British Dental Industry Association
BDIA
The BDIA is the UK's principal body representing the dental industry.
ID: 294004818332-17
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
The British Dental Industry Association welcomes efforts to address the systemic challenges facing the regulation of medical devices under the EU MDR. We believe that a targeted legislative intervention, coupled with appropriate ongoing support and oversight, can support patient outcomes through improved access to dental devices whilst creating a more supportive environment for manufacturers and other economic operators. Inconsistencies between Notified Bodies creates challenges for manufacturers. Different NBs will have different interpretations of device classification, clinical evidence requirements, different account management practices, different audit procedures and different understandings of the EU MDR and MDCG/MEDDEV guidance. Similarly, there is a lack of consistency within Notified Bodies, i.e. different interpretations and practices from one auditor to another. Auditors may also lack necessary levels of experience. Manufacturer relationships with NBs could be improved through contractual provision for structured dialogue, including pre-application dialogue, to allow manufacturers to ask questions and for Notified Bodies to address issues at an early stage, ensuring a common understanding. NB contracts should also include binding timelines for review in order to provide transparency and predictability for manufacturers. Greater clarity should also be provided around rules for NBs offering consultancy to address concerns that provision of regulatory information by NBs that should not be captured by the proscription of consultancy is being withheld. Manufacturers have highlighted the challenges arising from the EU MDRs restrictions on equivalency, with the requirement for full access to another manufacturers technical documentation, with it being noted that these requirements are more restrictive than those of other international regulators. Adopting a more risk-based approach in this area could enhance the competitiveness of the EU whilst improving patient access to devices. The EU MDR currently takes a one size fits all approach and could better distinguish between the needs of, and regulatory pathways for, new and established devices. Specific pathways and mechanisms should be included for identifying and supporting new and innovative/breakthrough devices. A move toward greater digitisation, including further expansion of eIFU and introduction of digital labeling, should also be pursued. We support the establishment of a new central authority with responsibility for medical device regulation, the remit of which would include ensuring a consistent and unified approach across Notified Bodies, as well as dispute resolution. This authority could follow a case law approach in order to achieve consistency, ensuring that precedents established in one Member State are adopted uniformly. This authority would also have an important role in enforcement of the EU MDR, ensuring that national Competent Authorities provide consistent and robust action to address non-compliance. Inadequate oversight and enforcement activity threatens patient safety and undermines confidence in the regulatory system by allowing counterfeit and non-compliant product to be manufactured, supplied and put into service freely. In order to safeguard the continuity of supply whilst this reform of the EU MDR is underway, we support the extension of the validity of already issued certificates, with a view to ultimately transitioning away from a regular recertification model entirely and instead operating a risk-based model of lifetime certification, supported by the EU MDRs enhanced PMS requirements. Legislative revision of the EU MDR should support the principles of transparency and predictability whilst working toward an overall reduction in complexity and a greater focus on risk proportionality, thereby reducing the administrative burden on manufacturers, increasing system efficiency and enhancing patient access to devices.
Read full responseResponse to Implementing regulation for electronic instructions for use for medical devices
20 Mar 2025
The British Dental Industry Association (BDIA) supports the proposed expansion of the provision of electronic Instructions for Use (eIFU) under the Medical Devices Regulation (EU MDR). The current provision for eIFU under the EU MDR is unnecessarily restrictive, and the proposed Implementing Regulation (EU) 2021/2226 is a welcome step. The expansion of provision of eIFUs would reduce costs and administrative burdens for manufacturers whilst ensuring that users continue to have access to up-to-date information, thereby enhancing patient safety. In a rapidly evolving regulatory landscape, the expanded use of eIFUs would allow manufacturers to respond more efficiently to any changes in requirements, reducing costs and protecting continuity of supply while ensuring that outdated information does not remain in circulation. Elimination of unnecessary printed material will also contribute to the sustainability of the medical device sector. We would encourage the Commission to view this step as part of a broader drive towards digital regulatory solutions and, particularly in light of its targeted evaluation of the EU MDR, to consider other opportunities to leverage digital technologies for the benefits of patient and industry, such as a move toward e-labelling where pragmatic to do so.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
20 Mar 2025
The British Dental Industry Association (BDIA) welcomes this targeted evaluation of the Medical Devices Regulation (EU MDR) and the Commissions recognition that action is needed to address the systemic challenges that have, since its implementation, jeopardised the availability of medical devices, restricted the introduction of new and innovative products and that have compounded the significant regulatory pressures facing industry. Since the extended transition periods introduced by Regulation (EU) 2023/607, industrys focus has shifted from the cliff edge threat to continuity of supply that had existed to the significant structural challenges facing the regulatory framework. Notified Body (NB) capacity remains a concern, despite these extended transition periods, and any efforts to reduce administrative workloads by eliminating unnecessary and duplicative processes should be encouraged. As such, we would encourage the Commission to follow the recommendation of 2024/2849(RSP) to address bottlenecks, improve transparency and remove unnecessary administrative work and to eliminate unnecessary re-certification of products. Such steps should also be seen as an opportunity to reduce, wherever possible, the often prohibitive cost of regulatory compliance. A key area for improved transparency is in relation to NB fees. Despite the Article 50 requirement for the publication of standard fees, the information available remains inadequate and manufacturers should have access to more detailed information to enable an understanding of the cost of regulatory compliance in advance. Similarly, a lack of transparency and predictability has long undermined the ability of manufacturers to navigate the regulatory landscape in a timely and efficient manner. Inconsistencies between NBs creates an uneven playing field, while inconsistencies within a given NB (for example, different interpretations of non-conformities between individual auditors) hinders manufacturers, delays certification and creates a barrier to compliance. Standardised processes and timescales, enshrined in contracts, should be established to address this issue. The conformity assessment process could be made significantly more efficient, transparent and predictable through the support of enhanced pre-application dialogue between manufacturers and NBs. The Commission should support the Parliaments call for structured dialogue between manufacturers and NBs at all stage of the certification process, but particularly pre-application. The EU MDR is in need of significant overhaul in order to support manufacturers and other economic operators in the delivery of essential products and services for patient care and public health. The current systemic challenges threaten device availability, discourage innovation and undermine patient care, and we call on the Commission to address these issues as a matter of priority.
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