February 25, 2020
BRUSSELS, Belgium: The UK officially left the EU on 31 January 2020 with a withdrawal act providing for a transition period until the end of 2020. A specific question to be considered is whether the UK will take part in the new EU medical device regulation (MDR) after this transition period.
February 25, 2020 | News
BRUSSELS, Belgium: The European medical device regulation (MDR; Council Regulation (EU) 2017/745) will enter into force on 26 May 2020, replacing the active implantable medical device directive (Council Directive (EEC) 90/385) and medical device directive (Council Directive (EEC) 93/42). By then, all medical device manufacturers will need to be compliant and distributors will have a number of new obligations.
As a senior consultant at Henry Schein and a board member of the German dental trade association Bundesverband Dentalhandel, Andreas Meldau had the exact expertise necessary for his election as ADDE vice president in Brussels last year. In this interview, he discusses the European dental trade and the ADDE’s priorities for improved information sharing and member development.
CHESHAM, UK: The medical device regulation (MDR) brings a raft of additional responsibilities for manufacturers’ quality and regulatory affairs teams. Moreover, they will also need to familiarise themselves with new obligations for other economic operators—such as authorised representatives, importers and distributors. In a recent article for the British Dental Industry Association, Adam Stanley discusses the first set of guidance documents the Medicines and Healthcare products Regulatory Agency (MHRA) has shared for economic operators—in this case, addressing the obligations of distributors under the MDR.
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.
BRUSSELS, Belgium: On 25 October, the European Commission’s Medical Device Coordination Group (MDCG) released a document providing an overview of future guidance documents related to the new Medical Device Regulation (MDR) as well as the in vitro diagnostic medical device regulation (IVDR). The document notes that much of the guidance will be endorsed by the MDCG later this year or in 2020.
July 2, 2019 | Interviews
Paolo Bussolari has been with multi-business group and dental product manufacturer Cefla since 2001 and has served as Managing Director of Cefla Medical Equipment since 2013. In this role, he is responsible for the general direction of the Cefla business unit, which deals with the development of all products manufactured by Cefla’s brands. He spoke to Dental Tribune Online about current developments in Cefla Medical Equipment and about manufacturer–dealer relationships.
BRUSSELS, Belgium: The Vertical Block Exemption Regulation (VBER) exempts certain agreements from the EU’s general competition rules and allows suppliers to restrict a distributor’s active sales to a specific territory or customer group. Because the regulation expires on 31 May 2022, the European Commission launched a public consultation aimed at stakeholders and citizens earlier this year to check whether the regulation is still relevant. The Commission is currently reviewing whether it should allow the VBER to lapse or prolong or revise it. This review is especially necessary because of the increase of online sales and market platforms which affect the distribution and pricing strategies of manufacturers and retailers.
June 21, 2019 | News
BRUSSELS, Belgium: On 25 May, the General Data Protection Regulation (GDPR) reached the first anniversary of its effective date for enforcement. The GDPR is a single set of rules regarding the protection of personal data and is directly applicable in the EU member states.
June 12, 2019 | News
BRUSSELS, Belgium: The Association of Dental Dealers in Europe (ADDE) recently elected a new president, vice president and board members during its 55th annual general assembly. The board is composed of representatives from leading European dental industry associations.
October 30, 2018
BRUSSELS, Belgium: The EU member states are losing billions of euros in value added tax (VAT) revenues each year. The resulting VAT gap, the difference between the expected VAT revenues and those that are eventually collected, provides an estimate of the revenue lost owing to tax evasion and avoidance on the one hand and bankruptcies, financial insolvencies and miscalculations on the other. On 25 May 2018, the European Commission proposed final technical measures to create a fraud-proof EU VAT system.
October 30, 2018 | Interviews
For clinics, hospitals and private doctors who are looking to invest in new equipment or services, renting and leasing are becoming increasingly more viable alternatives to purchasing. BNP Paribas Leasing Solutions subsidiary supports these end consumers, as well as healthcare equipment dealers, manufacturers and providers in their growth through renting and leasing solutions. Dental Tribune International spoke to Ariane Govignon, head of the Healthcare market, about BNP Paribas Leasing Solutions’ mission, what it means to health professionals, and its recent collaboration with the ADDE.
October 30, 2018 | News
The ADDE, in collaboration with the British Dental Industry Association (BDIA) and following its sister organisation, the Federation of the European Dental Industry, has issued a letter outlining dental dealers’ priorities in the Brexit negotiations. The letter, which was addressed to European Chief Brexit Negotiator Michel Barnier and Secretary of State Dominic Raab, has now received a reply from the European Commission’s Taskforce on Article 50 negotiations with the UK.
BRUSSELS, Belgium: Health Technology Assessment (HTA) is an independent, objective and evidence-based system used to measure the added value of new health technologies. Joint assessments at EU-level covering clinical, but in some cases also social, economic and ethical issues, have been ongoing since the 1980s. However, a series of shortcomings in the current cooperation model has necessitated that the European Commission put forward a new proposal enabling a sustainable and more effective European cooperation on HTA.
After joining the family business in 1984, engineering graduate Peter Malata followed in his father’s footsteps as W&H’s president in 1996. Since 1890, the now family-owned W&H is one of the leading manufacturers of dental precision instruments and devices in the world. Currently, W&H has around 1,100 employees worldwide, two production sites in Bürmoos in Austria, one in Brusaporto in Italy, and a total of 19 subsidiaries in Europe, Asia and North America. Dental Tribune Online spoke with W&H President Peter Malata about the company’s history, vision and its ADDE sponsorship.