence are now required. All manufacturers, even those of Class I and custom-made devices, will have to establish risk and quality management systems. The number of choices regarding conformity assessment has been reduced, so the EU has removed some procedures. The experts emphasised the establishment of unannounced audits and company inspections. In addition, the possibilities of own-brand labelling will be substantially reduced owing to the associated safety concerns.

A discussion arose around the question of whether dentists and dental technicians can be regarded as manufacturers of customised dental restorations, thus requiring certification of every implant, bridge and other restoration. Legislation has to define the scale and limit of mass customisation in order to ensure that dental laboratories are not considered industrial manufacturers. Dental professionals can find further information about these and other topics, including parallel trade, market surveillance and free movement of dental professionals, in the ADDE’s 2017 Survey on the European Dental Trade.

Further information will be available in our next newsletter. In the meantime, I would like to invite everyone to read the informative articles in this issue and take a look at the results of our new market survey, which will be available soon.

Dominique Deschietere

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