BDIA leads EU initiative on Brexit

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BDIA and FIDE issue joint letter outlining priorities for Brexit negotiations

The British Dental Industry Association (BDIA) and Federation of the European Dental Industry (FIDE), as the trade associations representing the dental industry in the United Kingdom and Europe, have issued a joint letter outlining their priorities for the ongoing Brexit negotiations.

The initiative, proposed by the BDIA, saw a letter addressed to the European Chief Negotiator for Brexit, Michel Barnier and the Secretary of State for Exiting the European Union, David Davis, highlighting the important economic and public health role played by the dental technology and devices sector, and calling for action to be taken to safeguard it.

BDIA Chief Executive, Edmund Proffitt (above) comments, “The measures outlined by our associations would ensure that our industry is able to continue to provide access to innovative dental technology in the UK and throughout the EU, to the benefit of patient oral health and the economy, beyond the UK’s exit from the EU in March 2019”.

Chief amongst these measures is a commitment to parity of UK and EU legislation after Brexit. The UK’s decision to leave the European Union came at a critical point for the dental industry, coinciding with the publication of the EU Medical Device Regulations (MDR), and future divergence in legislation would risk disadvantaging both patients and businesses across Europe.

Other priorities to ensure a successful outcome to the negotiations include the maintenance of the Medicines and Healthcare products Regulatory Agency’s involvement in ongoing discussions concerning medical device regulation, the continued adoption of the CE marking process for medical devices and allowing UK Notified Bodies to operate under the MDR.

The text of the letter, sent yesterday, 26th October, was as follows:

Dear Mr Barnier and Secretary of State,

As the trade associations representing the dental industry in Europe and the United Kingdom, the Federation of the European Dental Industry (FIDE) and the British Dental Industry Association (BDIA), we would like to highlight the important role that dental technology and the dental devices sector plays in public health, and the measures that can be taken to safeguard the sector during the ongoing "Brexit" negotiations.

In the UK, the dental industry employs around 8,000 people in over 300 companies. The industry generates a turnover of €490 million annually and supports the treatment of over 15 million UK patients every year. This represents one of the leading markets in Europe, where the industry has a total annual turnover of around €6.7 billion, average annual growth of2.7% for the past five years and employs about 45,000 people in 550 companies.

The dental industry and the EU and UK citizens it serves have benefitted greatly from the European Single Market and a consistent, shared regulatory environment. EU-wide medical device legislation, which provides market authorisation via CE marking, has facilitated delivery of high quality care to patients for over 25 years, enabling timely access to safe, effective and innovative dental technologies.

Recently published EU legislation, the Medical Device Regulation (2017/475), will be applicable in the UK until it leaves the EU in March 2019. Thereafter, there is a risk that UK and EU legislation may diverge, to the detriment of patients and businesses across Europe. We believe that there should be a commitment to parity of UK and EU legislation, and that a transition period may be necessary to achieve this.

The UK has played a major role in the development of dental and medical device regulation in Europe for many years. The UK's Competent Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), enjoys a preeminent position internationally and it would benefit all parties concerned for this to continue, especially in the context of a trend towards global harmonisation.

The production and supply of dental devices often involves a complex cross-border network across Member States. In other international markets it is non-tariff barriers, often arising from conflicting regulatory regimes, that most seriously limit trade. Ensuring that such barriers do not emerge between the EU and UK will be crucial in protecting the future oral health of EU and UK's citizens, and the global competitiveness of European dental businesses.

A comprehensive agreement including the following points would avoid disruption to innovation and growth, increases in bureaucracy and cost, or limiting patient access to treatment:

1. EU Medical Device Regulations to be adopted in the UK;

2. The UK is able to remain an active participant alongside Member States in the European regulatory framework (CE marking regime) for medical devices;

3. UK Notified Bodies (NBs) would remain European designated NBs

4. Legal entities located in the UK, such as Authorised Representatives or legal manufacturers, would be considered as "European-based" under the MDR;

5. The MHRA has the opportunity to participate formally in the European Commission's new Medical Devices Coordination Group (MDCG);

6. The UK maintains full involvement and participation in the European Database for Medical Devices (Eudamed)

For these reasons we believe an appropriate transition period may be necessary to allow our sector to allow implementation of the necessary measures to ensure the continuity of access to dental technologies in the UK and the EU post-March 2019, while providing much needed certainty and stability for business.

We are keen to continue engaging with both the UK and EU authorities during the ongoing negotiations, and would welcome the opportunity to discuss these issues with you in greater detail.