July 20, 2020 | News
BRUSSELS, Belgium: In order to repair the economic and social damage caused by the SARS-CoV-2 pandemic, the European Commission is proposing a major recovery plan for Europe, based on harnessing the full potential of the EU budget. This recovery plan consists of a twofold response: Next Generation EU and a reinforced long-term EU budget. Next Generation EU will be rolled out across three pillars: supporting member states to recover, repair and emerge stronger from the crisis; kick-starting the economy and helping private investment; and learning lessons from the crisis.
July 20, 2020 | News
BRUSSELS, Belgium: On 19 May 2020, the European Commission issued guidelines on EU-wide derogations for medical devices. The guidelines follow the commission’s earlier proposal to defer the date of application of the medical device regulation to 26 May 2021 in the light of the SARS-CoV-2 pandemic.
July 20, 2020 | News
In the past four months, the global economy has suffered the unprecedented impact of the SARS-CoV-2 pandemic, and the dental industry in particular has been one of the most severely affected. We have seen an almost total loss of turnover for dental businesses in many countries, and only now are we seeing the first green shoots of recovery. It remains a fragile situation, and without a vaccine, we are treading a fine line with local lockdowns due to regional outbreaks of the virus and the spectre of a potential second wave this autumn.
May 29, 2020 | News
LEIPZIG, Germany: Many governments have now eased public health restrictions, saying that their countries have overcome the first wave of the SARS-CoV-2 virus. Dental practices have begun to reopen across Canada, the US, India and parts of Europe, and staff and patients are having to adjust to a new sense of normality in the provision of oral care. Health precautions vary in different dental markets, but it can safely be stated that a trip to the dentist is not what it was in February.
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.